2^nd International Conference on Clinical Trials August 22-24, 2016 Philadelphia, Pennsylvania, USA

Biography:

Thomas E Serena is the Founder and Medical Director of Serena Group™, a family of wound, hyperbaric and research companies. He completed his residency in Surgery at the Hershey Medical Center. To date he has opened and operates wound care centers across the United Sates and globally. He has been the lead or Principal investigator in over 100 clinical trials and is recognized internationally as an expert in the field of wound healing: He has more than 100 published papers and has given more than 1000 invited lectures throughout the world. He has been a Member of the Board of Directors of the Wound Healing Society and served two terms on the board of the Association for the Advancement of Wound Care (AAWC) and is at present the President-Elect. He has also been Vice-President of the American College of Hyperbaric Medicine and President of the American Professional Wound Care Association.

Abstract:

Clinical research is an essential component of Serena Group’s™ Center-of-Excellence model for wound and hyperbaric centers. We are one of the world’s leaders in clinical research on wound care and hyperbaric medicine, having conducted over 100 clinical trials involving growth factors, gene therapy, bioengineered skin products, and novel pharmaceuticals. In 2011 Serena Group™ clinics conducted the research that led to the first diagnostic in wound care. The ensuing manuscript named the diagnostic procedure the Serena Technique©. In conjunction with Harvard’s Wellman Institute we developed and performed the initial clinical studies on a painless, bedside epidermal skin-harvesting device that is functioning not only in hospitals in the US but in third-world clinics as well. Our emphasis on clinical research over the years has drawn a group of young clinicians and scientists to participate in our research projects in the US and internationally, who are dedicated to advancing the science of wound healing. We formed the nation’s first wound healing cooperative group consisting of more than 30 centers in the US and worldwide that now conducts entire multi-national clinical trials. In 2015 Serena Group Innovation™ opened a laboratory at Northeastern Ohio Medical School to conduct preclinical studies in wound healing. The research team has filed numerous patents as a result of these efforts.

Biography:

Dr. Entsuah is a Fellow of the American Statistical Association and presently an Executive Director of Late Development Statistics at Merck Research Labs and Head of Research Group 4 (Neuroscience, Respiratory and Immunology areas). Previously, he was an Assistant Vice President of Biostatistics at Wyeth Research Labs (Pfizer). Prior to joining the industry in 1988) he was an Assistant Professor of Biometry at University of Illinois in Chicago. Dr. Entsuah has published extensively both in statistical and clinical journals and has given many presentations over the years. He has led approval of various compounds as the statistical lead and has been an invited seminar presenter at the US FDA.

Abstract:

A longitudinal mixture model for classifying patients into responders and non-responders is established using both likelihood-based and Bayesian approaches. The model takes into consideration responders in the control group. Therefore, it is especially useful in situations where the placebo response is strong. Under our model, a treatment shows evidence of being effective if it increases the proportion of responders or increases the response rate among responders in the treated group compared to the control group. Therefore, the model has flexibility to accommodate different situations. The proposed method is illustrated using simulation and a depression clinical trial dataset for the likelihood-based approach, and the same depression clinical trial dataset for the Bayesian approach. The likelihood-based and Bayesian approaches generated consistent results for the depression trial data. In both the placebo group and the treated group, patients are classified into two components with distinct response rate. The proportion of responders as shown to be significantly higher in the treated group compared to the control group suggesting the treatment paroxetine is effective.

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Biography:

Ayad K Abdul-Ahad continued his speciality training in the UK in Immunology and Oncology after obtaining his medical degree,. He obtained, the PhD, MSC, MRCPath and FRCPath. His areas of interest included Immunotherapy and BMT. Over the past 24 years he worked in the Biopharmaceutical industry, across the US and Europe, during which he built and lead Medical Affairs and Clinical Development in companies, such as Serono, Berlex, Biogen and Astellas. Ayad also pioneered cancer immunotherapy by treating the first ever patient with a therapeutic antibody for cancer. He is regarded as a Medical Leader by the World leading experts in MS

Abstract:

BOTh analyzes daily patient safety on a clinical study. It provides a more accurate reflection of the burden of treatment than current safety methods and facilitate informed treatment selection. Patient-level safety data was utilized to quantify the daily burden of adverse events by severity on a per patient and per day basis, and presented using a chart. Data from two published studies in peripheral neuropathic pain (PNP) and overactive bladder (OAB) were utilized. In the PNP study, the overall BOTh graph showed a difference in AEs in the two treatment groups.The topical TRPV1 agonist group showed an initial peak followed by a rapid decline in AEs per day, due primarily to transient application site reactions.The oral anticonvulsant group, showed a gradual increase, followed by a consistent number of AEs to the the study end. The overall burden (area under the curve) was 61.2 for the oral anticonvulsant and 23.5 for the topical TRPV1 agonist (p<0.0001).The integration of safety and efficacy into the graph allowed the safety burden comparison with the median time to treatment response. In the OAB study, the overall burden were similar between the two groups. An analysis of patients with dry mouth revealed that more patients reported it in the antimuscarinic group p=0.02. BOTh provides visual representation and statistical analyses of the burden of medication in individual patients or subgroups combining tolerability and efficacy. BOTh allows sensitive, clinically relevant analysis than current methods, which show an overall summary not reporting pateints with more than one AE over time.

Biography:

Suyu Liu is an Assistant Professor at the UT MD Anderson Cancer Center. Her current research focuses on the development of novel adaptive designs for clinical trials. Examples include phase I trial designs to find the maximum tolerated dose (MTD), Phase I/II designs to find the recommended dose accounting for both toxicity and efficacy, dose-finding designs that accommodate late-onset toxicities and biomarker-based adaptive designs for targeted therapy development. She has published more than 30 papers in reputed statistical journals and medical journals.

Abstract:

Interval designs are a class of phase I trial designs for which the decision of dose assignment is determined by comparing the observed toxicity rate at the current dose with a pre-specified (toxicity tolerance) interval. If the observed toxicity rate is located within the interval, we retain the current dose; if the observed toxicity rate is greater than the upper boundary of the interval, we deescalate the dose; and if the observed toxicity rate is smaller than the lower boundary of the interval, we escalate the dose. The most critical issue for the interval design is choosing an appropriate interval so that the design has good operating characteristics. By casting dose finding as a Bayesian decision-making problem, we propose new flexible methods to select the interval boundaries so as to minimize the probability of inappropriate dose assignment for patients. We show, both theoretically and numerically, that the resulting optimal interval designs not only have desirable finite- and large-sample properties, but also are particularly easy to implement in practice. Compared to existing designs, the proposed (local) optimal design has comparable average performance, but a lower risk of yielding a poorly performing clinical trial.

Biography:

Michael Bernstein is Vice President of Global Compliance and Risk Management at Clinical Supplies Management, Inc. He is responsible for the oversight of CSM's global compliance, risk management, process excellence and quality programs. He has over 28 years of Compliance experience in the pharmaceutical industry. Prior to joining CSM, he held various R&D, Manufacturing and Global Compliance positions during his 26-years at Merck & Co. Inc.

Abstract:

FDA’s “Paving the Way for Personalized Medicine” reports along with the funding of the Precision Medicine Initiative are changing the clinical drug development landscape in the United States. Drug development stratification has resulted in numerous drugs being developed for small geographically dispersed patient populations with fewer clinical investigators participating in the clinical studies. This creates a challenge for patients who cannot travel long distances to obtain their clinical medication. DtP shipment of clinical trial material is a potential solution that addresses various challenges introduced by the Precision Medicine Initiative. The objective of this paper is to provide guidance and best practices for study sponsors and clinical investigators wanting to utilize the DtP distribution model for their clinical studies. The author reviewed various regulations, guidance documents and case studies pertaining to DtP distribution of clinical trial material and identifies regulatory and compliance considerations when using the DtP distribution model. There are multiple regulations and guidance documents pertaining to clinical studies but none specifically address the DtP distribution model. Sponsors wanting to utilize DtP distribution in their clinical trial must ensure they get proper buy-in from key stakeholders including Principal Investigators, IRB’s, CRO’s and the patients. Sponsors must develop a clear concise investigation plan incorporating DtP distribution language in their regulatory documents. They must have early transparent dialog with regulators and ensure their plan addresses any concerns the regulators may have.

Biography:

C. C. Chu, the Rebecca Q. Morgan endowed chair professor, is a biomaterial scientist/engineer at Cornell University since 1978. Chu is the recipient of the State University of New York Chancellor’s Award for Excellence in Scholarship and Creative Activities in May, 2009. Chu was very recently inducted into the College of Fellow of the American Institute of Medical and Biological Engineering on March 24, 2014. Chu also served on the Biology/Medicine Panel of the Hong Kong Research Grant Council from 2010 – 2013. Chu has 200 research papers/book chapters, 3 books and 68 US/international patents with 7,665 citations and h-index 50.

Abstract:

A mast cell stabilizer (Ketotifen, KF) doped new biodegradable nano-fibrous membrane fabricated from a new synthetic amino acid-based poly(ester amides) (AA-PEA) and absorbable polycaprolactone (PCl), and hybrid hydrogels from Arg-PEA/chitosan derivatives were evaluated for wound healing characteristics of a 2^nd degree burn as well as full-thickness excision injury of a porcine model at 7, 14, and 21 days post-injury. The characteristics of the wound treated with the new biomaterials were evaluated in terms of tissue inflammatory responses and scar tissue formation. Wound tissues harvested were histologically evaluated for collagen content, type, mast cell and macrophage. Macrophages in tissue sections were labelled with ionized calcium binding adaptor molecule 1 (IBA1) and DAB as the chromagen. The proportion of type I vs. type III collagen was determined from photomicrographs of Pico Sirius Red stained slides illuminated with circularly polarized light, the ratio of yellow/red pixels to green pixels was determined using Fiji. Assay data were analyzed using ANOVA and appropriate post hoc tests for potential differences in time and/or treatment effects on wound HP content. Treatment of burns with the mast cell stabilizer-doped nano-fibrous membrane resulted in a lower wound hydroxyproline content than undoped membrane- or Silvadene-treated wounds, suggesting that the membranes themselves did not invoke a significant inflammatory reaction. Both IBA-1 and positive pixel count data of macrophage confirm that the KF-doped nanofibrous membranes showed lower numbers of macrophage (i.e., inflammation) than both the non-doped and Silvadent-treated burn wounds. There were no statistically significant differences in HP content between excision-wounded untreated and wounded hydrogel-treated groups, suggesting that the Arg-PEA hybrid gels did not induce significant inflammation.

Biography:

Joe Martinez serves as the CEO of Center Point Clinical Services. He brings over 30 years of successful leadership experience in the pharmaceutical, biotech and Medicaid industries. He instituted novel industry programs utilizing RWE (real world evidence) and health outcomes information to communicate product value information to health care decision-makers. His research abstracts and poster presentations have been accepted by national and international associations including ADA, ASCP, AMCP, AGS, AADE and AACE.

