4^th International Conference on Clinical Trials September 11-13, 2017 San Antonio, Texas, USA
(10 Plenary Forums - 1 Event)

Biography:

Oleg V. Tcheremissine, MD, is a Professor of Psychiatry and Research Director for the Carolinas HealthCare System Department of Psychiatry and Behavioral Sciences. He is a board-certified Psychiatrist and Clinical Investigator with more than 25 years of medical and more than 20 years of research experience in human behavioral and clinical psychopharmacology. Dr. Tcheremissine has successfully combined his research interest, teaching, clinical, and administrative responsibilities while focusing on eliminating external and internal barriers to development of novel and innovative treatments with the overall goal of reducing health disparities, improving access to care and increasing the generalizability of clinical trials results.

Abstract:

Alzheimer’s Disease (AD) is a progressive neurogenerative disorder with a wide range of symptoms affecting memory, concentration, volition, and almost all aspects of human behavior. The prevalence of patients with AD is increasing due to an aging population. There is real possibility that without medical breakthroughs, the current 5.3 million Americans diagnosed will triple to 13.8 million by 2050. Delivery of compressive care is facing a crisis stemming from a combination of factors -- a growing demand for such care, insufficient number of those specialized in this therapeutic area, rising costs of care, the complexity of the diseases and lack of effective treatment. Despite massive research efforts in recent decades, new treatments for AD remain elusive. Since 1998, there have been more than 100 attempts to develop new pharmacological agents, and all have failed. Patient population included in these clinical trials typically suffered from mild-moderate AD. Most of them were initially diagnosed and treated by their primary care providers. Early identification of a cohort of those who will benefit from clinical trial participation by is a strategic priority. CHS has made an investment in developing a comprehensive dementia care though a collaboration of different service lines including Neurosciences, Behavioral Health, Primary Care and Geriatrics. This bidirectional reciprocity allows to align the process of drug development with information derived at the “point of care”, and provides an opportunity to further breech the “efficacy-effectiveness” gap, commonly defined as the differences between two populations of patients, those enrolled in clinical trials and those who will be treated in real clinical settings.

Biography:

David is a well-known leader and change agent in the clinical research industry.  He lives outside Nashville, TN where he involves himself in work, family life and other charitable and entrepreneurial opportunities.

Abstract:

Over the past several years there has been a resurgence of efforts to gain access to investigational products outside of clinical trials.  Previously failed attempts a decade or so ago at the federal judicial level has turned advocates’ strategy to pushing states to pass variants of so-called “Right To Try” laws in an effort to circumvent the FDA’s Expanded Access policies.  Over the past several years, a majority of states have now done so.  While ethicists debate the battle of the good vs. the good of this kind of access, and lawyers debate the state’s rights to have these kind of laws, the FDA and the advocates debate their respective track records.  Nevertheless, the issue has gotten the attention of the federal legislators through passed acts (evidenced by certain section in the 21st Century Cures Act) as well as putting forth proposed legislation for a national Right To Try Act.  With the current congress and the executive branch leaning towards the advocates’ position, it is likely that we will see continued movement.  This session provides a comparison of the varying state “Right To Try” laws and summaries of the most recently passed and proposed federal laws related to this topic.

Biography:

Valerie G Sams completed her fellowship in trauma and surgical critical care at San Antonio Military Medical Center (SAMMC), San Antonio, Texas in 2015. She is a trauma and general surgeon at SAMMC and an extracorporeal membrane oxygenation (ECMO) provider. She has published more than 15 papers in reputed journals and is active in multiple funded research projects.

