Biography:

Trials.ai is Kim’s 3rd company yet her passion for fixing logistical problems with clinical trials drives her as if it were her first. Her expertise in organizational development enabled her build Corporate Development Programs for companies like Pfizer, Merck and Wyeth Ayerst. Ms Walpole understands the complex clinical trials space and the needs of sponsors, CROs and sites. Her goal is to use technology to as a catalyst for helping organizations in study design and execution so that patients can be exposed to better quality treatments, faster.

Abstract:

The synergy of advances in diverse areas of artificial intelligence holds considerable promise for improving the efficiency and efficacy of clinical trials. Of particular interest to Trials.ai is improving the design and execution of protocols. Poorly constructed protocols lead to poor research and costly amendments, protocol deviations, delays in obtained appropriate data and more.

Opportunities for Artificial Intelligence to Improve Outcomes

The Trials.ai system is designed to accept a protocol document, scan it and assess for opportunities and threats. This includes, for example, consistency between the time and events (T&E) table and the in-text description of events, and consistency between the synopsis and the body of the protocol. Natural language processing tools are helpful in this regard. Additionally, AI tools are used to scan completed protocols based on a similarity. Similar protocols coupled with published and internal data are mined to predict the degree of success from the proposed design as well as identify any problematic items.

Addressing Enrollment and Retention

Clinical trials often fail because of poor enrollment. Trials.ai can warn the study designer, for example, that particular inclusion/exclusion criteria may be too limiting for subject enrollment can save the sponsor considerable funds and time that can be invested in a better clinical design or an alternative effort. Clinical trials also fail because of poor subject retention. To address this, we have created and are refining what we call a Patient Burden Index (PBI), which is an AI-derived quantitative measure of the impact that the protocol design has on the subject. Protocols can then be scored based on their PBI, and alternative designs can be explored. We believe this is an entirely novel approach to improving subject retention and cooperation at all stages of a clinical trial.

Executing the Trial More Effectively and Efficiently

Once the trial has started, AI will play additional roles to help ensure a best outcome. In our case, our client partners provide a protocol that is uploaded into our system. The system then maps the T&E schedule into a dashboard-driven user interface that shows when each event is to be completed. With available personnel assignments and schedules, the system can also identify who is to do which task in support of which patient at which time. Practitioners are alerted ahead of time for events, which helps to reduce protocol deviations. 

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:

Complete, accurate and consistently coded datasets are continuously required for study analysis and its impact on the study results. Many times, in multicentric clinical trials, investigator(s) or medically qualified experts are from sites or centers across the globe, involved in recording the clinical term(s) uniformly is a big challenge. Medical coders from Clinical Data Management Teams process these clinical terms and perform medical coding. Medical coding is performed to categorize the clinical terms reported appropriately so that they can be analyzed/reviewed using either Traditional or New Coding Models via MedDRA and WHO Drug dictionaries. Understanding the process of medical coding and the workflow including dictionary up-versioning will positively impact the outcome of the study significantly. Medical Coders always work closely with the Clinical Data Manager to assist the Query Management Process and address critical variable data points. Coded data transfer analysis predicts the trend of the primary end point variables and its outcome. This presentation will highlight the whole process, common problems and its resolution while executing the process of clinical coding.

Biography:

Efe Egharevba is a final year part-time PhD student at Glasgow University’s Institute of Health and Wellbeing. He completed a Master’s degree in Clinical Research at Cardiff University’s Welsh School of Pharmacy in 2008 and obtained a Bachelor degree in Biology from the University of North Texas. He has spent 13 years working for various pharmaceutical companies in clinical operations, overseeing the conduct of clinical trials around the world. 

Abstract:

Clinical trials still represent the gold standard in testing the safety and efficacy of new and existing treatments. However, developing regions including sub-Saharan Africa remain underrepresented in pharmaceutical industry sponsored trials for a number of reasons including fear of corruption and unethical behaviour. This fear exists both on the part of pharmaceutical companies, and investigators carrying out research in the region. The objective of this research was to understand the ethical considerations associated with the conduct of pharmaceutical industry sponsored clinical trials in sub-Saharan Africa. Corruption was identified as a significant issue by a number of stakeholders who participated in semi-structured interviews and completed questionnaires. Additionally, fear of being perceived as corrupt or unethical even when conducting ethically sound research was raised as a concern. Thus corruption, whether actual or perceived, is one of a number of issues which have precluded the placement of a greater number of pharmaceutical sponsored clinical trials in this region. More discussion around corruption with all relevant stakeholders is required in order for progress to be made and to enable greater involvement of sub-Saharan African countries in the conduct of industry sponsored clinical trials.