Abstract:

Successful clinical trials are critical to compiling the medical and clinical data that are required for FDA review and approval of a drug, device or procedure application. Frequently cited problems that have a direct impact on these clinical trials are patient enrollment, patient medication compliance and patient retention. When these retention issues prolong a clinical study, each extra day can cost a company $37,000 in additional operating costs and $1.1 million in lost revenues according to a Tufts Center for Study of Drug Development Impact Report. Observing a series of four clinical studies completed for one chronic disease (diabetes) medication where pharmacist medication counseling services were provided: 92.8% (2,900 of 3,124) of patients had at least one intervention, 991 (31.7%) patients had a concurrent medication usage intervention. Patients responding to a survey about their satisfaction and their interactions with the pharmacist over the phone indicated: 94.7% of respondents either strongly agreed or agreed that phone conversations with the pharmacist helped them to further understand how to use the study medication, 90.0% of respondents either strongly agreed or agreed that they appreciated the follow-up phone call from the pharmacist due to a missed dose or issues with the IVRS, and 96.3% of respondents either strongly agreed or agreed that they were more comfortable with participating in the trial knowing that a pharmacist was available to answer questions. Pharmacist medication counseling in clinical trials can provide positive strategic clinical support and is well received by the patients.

Biography:

Jody M Ehrhardt is a certified clinical research coordinator with over 20 years of experience in the clinical research industry. Throughout her career she has worked in phase I-IV human trials as a clinical research coordinator, data coordinator, project manager, and Director of Research Services. She also consults for a major animal pharmaceutical company as a regulatory and development specialist. In 2012 she used the experience she gained from working in numerous roles, therapies and industries and founded her own clinical research facility.

Abstract:

According to Tufts CSDD, two-thirds of investigative sites fail to meet the patient enrollment requirements for a given clinical trial. And, whereas in 2001 nearly half of all patients screened for clinical trials completed them, in 2010 less than one in four screened patients were retained for the duration of the clinical trial. In light of this decline more sponsors are shifting their investigator recruitment focus to sites with proven patient recruitment and retention plans. If a clinical research site plans to grow and stay relevant a change in patient recruitment and retention planning that is aligned to how patients receive information and feel about clinical trials in mandatory. Successful research sites need to create and implement a strategy that combines social media, technology, subject needs and wants, and open communication while maintaining medical and protocol requirements. A successful strategy must also include every member of the research team in order to reach maximum effectiveness. And, site staff must realize that an integral member of this team is the trial volunteer.

Biography:

Tamera Norton Smith has twenty-six years of experience investigating and auditing severe GCP noncompliance. She began her career in GCP and GMP environments in 1990 with the USFDA's Atlanta and Buffalo Districts. Her passion for FDA's mission led her to found her own business in 1999 to audit independently and teach responsible research conduct and ethical research practices. She founded Norton Audits in 1999. It was founded on the sole principle that research participants and patients should be safe and protected while vital and effective products are investigated with complete and accurate results and outcomes.

Abstract:

Clinical research misconduct and fraud continues to impact solid research efforts and increases human research participate risks while participating in vital research efforts. Clinical research professionals need a scientific and valid approach to investigating reports of scientific and medical misconduct and fraud. Join with us as we present the ethical code of conduct for identifying, investigating, resolving and reporting of misconduct and fraud occurrences. The instructor has twenty-six years of experience investigating and auditing misconduct and fraud cases. Case studies will be used to demonstrated time proven skills and techniques for the prevention of misconduct.

Biography:

Jennifer Miller currently serves as President of Bioethics International, a nonprofit organization focused on the ethics, trustworthiness and governance of healthcare innovation, focusing on how medicines, vaccines and health technologies are researched, developed, marketed, and made globally accessible. She was previously a fellow in Harvard University’s Edmond J Safra Center for Ethics from 2012-2015. She also taught at Duke University, Fordham University and Columbia University. She holds a BS from Fordham University, a Doctorate in Bioethics from the Pontifical System, a Post-doctorate in institutional corruption from Harvard University, and completed a fellowship in regulatory governance at Duke University.

Abstract:

The Good Pharma Scorecard is a reform strategy that ranks new medicines, biologics and devices and their manufacturers on key integrity indicators, beginning with clinical trial transparency. The pilot index, published in 2015, ranks the transparency of all new medicines and vaccines approved by the FDA in 2012 that were manufactured by the 20 largest companies-342 clinical trials involving 99,599 research subjects. We reviewed these trials, drugs and companies on two sets of standards: 1. The ethical standard that all clinical trials and trial results should be publicly accessible, and 2. The legal standards for trial transparency enshrined in the US Food and Drug Amendments Act (FDAAA). We considered trial information publicly accessible if the trial was registered, reported results in a trial registry, was published in the medical literature and complied with transparency laws. Up until this point, transparency practices have never before been aggregated on the drug level nor assessed by both ethics and legal standards. We found that public disclosures of clinical trial information vary widely by company. Two companies publicly disclosed all of their clinical trial results and fully complied with legal requirements, for at least one of their drugs approved in 2012. While another disclosed only 20% of trial results and scored 0% on the legal compliance index. Today, trial disclosures for new drugs fall below legal and ethics standards with wide variation in practices among drugs and their sponsors. The GPS has the potential to improve compliance with legal and ethics standards and to support data-driven decision-making.

Biography:

Jill McNair has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at The Center for Information and Study on Clinical Research Participation (CISCRP). In this role, she oversees a team dedicated to helping sponsor companies provide lay language summaries to study volunteers. She also manages the planning, creation, and execution of CISCRP education and outreach programs; development and fundraising; marketing and public relations; and business development. She is passionate about providing education to the public so they can make an informed decision as to whether clinical research is right for them. Working at CISCRP affords her the opportunity to engage patients in the continuum of the clinical research process; whether it’s providing education when they are in a physician’s office or receiving a lay summary after they have given the gift of participation by participating in a study.

Abstract:

Studies consistently show that most clinical trial participants want to know what the research communities learned from their participation, yet most never hear from the sponsor or research site staff at all after a clinical trial has concluded. CISCRP has developed and tested a program to provide study volunteers with the results of their clinical trial. Working through our editorial panel of medical and health communications experts as well as patient advocates, CISCRP “translates” the technical results of clinical trials into scientifically accurate, non-promotional lay summaries written at a validated 6th-8th grade reading level. Prepared in printed, electronic and audio formats to accommodate different learning styles, the summaries are disseminated to volunteers via their investigative site as a way to fulfill researchers’ ethical obligation to return trial results, and demonstrate to volunteers that they are respected as true partners in the clinical research process. This presentation will focus on establishing a standard practice to communicate trial results to study volunteers. We will explore the following:

• How lay language summaries fulfill the ethical obligation to return trial results to participants
• Properly translate study results within lay summaries to ensure accurate return of results
• Establish the need for multiple communication methods to return results
• Develop a standard practice for communicating lay language

Biography:

Abstract:

This presentation concerns a new field covered by low temperature plasmas at atmospheric pressure for medical treatments. This is based on the very attractive possibility to tune and design plasmas as possible pharmaceutical products by using selectively some active species (charged particles, radicals, atomic and molecular agents, UV radiations) and even electric fields self-generated by the plasma. The delivery of active species occurs at the gaseous level. This means that there is no need for a carrier medium and the treatment of living tissue or surface is optimal because plasmas can penetrate small pores, spread over rough surfaces and reach both prokaryotic and eukaryotic cells. The present presentation gives first a review on the main low temperature plasma setups potentially usable for medical treatments with an emphasis on the setups as for instance plasma jets developed in our laboratory. Then, the presentation gives a review of the current state of the art of such plasmas as pharmaceutics products or therapeutic tools in Medicine with a light on a selection of forefront researches particularly in the field of cancer treatment using plasma activated media.

Biography:

Abstract:

Corticotropin releasing factor (CRF) signaling in the posterior ventral tegmental area (pVTA) mediates stress-induced psychostimulant self-administration. Recently, using a Cre-dependent tract-tracing approach with AAV-Flex-ChR2 in adult CRF-Cre male mice, we localized the source of pVTA-CRF to neurons projecting from the lateral hypothalamus (LH) and dorsal raphe nucleus (DRN) synapsing in the paranigral (PN) and parainterfascicular (PIF) sub-nuclei of the ventral posterior medial (VPM) sub-region of the pVTA. We observed that the DRN-, but not the LH-, VPM-CRF circuit was activated after repeated, but not acute, social defeat stress. Furthermore, we found that repeated optical or chemo-genetic activation of CRF in the VPM was sufficient to engender amphetamine (AMPH)-induced-locomotor behavioral cross-sensitization and escalated cocaine intake. Specifically, we observed that male mice with a history of repeated CRF optical or DREADD stimulation in the VPM displayed a significant increase in distance traveled in an open field test after treatment with a low dose of AMPH (1.5 mg./kg.) compared to saline treated and Cre-/- littermate controls. Subsequent cocaine self-administration experiments demonstrated that repeated DREADD CRF activation in the VPM enhanced drug-seeking behavior. Here we build upon these data by focusing on the DRN-VPM CRF microcircuit by using a combination of techniques. Previously, we observed site-specific increases in CRF-ir in the PN/PIF but not the parabrachial pigmented area of the pVTA following stress. Thus, we bilaterally infused CRF-Cre male mice with the G(q) DREADD virus into the DRN and implanted a unilateral microdialysis probe aimed at the PN/PIF and sampled the VPM for CRF during saline and CNO treatment. Our data demonstrate enhanced CRF release in the VPM of DREADD G(q) infected DRN-CRF neurons, after i.p. CNO injection. These results suggest functional increases in released CRF in the VPM after activation of DRN-CRF neurons projecting to the pVTA. We will extend this work by measuring dopamine (DA) release in the nucleus accumbens shell of mice with a history of DRN-VPM CRF microcircuit activity. These latter experiments aim to ascertain mesocorticolimbic CRF-DA interactions and potential increases in rate of cocaine self-administration and reinstatement after abstinence. At present, our data reveal a site-specific CRF microcircuit exclusively projecting from the DRN to the VPM sub-region of the pVTA, its sensitivity to social defeat stress, and VPM-CRF release presumably altering DAergic output in the forebrain after repeated experiences with brief episodes of social stress.

This research was supported by an NIMH R01 research grant NS073574 to J.M., a NIDA grant 031734 to K.M., the Tufts Center for Neuroscience Research grant P30 NS047243, and a Tufts Collaborates grant. The authors declare no biomedical, financial, or potential conflicts of interest. The experiments were approved by the Institutional Animal Care and Use Committee and were conducted in accordance with the National Institutes of Health Guide for the Care and Use of Laboratory Animals.

Biography:

Anvita Karara is a Life Science Professional with expertise in Clinical Trial Design and modeling. She pursued her Masters in Biotechnology and Management from Carnegie Mellon University, USA. She has worked prior in this space with leading bio-pharmaceutical companies such as Genentech (a Roche company) and Onyx Pharmaceutical (an Amgen subsidiary).

Abstract:

The bio-pharmaceutical industry is struggling to optimize the clinical development process and generate a sufficient return on investment. The critical factors that are challenging the operating landscape include: high protocol complexity, long clinical cycle time, rise in development cost and silo-based operating models. These challenges make it difficult to achieve enrollment targets, leading to protocol amendments and rework on the clinical development plan (CDP). Currently the pharmaceutical industry contains fragmented operating models based only on study level enrollment predictions. There is a need to re-engineer these silo-based study level operating models and create an integrated CDP operating model. This integrated program level operating model will capture all CDP scenarios, draft launch labels, target product profiles and estimated cost in a central location. It will enable higher cross-functional collaboration, planning and execution. It also helps the clinical development teams analyze multiple program level scenarios to determine the risk, cost and time tradeoffs. The integrated CDP operating model methodology signifies an innovative approach to re-engineering the current clinical development process. Combining the siloed study level enrollment predictions, enables the business to compare program level scenarios for better decision making. This approach can be an asset for high level clinical planning, boost efficiency, reduce trial spend and serve as a collaborative operating model.