Abstract:

Hyphema is blood that is grossly visible in the anterior chamber of the eye and can cause permanent vision loss. It is a rare complication that usually occurs after ocular trauma. Spontaneous or nontraumatic hyphema may result from underlying bleeding disorders, anticoagulation or antiplatelet medications, vascular malformations, ocular abnormalities, closed-angle glaucoma, sickle cell anemia, acute leukemia, rheumatologic disorders, or lymphoma. Rarely, spontaneous hyphema may present after non-ophthalmic surgery due to intra-operative heparin administration, coagulopathy, severe hypertension, or during emergence from anesthesia. Here we present a case of a man with acute respiratory distress syndrome (ARDS) as a result of Influenza B infection who underwent lung protective mechanical ventilation strategy, sedation, paralysis, and prone positioning to assist with oxygenation. This is the first reported case of non-traumatic hyphema in a patient undergoing prone positioning as part of the management of ARDS. We postulate that the patient’s thrombocytopenic state coupled with the increased venous drainage pressure in the eyes from the face-down prone positioning likely led to his development of bilateral spontaneous hyphemas. Positioning his head to the side normalized venous drainage pressure and allowed rapid reabsorption of the anterior chamber blood. Hyphema should be considered a potential complication of prone positioning in patients with ARDS, especially in patients with a concomitant bleeding diathesis. In our patient, early recognition and medical intervention led to complete resolution. Ophthalmology evaluation and management is important for successful recovery. 

Biography:

Richard Entsuah is a Fellow of the American Statistical Association. He completed his PhD from University of Michigan. He was an Assistant Professor of Biometry at University of Illinois in Chicago. He joined Wyeth Research from 1988 to 2007 and left as an Assistant Vice President of Global Biostatistics and Programming. He joined Merck Research Labs as Executive Director of Late Development Statistics and is the Research Group 4 Head for Neuroscience and Respiratory of and Immunology. 

Abstract:

In the area of pharmaceutical drug safety, one of the primary goals in analysis of adverse events (AEs) is to detect any signal of a difference between the treatment and control groups. Traditionally, crude incidence rate, chi-square test or Fisher's exact test, and Miettinen and Nurminen are the useful methods in analysis of single AE data depending on what level of importance it belongs to, such as Tier 1, Tier 2, or Tier 3, which were defined by Merck. Actually, the occurrence of AEs is very complicated. Simple measurement of AE data without enough information including duration effect, severity effect, or recurrent event, the estimation and inference could be biased. Moreover, multiple AEs within the same system organ class (SOC) are usually correlated with each other. So analysis of single AE over simplifies comparison among treatment arms in drug safety. In this presentation, we would like to propose a new class of distribution-free approaches to address the effects of duration, severity, and recurrence of AE data by using a new measurement within certain specified class. The good asymptotic properties and robustness for the proposed models have been shown in this study. The numerical simulation studies and a case study example are provided for illustrations. 

Biography:

Joann Pfeiffer completed her Doctorate of Science, in Regulatory Science from the University of Southern California. She is currently the Director and an Associate Professor, in the Clinical Research Managment Graduate Program at Arizona State University. She has published several books related to managing contracts and budgets in clinical trials, conducting clinical trials at study sites, as well as articles in peer reviewed journals. Her expereince includes over 20 years in the management of clinical trial operations in both academic and non-academic settings. 

Abstract:

Clincal trial agreements are legal and binding, forming the foundation for a successful partnership between study sites and sponsors. Not understanding the legal language and the terms of the contract can lead to financial and legal ramifications for the site, the investigator, and study staff. Terms and language of the contract will be reviewed focusing on risk areas and protecting the site. Through interactive activities participants will review and revise contract language to meet the needs of the site. Proper management of contracts includes knowing what you are agreeing to, prioritizing site needs, and utilizing site metrics and successful strategies to negotiate a fair and balanded contract. Strategies include redlining contracts with preferred language, naming and version control, reviewing related study documents for consistency, contract definitions, addressing the responsibilities of the contract parties, and asking questions for clarification. The session will finish with contract tips.

Biography:

Manuel Castro has been with Carolinas Healthcare System for 9 years and serves as the Vice-Chief Department of Psychiatry, Medical Director of Behavioral Health Integration, and Assistant Medical Director of outpatient medication services. In 2016 he was honored to become a Fellow for the American Psychiatric Association. He leads the Behavioral Health Integration team in servicing ambulatory care practices across the healthcare system through a virtual platform. He is Board certified in adult psychiatry. He is the recipient of the Brian R Nagy MD teaching award at CMC-Randolph and is an adjunct Associate Professor of psychiatry with UNC-Chapel Hill. 