Biography:

Ankit Lodha has high-end expertise in study conduct and interpretation of clinical operations data in the pharmaceutical/ biotechnology industry. He is Analytics Operations Lead in Clinical Application & Analytical Services (CAAS) at Amgen. Within Amgen he has worked on R&D and Commercial Analytics. Before this position he has provided strategic consulting services, supporting the analytics, data reporting and data management needs of senior leadership at AstraZeneca and Pfizer. He holds a Bachelors’ in Biotechnology Engineering from Dr. D.Y. Patil University, Masters in Business of Bioscience from Keck Graduate Institute and MBA from Redlands University – School of Business.

Abstract:

Pharma companies spend millions of dollars on research and even more on these clinical trials to ensure safety and efficacy of the drugs. Developing the right protocols, selecting the proper sites, setting the right expectations with all stakeholders, developing and tracking the right metrics and effective communication is the key to optimizing the resources and cost of clinical trials. The number of clinical trials underway each year has been increasing steadily, worldwide. In the last five years alone, over 75,000 federally and privately supported trials have been registered with the National Institute of Health’s Clinical Trials registry. Conducting clinical trials today is a complex set of activities that amass huge volumes of data from multiple systems. Having real-time clinical metrics and dashboards which provides insights on patient enrollment, study conduct, close-out and reporting is one of the biggest challenges for bio-pharmaceutical R&D industry. With a broad range of study designs, varying data collection methods and time points, efficient data analysis in clinical development has become more important than ever. The more effectively study data are managed, the faster the data can be extracted and analyzed. The analysis of the data is important for each trial stage as valuable insights can be gained. For example, during the early stages of a clinical trial, access to data is vital not only for patient safety, but for solving problems while they are still manageable and before they become costly.

Biography:

Suzanne Bishop is the North American Facilitator for the eClinical Forum, a non-profit global discussion and action group representing members of the pharmaceutical, biotechnology, and allied industries focusing on electronic capture, handling, and submission of clinical data. Recent projects have focused on Electronic Health Records for Clinical Research. She was the project manager of the EHRCR project which resulted in an HL7 and ANSI Standard Functional Profile and a EuroRec-approved profile, and the eSource Readiness Assessment (eSRA) tool. Suzanne holds an MA in Organizational Leadership and a BS in Computer Science and has worked for the past 30 years in the area of software application support for clinical research.

Abstract:

The eClinical Forum – a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, have developed a regulatory-based assessment tool for EHR vendors or sites to determine if their EHR system is appropriate to hold regulated clinical trial data. This tool will help make the clinical research process more efficient, while furthering the use of EHR records for clinical research. It is offered free; there are no advertisements on the website and your information will not be used for other purposes. The eClinical Forum’s only intent is to make the process more efficient for everyone. Through the use of the eSource Readiness Assessment Tool (eSRA), EHR vendors can provide information to their customers who do clinical research, to help these clinical research sites determine if they are meeting regulations. The clinical research sites are already being asked these questions by their clinical research sponsors (pharmaceutical companies) and it can be timely to complete a different form for each research sponsor. By using the eClinical Forum tool, the site can complete just one assessment and give it to each of their sponsors. We have already shown this tool to regulators and had a favorable response – some are even presenting it at industry conferences. The more EHR vendors that participate, the easier it is for their sites to participate, and the more sites that participate, the easier it is for their sponsors to participate. If everyone uses this assessment form then it really does become a highly efficient way to gather the information that regulators want – information that shows that the systems that may originate data that could end up in a clinical trial has integrity.

Biography:

Marina M J Romero-Prado has completed his PhD from Autonomous University of Madrid (UAM), Spain. She is a Molecular Biologist, Geneticist and works as a Professor and Director of a research team focused on pharmacogenetics of complex metabolic diseases at the Experimental and Clinical Therapeutics Institute in CUCS, University of Guadalajara. She has published her discoveries in expression regulation of growth hormone gene and molecular and cellular research about biological potential of mesenchymal stem cells. Her incursion as leader in clinical protocols has served to bind the basic and applied research in complementary medicine. 

Abstract:

Introduction: Previously we have shown that dietary flavonoids (DF) administrated to antihypertensive pharmacological therapy (AHT) have additional benefits on blood pressure, lipid profile, inflammation and obesity in hypertensive young people. In the present work, we compared the efficacy of this approach with DF on electrocardiography parameters on both gender patients from 20 to 50 years.

Material & Methods: 37 male and 42 female patients with hypertension grade I (n=27) or II (n=52) received 425.8±13.9 mg gallic acid equivalents (GAE) from dietary flavonoids were added to AHT based on captopril (50 mg/day) or telmisartan (40 mg/day) during 6 months. The standard electrocardiogram (ECG) 12-lead was recorded at 25 mm/s and 1 mV/cm measured at 0, 3 and 6 months of treatment. The ECGs criteria was: The Cornell voltage combination (CV)=(RaVL+SV3); the Cornell product (CP), considered as the product of QRS duration times the CV. The media changes between base line to the end of the study were considered as significant at P<0.05.

Results: By gender, the SBP diminution was significantly lower in women with AHT+DF vs. AHT (−40.5±8.4 vs. −30.65±9.2 mm Hg) (P=0.002). DBP reduction was different in women with ATH (−18.3±8.4 mm Hg) vs. ATH+DF (−20.6±5.1 mm Hg) (P=0.049); while men with AHT showed (−17.9±4.6) vs. ATH+DF (−21±5) (P=0.03).

Conclusion: By gender, male were the most favored than women in the CP diminution, so the response to DF added to AHT in BP and ECG parameters depends on patient’s gender.

Biography:

Joe Martinez serves as the CEO of Center Point Clinical Services. He brings over 30 years of successful leadership experience in the pharmaceutical, biotech and Medicaid industries. He instituted novel industry programs utilizing RWE (real world evidence) and health outcomes information to communicate product value information to health care decision-makers. His research abstracts and poster presentations have been accepted by national and international associations including ADA, ASCP, AMCP, AGS, AADE and AACE.

Abstract:

Currently, ‘patient-centricity’ has gathered visibility and momentum in the media, in the clinical industry and with regulatory authorities as a way to improve trial enrollment, patient retention and study outcomes. Many clinical trials must plan to over-enroll because according to a Tufts Study, 37% of sites under enroll, while 11% do not enroll even one patient. Patient-centricity has become known as “Direct-to-Patient” (DtP) when being discussed as part of a clinical trial protocol. While DtP places the patient at the center of the research process, it engages the patient more directly and can also address geographical challenges in trial operations and logistics. Important items to consider when successfully incorporating DtP into your next clinical trial include: Regulatory Considerations – Policies and acceptable processes vary by country and it’s advisable to begin a dialogue with the appropriate regulatory authority early in the trial planning process. Good Clinical Practices – Clear investigation plan to address the specifics of DtP, and considering a hybrid approach with an option to ‘opt out’. Privacy Laws – Understanding and appropriate guidance to comply with local and global data protection laws. Good Distribution Practices – Well-documented supply chain and processes to ensure chain of custody. Future trials will include a DtP component to address ongoing challenges of patient enrollment, retention, compliance and outcomes. In addition, a decreased number of study sites may provide added benefits of decreased trial costs, increased operational efficiency and enhanced data collection.

Biography:

Songul Cetik is an Assistant Professor at Vocational Higher of Health Services, Mardin Artuklu University in Turkey. She has completed her graduation from Eskisehir Osmangazi University, Faculty of Arts and Sciences, Department of Biology, 2009. She has done her Post-graduation from Eskisehir Osmangazi University, Faculty of Science, 2014. 

Abstract:

Cardiotoxicity is one of the limiting side effects of this commonly used anticancer agent and cardio toxic effects of cyclophosphamide (CP) were found to be dose-related cardiac damage, morphologically defined as necrosis and bleeding. Hypericum triquetrifolium Turra (HT) has a phenolic component with anti-oxidative and anticarciogenic properties. This study aimed to investigate the possible protective effect of HT on CP-induced cardiotoxicity. Serum aspartate transaminase (AST), alanine transaminase (ALT), lactate dehydrogenase (LDH), malondialdehyde (MDA), creatine kinase-MB (CK-MB), total oxidant state (TOS), total antioxidant state (TAS) and oxidative stress index (OSI) were examined. Furthermore, the cardiac tissues were analyzed histologically. Albino rats (Wistar, 3-4 months old, male, weight 220±20 g healthy) were randomly divided into 9 groups, each including 7 animals: Group 1 (control) treated with 0.5 ml saline; Group 2 treated with 150 mg/kg CP; GroupS 3, 4 and 5 treated with 25, 50 and 100 mg/kg HT respectively; Groups 6, 7 and 8 treated with 25, 50 or 100 mg/kg HT+CP respectively; and Group 9 treated with 0.5 ml-0.2% DMSO. The results were analyzed by one way analysis of variance and Kruskal-Wallis one way analysis of variance on ranks test. Levels of AST, ALT, LDH, MDA, CK-MB, TOS and OSI were found high only in the CP groups. GSH and TAS levels were found low in the only CP groups. It was also observed that CP-induced cardiotoxicity was dose dependent. Hemorrhage, inflammatory cell infiltration and the separation of the muscle fibers in the heart tissue supported the biochemical data. With 25, 50, 100 mg/kg HT, there was an significant decrease in the CP toxicity; reduced inflammation and lipid peroxidation in the heart tissue and increase of serum glutathione (GSH) and total antioxidant capacity (TAS) levels were found when HT was applied. Based on these findings, it can be proposed that HT was a strong candidate in preventing the CP-induced cardiotoxicity but further clinical studies need be done in order to verify its application on humans. 

Biography:

Nicola Stagg has completed her PhD in Pharmacology and Toxicology from University of Arizona. She is a DABT Toxicologist in Drug Development with more than 8 years experience as a Nonclinical Toxicologist designing GLP and non-GLP toxicology studies, interpreting data, conducting mechanistic studies, submitting regulatory documents and presenting to regulatory agencies globally. She serves as a Lead Toxicologist for several antibody drug conjugate and large molecule oncology programs at Genentech. She has worked on over 20 different drug development programs. She is the author of 11 peer-reviewed journal articles, 2 patents and over 15 published abstracts. 

Abstract:

Antibody drug conjugates (ADC) consist of potent cytotoxic drugs conjugated to antibodies via chemical linkers, which enables specific targeting of tumor cells while reducing systemic exposure to the cytotoxic drug to improve the therapeutic window of chemotherapy drugs. The valine citrulline monomethyl auristatin E (vcMMAE) ADC platform (conventional linker-drug conjugation) has shown promising clinical activity in a variety of cancers, but peripheral neuropathy (PN) has been observed in the clinic but not in nonclinical toxicology studies. We evaluated four possible hypotheses for the lack of translatability of PN in nonclinical toxicology studies with conventional vcMMAE ADCs: 1) exposure differences; 2) sensitivity of the animal model; 3) differences in how ADC properties manifest; and 4) susceptibility of clinical population. The result of this hypothesis-based approach identified several challenges with trying to model the PN observed in late stage oncology patients in our nonclinical toxicology studies with MTI containing ADCs due to a combination of factors related to all four hypotheses. However, it also enabled us to more systematically determine if a better in vivo animal model could be employed to improve translatability. While many data gaps still remain; increasing duration of exposure and incorporating an expanded neurohistopathology assessment of peripheral nerves in our nonclinical toxicology studies may enable us to reproduce the PN observed with conventional vcMMAE ADCs. The ultimate goal is to be able to have a model to screen the next generation MTI-ADCs for reduced incidence and severity of peripheral neuropathy. 