Abstract:

In March 2014, the Behavioral Health Service Line within Carolinas HealthCare System launched a transformative integrative care model utilizing virtual and population health management tools to reach out to patients with behavior health symptoms through ambulatory care settings (primary care, internal medicine, and pediatric clinics). The goal of the collaborative care initiative is to improve access to behavioral health services by providing evidence-based, innovative, timely, seamless and coordinated care that meets patients’ individual needs; by increasing the detection of mental illness through appropriate screening; increasing access to behavioral health coaching; providing treatment and medication oversight, improving clinical outcomes; strengthening relationship with ambulatory care providers; decreasing avoidable healthcare utilization and achieving higher rates of treatment adherence; while decreasing the overall cost of care overtime. In 2016, the program achieved a dramatic 43% decrease in depression (PHQ-9) and 38% decrease in anxiety (GAD-7) symptoms scores. 49% of the patients achieved 50% or more reduction in their raw depression scores as a result of telephonic health coaching. Over 80% of the program participants with suicidal ideations at baseline denied suicidal ideations at the completion of the program. Through implementation of the virtual model, ambulatory care clinics have immediate access to behavioral health services via video technology and other resources. Thus, assessment and treatment planning can begin immediately, and follow-up care can be coordinated between the behavioral health team and medical providers all in one visit. 

Biography:

Sarah brings to IntegReview IRB over 20 years of experience in Operations and Business Development in clinical research and is currently Director of Client Services. Prior to joining IntegReview, Sarah was the Vice President for a research site organization. She was responsible for the clinical operations of their multiple Phase I – IV clinical research sites and developing the CRO business to provide project management and monitoring services. Prior to management, Sarah has held various positions including Clinical Research Coordinator, CRA, Project Manager and Consultant for CROs and Sponsors and has a background in hospital research, pharma, medical devices, nutraceuticals and biotech. 

Abstract:

Have you considered how the revisions to the common rule may affect your next research project? There are a number of questions circulating on how these changes will be implemented effectively and efficiently within the academic communities and other institutions, but also the impact that they may have on all industry sponsored research. Important elements in the final rule issued include: The requirement for consent forms to provide potential research subjects with a better understanding; requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies; for studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement; the establishment of new exempt categories of research based on the level of risk they pose to participants; removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects and requirement that consent forms for certain federally funded clinical trials be posted on a public website. This session will look at the changes and discuss the impact on human subject protection, informed consent for research sites and IRBs.

Biography:

As the Vice President of Compliance, Melanie is responsible for the daily leadership, management and full responsibility for the Company’s compliance program. Melanie has worked in the IRB industry since 1999 and has been with IntegReview since 2001. Prior to leading the Regulatory Compliance Department, her main focus for 9 years was spent providing training to IRB staff and IRB members to ensure compliance with Federal Regulations, ICH Guidelines, IntegReview IRB Standard Operating Procedures and standards of the AAHRPP.

Abstract:

Have you considered how the revisions to the common rule may affect your next research project? There are a number of questions circulating on how these changes will be implemented effectively and efficiently within the academic communities and other institutions, but also the impact that they may have on all industry sponsored research. Important elements in the final rule issued include: The requirement for consent forms to provide potential research subjects with a better understanding; requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies; for studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement; the establishment of new exempt categories of research based on the level of risk they pose to participants; removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects and requirement that consent forms for certain federally funded clinical trials be posted on a public website. This session will look at the changes and discuss the impact on human subject protection, informed consent for research sites and IRBs.

Biography:

Chris Chan is Executive Director of R&D Finance at FibroGen, Inc, and has over 25 years industry experience, including 20 managing clinical trial and R&D finances for biopharmaceutical companies of various sizes. He holds an MBA from UC Berkeley’s Haas School of Business and is a Certified Management Accountant (CMA) and Certified Financial Manager (CFM). He has served as speaker and chair at numerous industry conferences, and has authored multiple published articles on clinical trials budgeting, accruals, and outsourcing.