Biography:

Dr. Elena Landoni has completed his PhD at the age of 28 years from University of Milan and works as biostatistician at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan. Her research involves the application of machine learning methods for the analysis of high-dimensional ‘omics’ data. In particular, she is focused on the discovery and development of cancer molecular biomarkers, with implementation of feature selection algorithms together with the use of original and simple graphical representations of the results. Another area of her interests is nonparametric statistics, applied in particular to the fields of molecular biology and personalized medicine.

Abstract:

Background: Plasma miRNAs have the potential as cancer biomarkers but no consolidated guidelines for data mining in this field are available. The purpose of the study was to apply a supervised data analysis strategy in a context where prior knowledge is available, i.e. that of hemolysis-related miRNAs deregulation, so as to compare our results with existing evidence.

Results: We developed a structured strategy with innovative applications of existing bioinformatics methods for supervised analyses including: 1) the combination of two statistical (t- and Anderson-Darling) test results to detect miRNAs with significant fold change or general distributional differences in class comparison, which could reveal hidden differential biological processes worth to be considered for building predictive tools; and 2) a bootstrap selection procedure together with machine learning techniques in class prediction to guarantee the transferability of results and explore the interconnections among the selected miRNAs, which is important for highlighting their inherent biological dependences. The strategy was applied to develop a classifier for discriminating between hemolyzed and non hemolyzed plasma samples, defined according to a recently published hemolysis score. We identified five miRNAs with increased expression in hemolyzed plasma samples (miR-486-5p, miR-92a, miR-451, miR-16, and miR-22).

Conclusions: We identified four miRNAs previously reported in the literature as hemolysis related together with a new one (miR-22) which needs further investigations. Our findings confirm the validity of the proposed strategy and, in parallel, the hemolysis score capability to be used as pre-analytic hemolysis detector. R codes for implementing the approaches are provided.

Biography:

Abdoul Habib BEAVOGUI has completed his PhD at the in 2010 from Claude Bernard University in Lyon, France before returning to Guinea to set up a clinical research team at Maferinyah. He is the director of Maferinyah Training and Research Center in Rural Health, a public institution. He has participated to three clinical trials on Ebola in Guinea published more than 20 papers in reputed journals.

Abstract:

This study report on a portfolio of clinical research conducted in Guinea during the Ebola epidemic and draw the lessons learnt for the future from our perspective as Guinean medical researchers. We conducted a qualitative review of clinical research conducted in Guinea from June 2014 to July 2015, with a focus on vaccine and treatment studies. We also met with key stakeholders to discuss their views on the lessons learnt. Between June 2014 and July 2015, there was an increase in clinical research activities in Guinea. Three main types of clinical studies were undertaken during this period in Guinea: treatment studies (5 studies), vaccine studies (2 studies) rapid diagnosis test studies (9 studies) and natural history cohort studies (3 studies). Randomization was only possible in the WHO sponsored vaccine trial and with the JIKIMAPP trial (NIH/INSERM sponsored trial). The remaining trials (JIKI trial, Ebola_Tx trial and Interferon trial) used historical controls at their study sites for comparisons. Strong political will enabled a supportive environment for clinical research. Good complementarity between ethics and regulatory bodies reduced delays in the review processes for research consortia and communities (survivors for instance) were strongly involved in the research projects. The challenges included incorrect communication at the beginning of the outbreak, lack of proven treatment for Ebola, the debate about randomization, the high number of infections among health care workers, the lack of qualified human resources and sociocultural barriers and stigmatization against Ebola survivors along with governance issues.

Biography:

Abstract:

Subject recruitment and retention in clinical studies are identified as major barriers to finishing clinical studies in a timely manner. Soaring drug development costs mean that each day a drug is delayed from reaching the market, sponsors are losing as much as $8M per day. Sponsors must find ways to save time in order to extend drug exclusivity. Using investigative sites in CEE for phase 1b to phase 4 clinical studies can ensure that studies are completed on time or ahead of time. Many sponsors are hesitant to use sites in CEE because they do not understand how to get predictable results, or because they have biases against anything outside of the US or Western Europe. This is known as the “streetlight effect.” As a result, less than 2% of all clinical studies take place in CEE. The goal of my presentation is to take out the mystery of conducting studies in CEE. I will describe the healthcare system, centralized medicine, which funnels patients into relatively few sites and encourages patient retention. I will explain why patients in CEE are eager to participate in clinical studies. I will explain why physicians are motivated to be the top enrolling sites. I will cover why the data from these sites is higher quality than data from other geographies. Finally, I will explain that while study-startup times are somewhat longer, they are predictable (unlike other geographies).

Biography:

Mohammadreza Sattari has completed his PhD from the School of Medicine of Cardiff University in the UK. He is a Clinical Toxicologist, Professor and Director of a research team focusing on clinical trials and bioequivalence studies at the Faculty of Pharmacy and hospitals of Tabriz University of Medical Sciences. He has published more than 50 papers in reputed journals and serving as an Editorial Board Member of repute.

Abstract:

The aim of the present study was to determine the concentrations of nitroglycerin(glyceryl trinitrate, GTN, CAS 55-63-0) and its two main stable metabolites;1,2-dinitroglycerin (1,2-glyceryl dinitrate, GDN, CAS 621-65-8) and 1,3-dinitroglycerin(1,3-GDN, CAS 623-87-0) in human plasma using a capillary gas chromatography method with an electron capture detection. Using the GC conditions, linear calibrations were obtained for 1,3-GDN from 0.14 to 3 ng/mL, for 1,2-GDN from 0.06 to 6 ng/mL, and for GTN from 0.01 to0.3 ng/mL in plasma samples by the following calibration curve equations:[y=0.1924x–0.0088 (r2=0.999)],[y=0.2273x+0.0164 (r2=0.995)],[y=17.434x–0.0751] for 1,3-GDN, 1,2-GDN, and GTN respectively. The calculated limits of quantification values for GTN, 1,2-GDN, and 1,3-GDN were 0.03 ng/mL, 0.2 ng/mL, and 0.15 ng/mL respectively. This method was verified with a bioequivalence study of an Iranian brand of oral sustained release nitroglycerin with an innovator formulation.

Biography:

Hetal Shah is a Pharmacologist with over 12 years of first-hand experience in the field of Medical Writing and Clinical Research Project Management. She is a Gold medalist and a PhD holder awarded by the Gujarat University. She has 20 odd publications to her credit including book chapters, research papers and review articles in national as well as international journals. She is a medical writing expert with high standards for quality and work ethics. She is extensively involved in developing scientific and regulatory documentation and publications for various international and national Pharmaceuticals & CROs. She is also an experienced trainer with practical approach to coaching, and conducts medical writing workshops customized for various topics and audiences’ needs. She is a member of the executive committee of All India Medical Writers Association (AIMWA) and the DIA Medical Writing Group of India.

Abstract:

Medical writing has now evolved from being a sub-specialty service to a full-fledged line of business in the Healthcare Industry. A lucrative career option in itself, medical writing offers avenues not only as individual contributors, but also leadership and managerial positions. While, typically, medical writers develop documents individually or as a team, it would be worth extrapolating and comparing medical writing as an operation and treating each assignment as a project. With this, principles of project management usually applied to operational scenario can also be implemented to Medical writing profile and projects to further ease out and systematize the medical writing as a function. In medical writing, it is estimated that while 60% of a writer’s job is actually writing, 40% is project management. Hence, besides being technically equipped to execute the core activity i.e. draft the required document, project management skills are also desired in a medical writer. Project management is the application of knowledge, skills and techniques to execute projects effectively and efficiently. The concept of project management revolves around balancing The Triple constraints – Time, Scope, Cost; keeping Quality as the core. The discipline of project management is about providing the tools and techniques that enable the project team to organize their work to meet these constraints. Project management processes falls into five categories – Initiation, Planning & Design, Executing, Monitoring and Controlling, and Close-out. This presentation shall describe the extrapolation of project management concepts to Medical Writing as a function, and involve discussion on each aspect of project lifecycle in lines of a medical writing project, and a step-wise schedule of events/activities for handling a medical writing assignment from initiation to close.

Biography:

Nazila Bazrafshan has completed her M.Sc. in industrial engineering at Yazd University, Iran, in 2015. Her research interests are cancer treatment planning and medical decision-making.

Abstract:

Clinical trials play an increasingly important role in determining how treatment regimens are effective and safe. Treatment trials are the most common type of trials aimed at finding the best treatments causing the minimal side effects. They serve as a standard technique for evaluating chemotherapy treatment plans used to improve cancer treatment and care. Adaptive trials, on the other hand, test sequential treatments to select the appropriate treatment regimen in accordance with the patient’s condition. In fact, the intensity of advising the treatment regimen varies in response to the patient’s needs. We propose such a design using a Markov decision process (MDP) model for selecting the optimal policy of cancer chemotherapy treatment regimen according to the patient’s condition. The developed MDP model employs novel optimal cancer chemotherapy treatment regimens resulted from an optimization model which relies on previously published clinical trials. In this way, the MDP model benefits from the results of optimization model which propose the most-promising and cost-effective new chemotherapy combinations. Hence, the proposed approach takes the impact of the patient’s response to the treatment regimen into account and proposes the most-promising dynamic treatment regimens also costing reasonable. Results show that the proposed approach yields the optimal sequence of chemotherapy treatment regimens for a period of chemotherapy treatment which makes possible designing clinical trials for sequential treatments. Comparing to the existing implemented clinical trials, we show that our proposed design significantly improves both health outcomes and treatment costs of patients.

Biography:

Deepti Goel is M.Pharm (Pharmacology) and certified PMP (from world renowned institute, PMI International) by training with over 15 years of experience in Clinical Research specializing in the areas of Project Management and sponsor liasoning, People Management, GCP and regulatory training, S i t e training and development, SOPs creation and up gradation, GCP-Audits of sites.

Abstract:

A clinical trial site is an epicenter of clinical research, as the core action of clinical research in terms of subject screening, recruitment, retention, medical care and data entry etc. happens here. Alone a site can achieve nothing if not partnered by a committed, experienced and quality cautious investigator. But natural, they are the biggest stakeholders and success of any clinical trial rests heavily on them. Time and again sponsors and Clinical Research Organizations (CROs) have tried and used various parameters to assess and evaluate a site. These parameters have been subjective, objective, and pragmatic. With effect from the year 2013, Indian regulatory law, Schedule Y has enhanced the roles and responsibilities of Investigators and Institution's watchdog, i.e. Ethics Committee, which in turn has made a ‘‘site’’ more accountable. It is evident that the key stakeholders, e.g. sponsors, CROs, and regulators, are looking for objective data to support decisions like, which sites are the best and serve as long-term partners. After all, relationship between a sponsor and a site/investigator, if turns out be a win–win, goes a long way. It is imperative that site identifies its core action points, monitors its performance and improve. Having spent considerable years at sponsors/CROs and sites, author strongly believes that some data points need to be identified to assess site’s quality and functionality. We have attempted to lay down some practical yet important top metrics (data points), site should focus on as part of their own continuous improvement initiatives and also help decision makers like sponsor/CROs to get the right results by choosing the right clinical site.

Biography:

Dr. Mistry is working as a Head Quality Assurance at Ahmadabad and Vadodara for BA/BE and Clinical Trials. He is doctorate in Chemistry and also Post Graduate Diploma in Export Import Management with International Finance. Mr. Mistry has over more than 15 years of experience in the area of Quality Systems applied in Pharmacology as BA & BE studies, Clinical Trials (Phase I to Phase III), R&D scales batches, Bioanalytical research (in vivo analysis), Analytical research (In vitro analysis), Formulation and Development for new drug enlargement in the line with GxPs Like GLP, GCP, cGMP etc. Dr..Mistry joined Accutest Research Laboratories as a Head Quality Assurance in 2006. He was previously associated with several reputed CROs and Pharma Companies like Lambda Therapeutics Ltd, BA research India, Alembic Ltd., Cadila Pharmaceuticals Ltd. He is also engage with Gujarat University for Clinical Research courses as a visiting faculty which is a joint venture with GSBTM and Gujarat University.

Abstract:

It has been observed many times despite of quality system, clinical research division and organization suffering with major non compliance and critical observation from regulatory agency/Vendor. Management supposes to add more quality persons as a investment towards improvement of quality. More often there are several reason for failure to build up quality system like people selection, audit style, chronicle negligence, qualification of auditors, personal behavior, more adage procedures etc. However there are remedies to improve the discussed reason. People selection play major role as the selected auditor will be part of organization. Audit style can be evaluated and make changes to improve and audit as per requirement. Positive team building can add value but be conscious about right role assignment for QA towards the user department. Some of chronic negligence affects the quality with unattended area. Improve the same periodic review of process add advantage as a self inspection. Qualification is must required as per the requirement of role which will be assigning to the auditor, experience can be superseded qualification but minimum qualification should be as rule. Behavioral issues can lead the bad or good culture vice versa with different auditor and user department and add or reduce value in team building. So it can be conclude that there are reasons for failure of quality system but with proper evaluation and handling it can be converting in good quality system.

Biography:

Jasser Alzhrani has completed his Master degree at the age of 29 years from Boonshoft School of Medicine, Wright State University. He is the manager of Drug Information Center, KSMC, Ministry of Health, KSA.

Abstract:

The ClinicalTrials.gov web site supply an appropriate link to look up any study results, however quantitative analyses’ format cannot be downloaded. Thus the purpose is to directly download study results from this web site and provides a link to retrieve all of the results in a sheet format in order to be analyzed properly and by analyzing them, then we describe the clinical trial activity in the Arabian Peninsula. An expert validated the outcome classification algorithms that we used in this against classification. We created databases of the study results ready for analysis by identifying the studies by intervention, population, or outcome of interest. However, this study is simply based upon the information that is in ClinicalTrials.gov. Therefore, our conclusion is that expanding the usefulness of the ClinicalTrials.gov registry by having a database ready for analysis. The benefit from doing this is increases the speed of comparative research.

Biography:

Mr Anwar has been working as researcher and clinical trial coordinator at Mekelle University and Addis abab univerisyt in Ethiopia. For the last three years he was working in one of the largest clinicla trial, Folate project, in addis ababa univeristy which was under collaborational support from Masachuseetes General Hospital, USA. Currently, I am a PhD fellow at universiyt of south australia and working with gene-environmental interaction.

Abstract:

There is a developing consensus on the effectiveness of various interventions for mental disorders in low and middle income countries, and it has been proposed that the main task that remains is to scale up these interventions. In this context we aimed to look at the quality and extent of intervention trials for selected priority mental and neurological disorders in sub-Saharan Africa. We used Medline databases. Randomized or non randomized clinical trials for the treatment of schizophrenia, depression, maternal depression, bipolar disorder and epilepsy/seizure disorders that involve pharmacotherapy, psychotherapy and physical therapy were included. An extensive list of search terms that identified locations, disorders, interventions and study types were employed. The qualities of the trials were appraised using the single component quality assessment of the CONSORT-statement and the Jadad scale. From 1136 studies identified, only 34 trials that fulfilled inclusion criteria were used for quality analysis. Most studies were clinical trials of treatments for epilepsy and conducted after 2006. In terms of region, the majority of studies were conducted in South Africa (22 of the 34). Pharmacotherapeutic interventions (71%), and conducted at a single center (53%) predominated. In terms of methodological quality in relation to the Jadad scale, 82% fulfill criteria for good methodological quality with a score of 3-5. However, the methodological quality according to the CONSORT criteria was more mixed. The overall quality of clinical trials conducted in Sub-Saharan Africa is encouraging despite the limited number. However, important quality limitations remain and have not improved over time. Establishing clinical trial centers in these countries may be one approach to improve quality and quantity of trials.

Biography:

Azza Saleh RADWAN is a Prof. of Clin. and Chem. Path. at TBRI, she is delegated as Head of the Central Directorate for Research and Health Development (RHD) in MoHPH, she is holding Diploma in TQM in Healthcare from AUC and certified as an International Trainer in Research Ethics from USA. She is the Coordinator of the National REC and the Higher REC. She is the Vice Chair of Aswan Heart Center - Magdy Yacoub Foundation REC, Air Force Specialized Hospital IRB and AFCM- IRB, she is a Faculty member in the Armed Medical School for Research and Medical Ethics.

Abstract:

Clinical trials are widely conducted in Egypt and all of them get approval from the National Research Ethics Committee affiliated to the Egyptian Ministry of Health and Population (MoHP-REC). This committee has been created by a ministerial decree in 2007 and has been renewed several times lately in April 2015, it reviewed all clinical trials conducted in Egypt before their start and follow them through progress report every 3 months. Our National REC has FWA 00016183.

Biography:

Moustafa Abdou Elsyad has completed his PhD at the age of 31 years from Mansoura University and postdoctoral studies from Faculty of Dentistry, Mansoura University, Mansoura, Egypt. He is An Associate Professor, of Removable Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt. He has published more than 18 papers in reputed journals and has been serving as a reviewer in reputed journals of high impact factor in the field of implant prosthodontics .

Abstract:

This study aimed to compare the influence of resilient liner and clip attachments for bar-implant retained mandibular overdentures on opposing maxillary ridge after 5 years of denture wearing. Thirty edentulous male patients received 2 implants in the anterior mandible after being allocated into 2 equal groups using balanced randomization. After 3 months, implants were connected with resilient bars. New maxillary complete dentures were then constructed and mandibular overdentures were retained to the bars with either clips (group I, GI) or silicone resilient liners (group II, GII). The prosthetic and soft tissue complications of the maxillary dentures were recorded 6 months (T6m), 1 year (T1), 3 years (T3) and 5 years (T5) after overdenture insertion. Traced rotational tomograms were used for measurements of maxillary alveolar bone loss (R). Change in R immediately before (T0) and after 5 years (T5) of overdenture insertion was calculated. Maxillary denture relining times and frequency of flabby anterior maxillary ridge occurred significantly more often in GI compared to GII. The change of R in anterior part of maxilla was significantly higher than change of R in posterior part in both groups. GI showed significant resorption of anterior residual ridge compared to GII. Relining times and frequencies of flabby ridge were significantly correlated with change in R. Within the limitations of this study, resilient liner attachments for bar-implant retained mandibular overdentures are associated with decreased resorption and flabbiness of maxillary anterior residual ridge and fewer maxillary denture relining times when compared to clip attachments.

Biography:

Tamera Norton Smith has twenty-six years of experience investigating and auditing severe GCP noncompliance. Tamera began her career in GCP and GMP environments in 1990 with the USFDA's Atlanta and Buffalo Districts. Her passion for FDA's mission led her to found her own business in 1999 to audit independently and teach responsible research conduct and ethical research practices. She founded Norton Audits in 1999. Norton was founded on the sole principle that research participants and patients should be safe and protected while vital and effective products are investigated with complete and accurate results and outcomes. Norton Audits provides independent facts for transparent decisions for GCPs.

Abstract:

Clinical research misconduct and fraud continues to impact solid research efforts and increases human research participate risks while participating in vital research efforts. Clinical research professionals continue to need knowledge, skills and prevention and detection skills to eliminate negative compliance outcomes. Every research professional has roles and responsibilities to care for those that participate. Every research professional has roles and responsibilities to ensure proper results are reported for key decisions on study results. Join with us as we dissect recent cases of scientific and medical misconduct and fraud. The instructor has twenty-six years of experience investigating and auditing misconduct and fraud cases. Case studies will be used to demonstrated time proven skills and techniques for the prevention of misconduct. Workshop Objectives: Attendees will be able to: 1. Apply legal standards to various types and forms of noncompliance to Good Clinical Practice (GCP) including domestic and international laws, regulations and guidance required by various governments. 2. Dissect misconduct and fraud cases for examples of both types and forms of misconduct and fraud. 3. Compare and contrast misconduct and fraud case studies. 4. Compare and contrast scientific and medical misconduct case studies. 5. Discern the similarities and differences in investigator and sponsor misconduct and fraud. 6. Apply proven monitoring and auditing skills and techniques used to prevent and detect misconduct and fraud. a. Skills and techniques i. Understanding Protocol ii. Data-Driven Trend Analysis iii. Risk-Based Approaches and Planning iv. Monitoring and Auditing Source and Data Skills and Techniques 7. Implement risk-based concepts and procedures to ensure risk mitigations and prompt identification for nonconforming performance and risk indicators.

Biography:

Stephen Hsu earned a PhD degree from the University of Cincinnati. He spent four years at Memorial Sloan-Kettering Cancer Center prior to a 4-year career change as a TV sports anchor for ESPN International while taught at the National University of Singapore. He is a tenured Professor at Georgia Regents University and serves as Course Directors for Nutrition and Biochemistry. He published more than 60 research articles and 8 books/book chapters. His contribution in translational studies on the benefits of green tea was recognized with multiple awards such as Georgia Bio Innovation Award and IADR/GSK Innovation in Oral Care Award.
 

Abstract:

Current non-toxic or “generally recognized as safe” (GRAS) countermeasures against viral entry into cells in the human body are often inadequate. The objective of this study was to evaluate a novel alcohol-based instant hand sanitizer formulation containing lipophilic EGCG (derived from green tea extract), in comparison to commonly used hand sanitizers either with or without alcohol. Standard 50% Tissue Culture Infective Dose (TCID50) assay was used for determination of virucidal capacity against poliovirus 1 (PV 1). In addition, neutralization by an ultrafiltration method was used to evaluate the mechanism of virucidal capacity. The results demonstrated that lipophilic EGCG formulations (with and without gelling agent) reduced the TCID50 by a factor of 6 (mean log₁₀–reduction of viral infectivity), 100-fold more than the reduction of viral infectivity (>4 log₁₀) mandated by internationally accepted standards. In addition, the virucidal effect of lipophilic EGCG formulations was associated with direct and irreversible inactivation of PV 1, rather than a reversible inhibition mechanism. In contrast, two commonly used instant hand sanitizers failed to reduce PV 1 viral infectivity by >4 log₁₀. In conclusion, lipophilic EGCG instant hand sanitizer formulations possess effective virucidal capability with the potential for use in novel disinfectant and antiseptic approaches, pending additional research and development.