Abstract:

Like many marriages, the sponsor/CRO relationship is often fraught with strife and adversity. These conflicts typically center around issues including lack of good communications, misaligned expectations, and other common challenges. This presentation explores common pet peeves frequently observed and experienced by both sides. Real-life case studies/anecdotes from various companies will be used and respective conflicts and resolutions will be examined in detail. Common lessons learned that may be applied to current and future sponsor/CRO relationships will be discussed.

Biography:

Brian is principal and vice president at Tanner-Ibbotson, Inc, an insurance brokerage located in the Northeast part of the United States. With a focus on providing insurance solutions for pharmaceutical and medical device companies, he brings over a decade of experience in the industry. His practice helps companies procure insurance both domestically and internationally. Brian hold bachelors’ degrees in business administration and polical science from Pepperdine University in Southern California. 

Abstract:

A key component of international clinical trials that is often overlooked is insurance considerations for the country where the study will be performed. Failure to comply with jurisdictional or IRB insurance requirements can delay approval for the start of a trial. In drug development, any delay could cost the sponsor millions of dollars. Having the proper insurance program structure is also critical to avoid any gaps in protection.  Working with a qualified insurance broker that has key relationship with global insurance companies is critical.  A proactive approach and understanding of the parameters of insurance procurement for global clinical trial will produce a well managed clinical trials insurance process as it relates to efficiency, affordability, protection and ease of administration.  

Biography:

With over 30 years experience in scientific and business computing Michael is a recognized leader in visualization technology worldwide. He created the oil industry’s first commercial 3D visualization center. He received the Carnegie Mellon and American Management Institute Award for Innovation in Information Technology. His work was honored with a permanent position in the Archives of the Smithsonian Institution. He founded Magic Earth, LLC. in 2000, and as Chairman and CEO, achieved profitability in three months and was acquired by Halliburton that same year for $100 million. Michael holds a B.Sc. in Earth and Space Sciences and M.Sc. in Marine Environmental Science from the State University of New York at StonyBrook.

Abstract:

TBD

Biography:

Lauren Ballina has a degree in Psychology and Masters in Biomedical Science. She is a SOCRA-certified CRC. She coordinated clinical trials at the University of North Carolina at Chapel Hill and The Mayo Clinic Arizona. She is currently the National Program Director at Clinical Research Fastrack. She is a natural educator and passionate about making the field of clinical research a respectable profession and not just a job

Abstract:

The varying level of knowledge, competency, and professionalism of clinical research coordinators at the site level is problematic in clinical research. The role of clinical research coordinator (CRC) is a technical position requiring working knowledge of ICH GCP and the Code of Federal Regulations. CRCs are required to collect and document data appropriately and accurately. Their work can have direct impact on the efficiency and quality of a trial. Of 60 current clinical research professionals surveyed, 4 (7%) reported purposefully seeking a position in clinical research. The remaining 56 reported that they “fell into clinical research” and stayed because the field is so rewarding. All reported on the job training in their entry-level position as inconsistent and incomplete. Many felt overwhelmed in their first position and that experience and mistakes have been their best teachers.

Clinical Research Fastrack (CRF) has sought to standardize entry-level training for CRCs. By delivering a robust curriculum focused on ICH GCP, Code of Federal Regulations, protocol, good documentation practices, adverse events, protocol deviations, clinical trial operations, participant recruitment and retention, responsibilities of study team members including PI, informed consent, and research skills all coupled with a hands-on internship at a clinical trial site, CRF is re-inventing the entry-level CRC. Through training standardization, and utilizing an innovative educational approach of “massed practice” CRF is helping transform the role of coordinator to a profession and not just a job. As more well-trained individuals obtain positions in the field, the industry as a whole will benefit.