Biography:

Annalisa Piccorelli received her PhD in Epidemiology and Biostatistics, with a concentration in Biostatistics, from Case Western Reserve University in 2010. Her dissertation work focused on joint modeling longitudinal and time to event data subject to left truncation with applications to cystic fibrosis. After completing her PhD, she has worked at the Cleveland Clinic, the University of Akron and is currently an Assistant Professor of Statistics at the University of Wyoming. In addition to joint modeling, her research interests include prediction models of health outcomes, often displayed with nomograms, clinical trials and mixed models.

Abstract:

During a clinical trial, we may know the results from past patients when assigning new patients to the treatments. It may not be ethical for equal allocation of treatment if we know that one treatment performs better than the other. Response-adaptive randomization methods use the information from past patients to increase the probability of the next patient receiving the better treatment. This paper compares the following three response-adaptive randomization urn designs: Randomized Play-the-Winner (RPW), Modified Play-the-Winner (MPW), and Birth-and-Death Urn (BDUI) with Immigration, to the traditional equal allocation (EA) design. Simulations were conducted to compare the power and allocation of patients to the more effective treatment. For every other sample size 30 to 210, 1000 simulations were run, each with the following three combinations of treatment and control success probabilities: (0.1, 0.3), (0.2, 0.6), and (0.5, 0.7). The allocation proportion increased as sample size increased for MPW for (0.1, 0.3), (0.2, 0.6), and (0.5, 0.7), and for BDUI and RPW for (0.5, 0.7). Because MPW allocated too many to treatment, power could not be assessed. For (0.1, 0.3), (0.2, 0.6), and (0.5, 0.7), power of BDUI, RPW, and EA increased with sample size. MPW tends to be unpredictable and can result in all of the patients being allocated to the better treatment. RPW allocates more patients to the better treatment than BDUI, but BDUI is more consistent in its allocations. The RPW and the BDUI designs produce allocations that have comparable powers to the EA design.

Biography:

João Paulo Tardivo is assistant professor of angiology and vascular surgery and director of the Center for the Treatment of Diabetic Foot in the Faculdade de Medicina do ABC. He graduated in medicine from the Medical School of ABC in 1976 and obtained his Master in Health Sciences in 2004 and PhD in 2013 in the same institution. Expert in vascular surgery since 1979, began his studies with medical lasers in 1987.  In mid- 1999 began to be interested in Photodynamic Therapy in Dermatology and superficial tumors and since 2009 has been doing research with the use of Photodynamic Therapy to treat Diabetic Foot. He has published 14 papers in reputed journals and developed an Algorithm to treat Diabetic Foot with Photodynamic Therapy.

Abstract:

Antibiotic therapy and debridement are the most used practices to manage infectious diabetic foot and usually culminate with some amputation. When infection is associated with vascular disease, the clinical pictures are more serious. The chance of healing without surgical intervention is quite remote. Antibiotics are necessary but diabetic nephropathy is usually present and antibiotics can worsen the clinical condition. It is clearly necessary to develop novel treatment strategies for this health problem. Photodynamic therapy (PDT) is a treatment modality that uses light to generate in situ reactive oxygen species and to cause death in any type of cell including bacteria. Therefore, foot infections can be treated with PDT. Several characteristics of PDT favor it uses to treat diabetic feet: It is a very efficient antimicrobial agent, even against resistant microorganisms avoiding development of resistance; it is applied locally avoiding systemic drug toxicity; it can be applied in outpatient regimens. We performed a clinical study to verify if PDT is an effective method to avoid amputation of infected diabetic feet. An inexpensive PDT protocol was developed and applied to 18 patients with osteomyelitis, classified as Grade 3 on the Wagner scale. Only one of these patients suffered amputation. In the control group, of 16 patients, all of them ended up suffering amputation. The rate of amputation in the PDT group was 0.029 times the rate in the control group and the difference is clearly statistically significant (p=0.002). Another study group with 62 diabetic patients with foot infections allowed the development of the Tardivo algorithm to access amputation risk. Three parameters were more important: Tissue oxygenation, location of infection in the foot and progression of osteomyelitis accessed by Wagner classification. We showed that the combined use of the algorithm and of the low-cost PDT protocol can decrease substantially the amputation frequency in diabetic patients.

Biography:

Saqib Javed has completed his MD (Research thesis) at University of Surrey, U.K. His area of interest is prostate cancer diagnosis and his research focussed on Prostate Histoscanning and Engrailed-2 that is a novel urinary biomarker for prostate cancer. He is currently a Urology Specialist Training Registrar in the Mersey region, Liverpool, U.K. He has published his research work in various peer-reviewed journals and presented at various regional, national and international conferences. He was awarded the best poster award for his presentation on Prostate Histoscanning™ at the European Association of Urology (EAU) conference, Stockholm in 2014. He is also a reviewer for British Journal of Urology International (BJUI) and World Journal of Urology (WJU).

Abstract:

Prostate Histoscanning^TM (PHS) is a trans-rectal ultrasound (TRUS) based technology that scans the prostate gland sequentially using a TRUS probe. PHS software then analyses back-scattered radiofrequency data following the TRUS scan. The manufacturers claim that PHS can distinguish between benign and malignant tissue based on their radiofrequency signature. Initial reports showed encouraging results with PHS. Subsequent studies were unable to reproduce these findings. Various studies were performed comparing PHS with TRUS biopsies, trans-perineal template guided biopsies, whole mount radical prostatectomy specimens and multiparametric magnetic resonant imaging. Initial studies in 2008 (Braeckman et al) and 2012 (Simmons et al) showed encouraging results for PHS in detection of prostate cancer. These studies included small number of highly selected patients and were un-blinded. More recently in 2014 (Javed et al) and 2015 (Porres et al), blinded studies of unselected and higher number of patients were performed in routine clinical practice that showed the inability of PHS to detect prostate cancer. Conclusion: Initial small and un-blinded studies on PHS reported encouraging results. However, subsequent independent and blinded studies with larger patient cohorts did not reproduce these findings and revealed that PHS failed to identify prostate cancer in routine clinical practice.

Biography:

Rimda Wanchoo has completed her Medical Training in Nephrology at Weill Cornell Medical Center and currently is an Assistant Professor of Medicine at Hofstra Northwell School of Medicine in New York, USA. She has published papers in onconephrology and toxicities of chemotherapy agents and their effects on the kidney. She also serves as an expert member for the Cancer and Kidney International Network (C-KIN).

Abstract:

Introduction: Novel targeted anti-cancer therapies have resulted in improvement in patient survival compared to standard chemotherapy. Renal toxicities of these agents are increasingly being recognized.

Aim: We studied the renal adverse events associated with oncologic targeted therapies.

Design: We studied all renal toxicities reported by selected novel targeted therapies to the FDA Adverse Event Reporting System (FAERS) 3^rd quarter of 2011 to 2^nd quarter of 2015. In addition we reviewed published literature and clinical trials to further understanding of renal toxicities with these agents.

Results: The number of adverse events reported was 2,943 during the years 2011-2015. For all agents combined, the most commonly reported events were metabolic disturbances. Of the 3 categories of events, 1,390 (47.3%) were metabolic disturbances, 1,243 (42.2%) were renal impairment and 310 (10.5%) were reports of hypertension. Hypokalaemia with 539 (38.7%) reported events, was the most common metabolic disturbance. Ipilimumab and cetuximab with 508 and 467 events, respectively, were the most common agents with reported adverse events. Events described in FAERS are reported by providers or patients and could have a reporting bias. In addition, not all demographic and co morbidity information is available, limiting the ability to explore nephrotoxic risk factors and certain other clinical characteristics.

Conclusion: Targeted therapies have a number of nephrotoxic adverse effects. Electrolyte disorders, renal impairment and hypertension are the most commonly reported events. Ipilimumab and cetuximab have the most nephrotoxic events reported from the targeted therapies.

Biography:

Dr. Eugene jamot Ndebia has completed his Ph.D. from Walter Sisulu University. He is a lecturer in medical physiology and biostatistics. As a researcher, he is looking at the relation between lifestyle and cancer of the esophagus in the Eastern Cape region of South Africa where the prevalence of this cancer is very high. Also, he has an interest in clinical trials research. He has published more than 18 papers in reputed journals and serving as an editorial board of many of them.

Abstract:

Ledebouria ovatifolia is a wild plant widely used for medicinal purposes including diarrhoea, stomach ache and gastric ulcer in Africa rural settings. This preliminary screening aimed to evaluate the healing effect of L. ovatifolia on experimental induced gastric ulcer in vivo. Indomethacin (50 mg/kg, p. o.), ethanol (2 ml/rat, p. o.) and stress were used to induce gastric ulcer. The anti-ulceration lesion index was calculated, also the macroscopic and histopathologic assessment were made. The results showed that oral administration of L. ovatifolia significantly decreases gastric ulcer as compared to control group. Macroscopic and histopathologic evaluation of ulcerated stomachs of L. ovatifolia treated groups showed a reduced area of gastric lesion, with moderate disruption of the gastric epithelium as well as the mucosa stromal cell. This finding suggested that L. ovatifolia can be used for its anti-ulcerogenic properties, which may support evidence for its traditional utilization.

Biography:

Chun Li has completed her MS on Analytical Chemistry from University of Waterloo, Canada. She has worked in DMPK groups within 3 different Pharmaceutical companies for over 25 years. She first joined Merck Research Laboratories in Canada in the year 1990, and then moved to Amgen in 2001 supporting both Discovery and Development DMPK. In 2008, she joined Genomics Institute of the Novartis Research Foundation (GNF) in San Diego, supporting discovery projects. She has authored or co-authored more than 35 papers in reputed journals and is a member of American Association of Pharmaceutical Scientists (AAPS).

Abstract:

Successful drug discovery relies on selection of drug candidates with good in vitro ADME and in vivo pharmacokinetic properties as well as appropriate preclinical efficacy and safety profiles. However, in vivo animal pharmacokinetic studies are still conducted in a traditional low throughput manner, and therefore, are often the bottlenecks of discovery projects in many pharmaceutical companies. This presentation will focus on the tiered in vivo PK approaches, including snapshot PK, rapid PK and full PK study designs which we have implemented to support our drug discovery efforts. In all 3 approaches, compound is dosed and analyzed discretely, thereby eliminating any drug-drug interaction concerns and analysis complications typically associated with cassette dosing or cassette analysis. The rapid PK approach uses several integrated and automated processes and sample pooling strategy to improve throughput, and has become our main stream in vivo PK approach in the lead optimization stage. These in vivo PK approaches differ in throughputs, capacities, the resources required, and are designed to address the varying needs of drug discovery projects at different stages of project progression. These approaches are well integrated within discovery research, allow tremendous flexibility and are highly efficient in supporting the diverse needs and increasing demand for in vivo profiling. Examples of each of the tiered in vivo PK studies will be illustrated.

Biography:

C.R. Sewani-Rusike completed her PhD studies at Michigan State University (East Lansing, USA) after which she studied Medicine at the University of Zimbabwe. Her primary research interests are in Reproductive biology – investigating the effects of indigenous plant foods and medicinal plants on reproductive function.