Biography:

Scott Gelfand received his Ph.D. in Philosophy from the University of Maryland and his J.D. from Georgetown University Law Center. He is a tenured professor and Head of the Department of Philosophy at Oklahoma State University. His research is focused primarily on issues in biomedical ethics and research ethics. In 2010 he received an NSF grant to develop a novel research ethics course for scientists and engineers.

Abstract:

In 1972, Charles Fried, in Medical Experimentation: Personal Integrity and Social Policy asserted that physician-researchers have an ethical obligation to be in a state of equipoise during all stages of randomized clinical trials. Fried’s equipoise requirement dictates that a physician engaged in research must not believe that one experimental arm of a randomized clinical trial is better or more efficacious than the other arms (must be in a state of equipoise). Although the equipoise requirement has been modified over the course of the last 45 years, the equipoise requirement is currently the fundamental or guiding principle concerning the ethics of enrolling patients in randomized clinical trials. In this talk I will discuss the ethical foundation for the equipoise requirement, what is the current equipoise requirement and ethical/practical problems associated with the equipoise requirement.

Biography:

Dr. Xichun Sun is a practicing surgical pathologist and cytopathologist.  He graduated from medical school in China.  He completed his Ph.D, postdoctoral and residency training and fellowships in the USA.  His current research interest centers about cancer diagnosis, carcinogenesis and cancer metastasis.  He is the author of one monograph and has proposed a new theory on cancer metastasis.

Abstract:

In parallel to the appearance of primordial germ cells during early embryogenesis, the cancer reproductive saga starts with the separation of metastasis initiating cells (MICs) from cancer initiating cells when the primary cancer is still in its infancy.  Prime MICs embark on a journey to the host bone marrow where they undergo further development and regulation.  Migrating MICs are guided by the same CXCR4/CYCL12 axis as used in the migration of primordial germ cells to the genital ridge.  Like the ovary, the host bone marrow features immune privileges, coolness, hypoxia and acidity which are essential for stemness maintenance and regulation. Opportune activation of the MICs via fusion with bone marrow stem cells triggers a frenzy of cellular proliferation and sets them on the move again.  This scenario is akin to oocyte fertilization in the Fallopian tube and its subsequent journey towards the decidum.  Just as the human reproductive process is plagued with undesirable outcomes so is the cancer metastasis highly inefficient.  The climax of the cancer metastatic drama (colonization) is reached when proliferating MIC clusters attempt to settle down on decidum-like premetastatic sites.   Successfully colonized clusters blossom into overt macrometastases only after the execution of sophisticated immunomodulation, angiogenesis and vascular remodeling.  Similarly, the implanted blastomere needs to orchestrate these feats before flourishing into a new life.  What is more, the cancer reproductive drama seems to be directed by a primordial Hypothalamus -Pituitary -Gonad axis. Pursuing this reproductive trail could lead to new frontiers and breakthroughs in cancer research and therapeutics. 

Biography:

Mohsin Shaikh has completed his MD from M.S. University, Gujarat and postgraduate studies from AAPS Toronto. He is a lead clinical data manager at Axiom Real-Time Metrics, a premier clinical data management service organization providing expert solutions into the EDC/DM/IWRS sector. He has published more than 15 papers in reputed journals and has been serving as an editorial board member of Repute. Mohsin is an international medical graduate with more than 8 years of experience in Clinical Research Industry mainly in Clinical Data Management. 

Abstract:

An Effective eCRF design is always key to the successful outcome of a clinical trial.

The main objective is to offer improved data quality, online discrepancy management, faster database lock and at the same to time preserve and maintain quality and integrity of the data. eCRF design should be standardized to address the needs of all user roles enrolled within the Clinical Trials. Data should be organized in a format that facilitates and simplifies data analysis for submission. Review of the primary and secondary study end points as well as well-planned study design and safety/efficacy outcomes will assist the process of effective eCRF designing. Use of CDISC standards variables will also enhance the process of effective eCRF building. Effective measures taken while conducting eCRF design as well as post production changes (changes deployed on production environment of the eCRF design) will result in reduced query generations and improved data integrity. This presentation will also describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

Biography:

Thiago M. Sakae has completed his PhD at the age of 32 years from Federal University of Santa Catarina, South Brazil and postdoctoral studies from University of Southern Santa Catarina – UNISUL, Brazil. He is the anesthesiologist and epidemiology professor at UNISUL, an University in Southern Brazil. He has published more than 130 papers in reputed journals and has been serving as an editorial board member of repute. 
 