Abstract:

Metabolic syndrome is a growing problem worldwide and in South Africa. It encompasses obesity and its associated complications including dyslipidemia, hypertension, insulin resistance which predisposes to the development of type 2 diabetes. Food plants are being investigated as nutreucicals to combat obesity and its complications. Mormodica foetida is commonly used in the Eastern Cape of South Africa as a vegetable and condiment in food preparations. Additionally, it is used medicinally for the treatment of hypertension. In the present study, the effects of a hydroethanolic extract of M. foetida on metabolic syndrome were investigated in a high-energy diet-fed (HED) rat model at a dose 150 mg/kg body weight. After 12 weeks on HED, rats were treated daily with extract for five weeks. Untreated rats showed fat accumulation, glucose intolerance, increased blood pressure, increaed LDL, reduced sperm motility with no change in sperm count. Treatment with M. foetida improved all parameters with an increase in sperm count. However, no significant change in serum HDL cholesterol was observed in both untreated and treated rats. These results show potential for M. foetida in the treatment of obesity and associated metabolic disorders.

Biography:

Joe Martinez serves as the CEO of Center Point Clinical Services. He brings over 30 years of successful leadership experience in the pharmaceutical, biotech and Medicaid industries. He instituted novel industry programs utilizing RWE (real world evidence) and health outcomes information to communicate product value information to health care decision-makers. His research abstracts and poster presentations have been accepted by national and international associations including ADA, ASCP, AMCP, AGS, AADE and AACE.

Abstract:

Poor patient retention and medication compliance represent an ongoing challenge in clinical trials. Patients have many instructions to follow and can become frustrated easily. In fact, according to research by the Tufts Center for the Study of Drug Development, 49% of all patients randomized into a clinical trial quit before study completion. Clinical trials provide important and critical medical and clinical data that are required for FDA review and approval of a drug, device or procedure application. Addressing the patient’s need for medication information can increase protocol compliance; while increased patient retention and can have a beneficial impact on achieving primary endpoints and health outcomes. Statistical analysis of multiple clinical trials involving a chronic disease medication (diabetes) with clinical pharmacist medication counseling resulted in total of 21,582 CTRP (Pharmacist) calls were made to 3,124 clinical trial patients, 92.8% (2,900) of patients had at least one intervention, 45.7% (9,845) of clinical patient calls had at least one intervention and most frequent interventions were for concurrent medications (31.7%), miscellaneous concerns (24.9%), side effects (19.0%) and IVRS (19.0%). Clinical pharmacist medication counseling support was observed as a motivating factor for the patient to comply with study protocol directions and provided enhance patient retention. Increasing patient retention can save an average of $36,500 per patient and potentially shorten the study duration. Patient compliance increased by more than 25% percent and patient retention rates improved by 60 percent in these clinical trials, with results ranging up to 93 percent retention when compared to anticipated outcomes.

Biography:

Dr.Usta is a board certified pharmacotherapy and Nutrition specialist with extensive hospital and patient care experience as Pharmacy Director at AUBMC. She earned her Doctor of Pharmacy degree from Saint Joseph University and completed her Master at Belfast University, a Diploma of economic science from ESA and Leadership certificate from ASHP Leadership Institute. Leadership Institute at ASHP November 2010She is active member of various professional societies such as the American Society of Health-System Pharmacists, American Clinical College of pharmacists. For more than 25 years, she led the implementation of unit-dose distribution system, IV admixture units and clinical pharmacy services at AUBMC. Her primary research interest focuses on pharmacy practice, leadership, patient safety, antimicrobial use and pharmacoeconomic and pharmacovigilance. She is a frequent speaker at national and regional pharmacy events.

Abstract:

Purpose: The purpose of this study is to describe the experience of developing and implementing a pharmacy SharePoint as a single resource point to ensure effective and user-friendly communication and documentation of clinical interventions in a tertiary care center.

Background: The American University of Beirut Medical Center is a 350-bed capacity tertiary care teaching hospital in Lebanon. The pharmacy operates 24/7 with a Comprehensive Unit-based model where the pharmacists are assigned to adults, pediatrics, oncology, operation and night shift teams. This new structure led to increased challenges in communicating information within the department; communications was mainly through emails, multiple steps to reach references, and manual documentation to capture and track clinical activities (e.g. clinical rounds, chart documentation, time spent at the unit, follow up on restricted antimicrobial use and multidisciplinary meetings).

Methods: The configuration of the pharmacy home page and the content was agreed upon with the IT department and the pharmacists’ team leaders. The home page includes links to frequently utilized external (e.g. Micromedex, Medscape, out-patients’ formulary for third party-payers) and internal information (e.g. policies and procedures, order sets and protocols). Within the clinical services area are charts, standardized drip protocols, guidelines, stability sheets, compounding instructions and formulary applications include scheduling, calendar to reserve annual vacation, and parenteral nutrition software. Likewise, announcement section with temporary links was added to the home page to draw attention to important but transient information, such as an announcement for drugs in shortage, availability of newly approved drugs. Hierarchy of restriction was set with different access levels as owners, members and visitors and an alert setting was customized to provide e-mail alerts when information is updated or added. Quick launch buttons to document clinical activities and place follow up note on the inpatients’ dashboard using a scroll down option was created with the ability to generate reports to compile and analyze the data which is currently under development to be accessible through ipads and smart phones. The major future challenge is to persuade the pharmacist to make use of it. Future development will include training material and annual competency programs for pharmacists and technicians.

Results: After site initiation and training were completed, staff pharmacists found that SharePoint an improved method of document storage and communication. Survey to get staff feed-back is planned after full implementation.

Conclusion: Pharmacy SharePoint offers many applications to improve communication and achieve real-time capture of meaningful benchmarking data, but staff adoption and utilization of this resource will be the keys to success.

Biography:

Dr.Krishnan, did his post graduation in pharmacology from prestigious Stanley Medical College, India. He is research cordiantor of Saveetha Medical College. I have been engaged in medical teaching, functioning as consultant for CROs and Ethics committees.I have fetched prizes for research presentations in various proceedings and has five publication in Thomson Reuters, PUBMED and four papers in SCOPUS indexed journals.

Abstract:

Objectives: To evaluate the current knowledge about code of ethics involved in biomedical research To assess the researcher’s knowledge on informed consent process doing biomedical research.

Methodology: This cross-sectional study was conducted using validated questionnaire between January and April 2016. Questionnaire consists of two sections; in first section knowledge of basic ethical principles of human research was elucidated. In the second section, specific questions regarding informed consent process was asked to our study population of our sampling unit using random sampling method.

Results: Out of 250 biomedical postgraduates, 165(66%) researchers were found to have adequate knowledge about basic ethical principles.113(45.2%) researchers found to have knowledge on informed consent process and 137(54.8%) researchers still need to enlightened on the same. Subgroup analysis showed this significant difference (p < 0.05) seen between first and final year postgraduates; the later possessed more knowledge of biomedical principles.103 (41.2%) researchers have attended special workshops related pertaining specifically for bioethics.

Conclusion: Our study reflected satisfactory trend among Indian biomedical postgraduates about bioethics; however workshop and training should be emphasized for fresher’s at an earlier stage of their curriculum which will facilitate them to conduct their thesis with ethical concern from the inception. Bioethics lessons should be conducted for all biomedical researchers periodically to update the amendments

Biography:

Praveen Oberai has completed her BHMS from Delhi Board, MD from Agra University and Post-graduate diploma in Bio-ethics and IGNOU in collaboration with ICMR. She is working in Central Council for Research in Homoeopathy Headquarters, a premier institute of research through Homoeopathy, for more than 25 years and is heading the Department of Clinical Research. She had been actively involved in preparation of evidence based protocols prepared in consultation with the scientists of allied sciences, homoeopathic experts and bio-statisticians. In addition to this, she is also coordinating the Public Health Program of Ministry of Health and Family Welfare: Integration of Homoeopathy/Yoga in National Program for Prevention and Control of Cancer, Cardiovascular diseases, Diabetes and Stroke. She has to her acclaim more than 36 papers published in national and international journals of repute. She has also presented papers in various national and international seminars in India and abroad on subjects like research methodology, activities of CCRH, role of Homoeopathy in various disease conditions and outcome of various clinical research studies conducted by the council.

Abstract:

Objectives: To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy.

Methods: A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and enrolled after fulfilling inclusion/exclusion criteria. Patients were evaluated by the Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months.

Results: Out of 336 patients enrolled in the study, 247 patients were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score (p=0.0001) was found at 12 months from baseline. Lycopodium clavatum (n=132), Phosphorus (n=27) and Sulphur (n=26) were the medicines most frequently prescribed. Adverse event of hypoglycemia was observed in one patient only.

Conclusion: This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the Quality of Life (QOL) assessment.

Biography:

Sheraz Ali has completed his MPH degree on scholarship from University of Eastern Finland and PharmD from Baqai Medical University. He is currently working as a Researcher at Pharmaceutical Care Services, King Saud Medical City, Ministry of Health, Saudi Arabia, and involved in several clinical research projects. He also worked as a Clinical Research Associate in CRO and pharmaceutical industry and was a part of local and international clinical trials. He is a registered researcher in Saudi Arabia and also a member of International Society for Disease Surveillance (ISDS).

Abstract:

The clinical trial is an important type of research design in the spectrum of translational research. The extent to which clinical trials are conducted is a reflection of the level of advancement that exists within a healthcare system – a single provider, an organization (e.g. a hospital), or a national healthcare system. This study aims at describing the clinical trial activity within the Kingdom of Saudi Arabia since 2000 through reviewing those trials that have been registered with ClinicalTrials.gov in that time period. Since February 2000, 405 trials have been registered with ClinicalTrials.gov. These trials fall into one of 22 different ICD-10 codes, and with the top four being neoplasms (92), diseases of the circulatory system (57), endocrine, nutritional and metabolic diseases (46), and diseases of the respiratory system (25). Among the 405 trials, about half (200) were classified as trials with both safety and efficacy endpoints. Fifty-two percent were phase IV trials and 28% were phase III. About 64% were randomized, and with about equal numbers of those trials coming from industry (86) and university sponsors (85), and smaller numbers coming from hospitals (51) and other sponsors. Among the 185 university- or hospital-sponsored trials, the most common was a phase IV neoplasm trial (11) and next being a phase IV trial of diseases of the circulatory system (9). A total of 24 phase III university- or hospital-sponsored trials have been registered during the 15-year time period. With a population approaching 30 million and very large annual healthcare expenses, it would appear that the level of clinical trial activity within the Kingdom during the past 15 years has been rather paltry. The emphasis has been on post-marketing phase IV trials. The academic setting (i.e. universities and hospitals) has seen a new trial registered every 11 months on average. This study is solely based upon the information as registered in ClinicalTrials.gov. There is the possibility that other trials not registered could exist. However, it is thought that the resource would include those trials of a higher quality and more rigorous.

Biography:

Ramandeep Kaur Brar has completed her B.Pharm and currently pursuing MSc in Clinical Research at University Center of Excellence in Research, Baba Farid University of Health Sciences, India. She has published one chapter in book and one Paper “Scope and Bottlenecks in Clinical Trials of Herbal Drugs” in the Journal of Pharmaceutical Research.

Abstract:

Ethics committee is supposed to play a great role in safe human research. It is mandatory that all research projects related to health sciences with involvement of patients/subjects should be approved by IEC before commencement. The data available reflects the low percentage of awareness amongst the routine project investigator. Being inclined towards medical education only, awareness amongst faculty members of medical colleges towards ethics committee is also expected not up to the mark. Indian Council of Medical Research has launched and funded development of Multidisciplinary Research Unit (MRU), a scheme for igniting research component in various medical colleges of India. Keeping in view the above situation, a study was designed to check the awareness about the composition, review procedure and functioning of IEC amongst the research scholars/teachers in government medical colleges of Punjab. The information was sought in form of a questionnaire from a total of 50 participants. From the study it was observed that only 10% had undergone ICH-GCP training. A few participants (6%) served as member of IEC and demonstrated a very poor knowledge index about IEC. Only 68.5% participants were aware about its composition and majority of respondents (86%) felt that there was a need of training before becoming a member of IEC. From the data it is very clear that there is strong need of training to faculty of medical colleges towards institutional ethical committee. There is a need to inculcate the IEC-ICH guideline in curriculum of post-graduates medical students and medical teachers.

Biography:

Supreet Kaur Gill has completed her Bachelor of Dental Surgery from Adesh Institute of Dental Sciences and Research, Baba Farid University of Health Sciences, India. Currently she is pursuing her Post-graduation (MSc) in Clinical Research from University Centre of Excellence in Research, Baba Farid University of Health Sciences, India. She has published one paper in Asian Journal of Pharmaceutics and Clinical Research.

Abstract:

Clinical research is making toiling efforts for promotion and wellbeing of the health status of the people. There is a rapid increase in number and severity of diseases like cancer, hepatitis, HIV etc., resulting in high morbidity and mortality. Clinical research involves drug discovery and development whereas clinical trials are performed to establish safety and efficacy of drugs. Drug discovery is a long process starting with the target identification, validation and lead optimization. This is followed by the preclinical trials, intensive clinical trials and eventually post marketing vigilance for drug safety. Softwares and the bioinformatics tools play a great role not only in the drug discovery but also in drug development. It involves the use of informatics in the development of new knowledge pertaining to health and disease, data management during clinical trials and to use clinical data for secondary research. In addition, new technology likes molecular docking, molecular dynamics simulation, proteomics and quantitative structure activity relationship in clinical research results in faster and easier drug discovery process. During the preclinical trials, the software is used for randomization to remove bias and to plan study design. In clinical trials software like electronic data capture, Remote data capture and electronic case report form (eCRF) is used to store the data. The eClinical, Oracle clinical are softwares used for clinical data management and for statistical analysis of the data. After the drug is marketed the safety of a drug could be monitored by drug safety software like Oracle Argus or ARISg. Therefore, softwares are used from the very early stages of drug designing to drug development, clinical trials and during pharmacovigilance. This review describes different aspects related to application of computers and bioinformatics in drug designing, discovery and development, formulation designing and clinical research.

Biography:

Yanning has received a PHD degree in statistics from Cornell University. She is a principle statistician at Johnson and Johnson. She has published more than 20 papers in statistics, clinical trials and biology

Abstract:

The basic problem that causes the frequent failure of a standard randomized parallel placebo-controlled clinical trial with a high placebo response rate is the underestimation of the treatment effect by the observed relative treatment difference. A two-period sequential parallel enrichment design has been proposed where the first period is a standard parallel design and at the end of the first period, the placebo non-responders are identified and re-randomized in the second period. Based on such a design, available methods have primarily focused on testing either the first period treatment null hypothesis or the global null hypothesis defined as the joint period 1 and period 2 treatment effect null hypothesis by a test statistic which is either derived from a combined statistic or defined directly as a weighted z-score where the weights are functions of some population and design parameters satisfying certain power optimality criterion. However, in some cases, it is not clear what their combined statistics are estimating and in others, the combined statistics are estimating the apparent treatment effect; but generally, there is no discussion of the need to provide a proper assessment of the treatment effect for the intended study population. It should be clear that an appropriate assessment of the treatment effect for the intended study population is critical for the benefit/risk analysis as well as the proper dosage recommendation. Any benefit/risk analysis and dosage recommendation that are based on an apparent treatment effect from a standard parallel design such as the first period of a sequential parallel enrichment design tend to underestimate the benefit/risk ratio which in turn may lead to overdosing recommendation. It is the purpose of this paper to introduce the concept of an adjusted treatment effect which is derived by adjusting the apparent treatment effect from the first period of a sequential parallel enrichment design with information from the second period subject to a consistency condition. The adjustment properly compensates for the high placebo response rate. It is proposed that this adjusted treatment effect should be used to assess the treatment effect for the intended study population and should be the basis for the benefit/risk analysis and the dosage recommendation.

Biography:

David R Jones, BSc, MSc, EurBiol, CBiol, MRSB, MTOPRA, European Registered Toxicologist After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, whom I joined in 1996. My current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological. A further aspect of my job is to offer regulatory advice to companies on behalf of the MHRA or the EU’s Committee for Human Medicinal Products (CHMP). I am one of the UK’s accredited non-clinical experts to support the CHMP and am the UK representative on the EU’s Safety Working Party (SWP). I represented the EU in the ICH revision of the M3 Guideline and on the ICH S10 Guideline. I am now EU Rapporteur on the new ICH S11 (Juvenile Animal Studies) guideline and the Q&A document for ICH S3 (Toxicokinetics). I am also a guest lecturer at the University of Surrey, the University of Wales, and the University of Leicester and a frequent presenter at conferences around the world.

Abstract:

The EU is introducing legislation aimed at harmonising the way in which clinical trials conducted in the Europe are authorised and at improving the reliability of data generated in those trials. The Regulation replaces the EU Clinical Trials Directive (EUCTD), which was approved in 2001 and implemented in May 2004. The regulation will introduce and include a number of key provisions. There is an authorisation procedure for clinical trials based on a single submission dossier via a single EU portal, an assessment procedure leading to a single decision on all aspects per member state, rules on the protection of subjects and informed consent, and transparency requirements. Other aspects include more detailed safety provisions, new indemnity provisions and a category for low interventional trials. The new regulation also intends to make it easier for pharma companies to conduct multinational clinical trials. The talk will cover review the new Regulation, highlighting what will change from the Directive and advise companies how to gear up for its implementation.

Biography:

Jane A Otado has completed her PhD in Medical Sociology/Social Demography from Howard University and Postdoctoral studies from Centers for Disease Control and Prevention (CDC). She is currently the Associate Director of Regulatory, Ethics Knowledge and Support (REKS), a component of the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS), a CTSA research grant funded by National Institute of Health (NIH). She has held various health services research workshops, research ethics, GCP and human research protection training relative to compliance. Her area of research interests include access to and availability of health care particularly as it relates to minority health, adolescent health, prenatal care utilization, elderly African American and access to health care, minority participation in clinical trials. Her recent research involves post-consent understanding among at risk minority population and recruitment strategies for recruitment and retention of African American population into clinical trials and research participant satisfaction surveys. She serves on the Howard University biomedical IRB, on the GHUCCTS protocol review committee and a Member of the GHUCCTS Steering Committee.

Abstract:

Purpose: To identify successful recruitment strategies, challenges and best practices for researchers to engage African American communities in clinical studies taken into consideration target participants’ culture and context. Methods: We reviewed 50 studies conducted from 2001-2012 at an inner-city research center to determine the type, duration, anticipated enrollments and actual enrollments. Survey was sent to study coordinators to obtain data on recruitment and retention strategies, challenges and dropout rates. We also interviewed 25 study coordinators on challenges and strategies. Results: Of the 50 studies, 24 had completed recruitment at the time of this report. The completed studies achieved a median recruitment rate of 88% [range: 50-110]. Successful recruitment and retention strategies included field-based strategy and snowballing. Major barriers were distrust, compensation, education disadvantage, lack of interest and inability to have study partner. Strategies to reduce barriers included providing informational sessions, disseminating newsletters about study outcomes. Best practices include being culturally sensitive including demonstrating a caring attitude and being responsive to participants needs. Conclusions: Cultural competence is critical in order to design and implement successful recruitment strategies in this population. Research teams should comprise of multi-ethnic staff, involve the community, demonstrate trust and deliver concise education of the research endeavor.

Biography:

Abstract:

Vitamin D, commonly known as sunshine vitamin, is both indispensable and vital for human beings. The prevalence of vitamin D deficiency (VDD) is on the rise globally including the sunny regions such as in the UAE. The aim of this study was to examine the relation between the degree of chronic vitamin D deficiency as a risk factor of the incidence of type 2 diabetes mellitus among adult populations. This is a single-centre observational retrospective cohort study conducted in a tertiary hospital in the UAE. It was mainly based on reviewing the electronic data-base and medical records of all chronic patients that match the inclusion criteria. The inclusion criteria of this study included all adult patients aged between 18 and 55 years old, tested for vitamin D level, visited the practice at least three times in the past year. The exclusion criteria included renal failure patients, patients who had malabsorption disorders and those with T2DM risk factors. A sample size of 35,000 adult patients who were screened in a period of 12 months for vitamin D level was selected using the lab database. Patients were checked against the inclusion criteria and of them, only 391 patients met the inclusion criteria. Other diabetes risk factors such as obesity, family history, pre-diabetes, presence of co-existing hypertension and dyslipidemia were also reviewed and excluded. The results of this study showed that a total of 56 patients [14% (95% CI 10.56- 17.44)] had normal results compared to 335 patients [86% (95% CI 82.56-89.44)] who had a chronic vitamin D deficiency. In addition, the results showed that 17% (95% CI 13.28- 20.72) of the 391 patients had mild vitamin D deficiency (VDD), 31% (95% CI 26.42- 35.58) moderate VDD and 38% (95% CI 33.2- 42.8) severe VDD. A total of 32% of patients with severe vitamin D deficiency developed diabetes compared to only 16% from patients with normal vitamin D deficiency and statistically showed significant difference from all other VDD groups as to developing T2DM. This indicates that the more the severity of vitamin D deficiency, the more the susceptibility to develop T2DM. Of a note, in the prevalence of severe chronic VDD, female patients showed significantly higher percentage (61%) of VDD compared to their male counterparts (39%). According to the results of this study, there is a clear relation between severe vitamin D deficiency and incidence of type 2 diabetes mellitus, whereas, mild and moderate VDD showed no difference from normal.

Biography:

Abstract:

Context: Warfarin and similar vitamin-K antagonists have been the standard therapy for patients with a metallic valve or bioprosthesis with atrial fibrillation. Even with the appropriate use of therapy, there is a high incidence of thromboembolic events: 1-4% per year. Furthermore, bleeding risk is significant ranging from 2% to 9% per year. Objective: To examine the effect of dabigatran etexilate versus dose-adjusted warfarin for the prevention of intra-cardiac thrombus in persistent or permanent atrial fibrillation (AF) after at least 3 months after aortic and/or mitral bioprosthesis replacement. Design, Setting and Participants: DAWA is a phase-2, prospective, open-label, randomized, pilot trial designed to compare 110 mg twice-daily oral dabigatran etexilate with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in persistent or permanent atrial fibrillation after bioprosthesis replacement (through research of intra-cardiac thrombus). From August 2013 to April 2015, 100 patients at least 3 months after aortic and/or mitral bioprosthesis replacement and AF postoperatively, who match eligibility criteria will be selected from Ana Nery Hospital in Salvador-Bahia with follow-up of three months.