Abstract:

Objective: The purpose of this study was to evaluate the effect of intravenous or perineural dexamethasone added to ropivacaine on the duration of ultrasound-guided interscalene brachial plexus blocks (BPB).

Methods: Randomized Clinical Trial. Setting, Patients and Interventions: Sixty ASA physical status I−II patients with elective shoulder arthroscopic surgeries under interscalene brachial plexus blocks were randomly allocated to receive 20 ml of 0.75% ropivacaine with 1 ml of isotonic saline (C group, n = 20), 20 ml of 0.75% ropivacaine with 1 ml (4 mg) of perineural dexamethasone (Dpn group, n = 20), or 20 ml of 0.75% ropivacaine with 1 ml of isotonic saline and intravenous 4 mg dexamethasone (IV) (Div group, n = 20). A nerve stimulation technique with ultrasound was used in all patients.

Measurements: The onset time and duration of sensory blocks were assessed. Secondary outcomes were pain scores (VAS) and postoperative vomiting and nausea (PONV).

Results: The duration of the motor and sensory block was extended in group Dpn compared with group Div and group C (P＜0.05). In addition, within 24 h, group Dpn presented lower levels of VAS and lower incidence of PONV as compared with the other groups. Moreover, there was a significant reduction on onset time between group Dpn and the other groups.

Conclusions: Perineural 4 mg dexamethasone was more effective than intravenous in extending the duration of ropivacaine in ultrasound-guided interscalene BPB. Moreover, Dpn has significant effects on onset time, PONV, and VAS.

Biography:

Diana is a consultant to the Society for Clinical Research Sites as their Vice President of Strategy and Development and in that role is responsible for building relationships with industry that help amplify the voice of the clinical research site. Diana has addressed audiences across five continents, published multiple papers and articles, and written five authoritative industry books including global issues in patient recruitment and retention, the highly anticipated sequel to international patient recruitment: Regulatory guidelines, customs and practices. The books serve as teaching tools for colleges and universities, along with her earlier works: A guide to patient recruitment, a guide to patient recruitment and retention and 50 ways to cope with arthritis. Her personal honors include recognition by the Global EXEC Women’s International Council as a 2009 International Woman of Influence, being named a finalist for Ernst and Young’s Entrepreneur of the Year Awards in 2008, and an induction into the 2006 PharmaVOICE “100 Most Inspiring People in the Life-Sciences Industry.

Abstract:

Biography:

Joann Pfeiffer completed her Doctorate of Science, in Regulatory Science from the University of Southern California. She is currently the Director and an Associate Professor, in the Clinical Research Managment Graduate Program at Arizona State University. She has published several books related to managing contracts and budgets in clinical trials, conducting clinical trials at study sites, as well as articles in peer reviewed journals. Her expereince includes over 20 years in the management of clinical trial operations in both academic and non-academic settings. 

Abstract:

Biography:

Colleen is the CEO of Objective Clinical which is a clinical research strategy and management firm located in the Nashville Tennessee area that supports clinical research leaders in strategic and financial planning, regulatory compliance and optimization of research operations. She brings 25 years of experience in development, management and operational direction of clinical research organizations. She has held senior positions with international clinical research organizations (CROs) including specialty CROs. She served as a committee member for International Business Communications on their Speakers Board for healthcare administration topics, as a Biotechnology Advisory Member for Bates Technical College in Tacoma Washington, and a Board of Director member for Seattle’s Children’s Home. She has been a presenter at ACRP. Colleen is a graduate of the University of Tennessee, College of Business.

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Biography:

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