Biography:

Oladapo M Olagbegi has completed his PhD from University of Ibadan, Nigeria. He is currently pursuing Post-doctoral studies at Rhodes University, Grahamstown, South Africa. He has published more than 10 papers in reputed journals.

Abstract:

Background: Effects of combined kinetic-chain exercises on physical performance and quality of life in knee osteoarthritis (OA) has not been reported. This study was designed to investigate and compare the effects open, closed and combined kinetic-chain exercises (OKCE, CKCE and CCE) on performance-based physical function and health-related quality of life (HRQoL) of patients with knee OA.

Method: The randomized clinical trial involved ninety-six consecutive patients with knee OA who were randomly assigned to one of OKCE, CKCE or CCE groups. Comfortable and fast pace walking time (CPWT, FPWT) and HRQoL were assessed using a stopwatch and Arthritis Impact Measurement respectively at baseline and at the end of weeks 4, 8 and 12.

Results: The groups were comparable regarding their demographic and dependent variables at baseline; there were no significant intergroup differences in CPWT, FPWT and HRQoL at the end of weeks 4, 8 and 12. CCE group (-2.38±2.52 s) however demonstrated significantly higher mean change in CPWT than either OKCE (-1.31±1.03 s) or CKCE group (-1.44±1.19 s) between baseline and week12. Walking times and HRQoL scores significantly reduced across all-time points of the study indicating improvement for all measures.

Conclusion: Combined kinetic-chain exercises are more effective than either OKCE or CKCE alone for improvement of physical performance in knee OA. 

Biography:

Luciana Ximenes has completed her PhD at the age of 31 years from Federal University of Ceara. She is a Professor of General Pathology at the Unichristus University Center in Fortaleza, Ceara, Brazil. He has published more than 10 papers in reputed journals and has been serving as an editorial board member of repute. Her research on depression with citronellyl acetate received an honorable mention at the Symposium on Medicinal Plants in 2012.

Abstract:

The citronellyl acetate is a monoterpene present in the essential oil of various plants with citronella. Studies have shown its activity as anti-inflammatory, antimicrobial substance analgesic, antioxidant, and being their biggest use in veterinary as insect repellent.The present study investigated the antidepressant activity in mice in the experimental tests the forced swimming and tail suspension test as well as the involvement of the monoaminergic system in these effects. Citronellyl acetate reduced the immobility time in the forced swimming test and tail suspension test, at doses of 50 and 100 mg/kg, p.o. The anti-immobility effect of citronellyl acetate (50 and 100 mg / kg) was reversed by pretreatment with PCPA 100 mg/kg i.p. (inhibitor of serotonin synthesis), Prazosin 1 mg / kg, i.p. (α-1 adrenoceptor antagonist), Yohimbine 1 mg / kg, i.p. (α-2 adrenergic receptor antagonist), SCH233390, 15 mg / kg, s.c. (D1 dopamine antagonist) sulpiride 50 mg / kg, i.p. (dopamine D2 antagonist). The analysis of the levels of monoamines showed an increase in the levels of monoamines (NA, DA and 5-HT) at a dose of 100 mg/kg of citronellyl acetate and the dose of 50 mg/kg increased levels of NA in striatum of mice. Thus, the study suggests that the anti-immobility effect of citronelila acetate in the forced swim test is related to its action on adrenergic, dopaminergic and serotonergic receptors, which was evidenced by an increase in the levels of monoamines in the brain, suggesting a possible antidepressant effect of this substance. 

Biography:

Dr. Rahul A. Hajare has expertise in HIV Drug Technology, Computer Chemistry, Binding Energy, Thermodynamics, Physical Chemistry, Biological Development, Vaccine, Model speeds drug discovery, Molecular modelling Drug Design, Synthesis and QSAR, Impurity trends. Dr. Hajare is a post-doctoral fellow 2013 (7 th Batch) funded by the Indian Council of Medical Research, New Delhi, under the guidance of Hon’ble Dr. Ramesh Paranjape, Former Director & Scientist ‘G’ National AIDS Research Institute Pune He is a member of ACS, AAPS, Biomaterial Society, OMICS International and CVC Government of India.

Abstract:

ART drug are widely used Anti-HIV agents. Of these, molecular recognition in their molecular nucleus likes diarylpyrimidine, benzoxazinone, heterocyclic most present in ART. Apart from these, some hetero atom along with some special core group have been reported, They are effective and not very costly, though there are also possibilities of ART adverse reactions common with use of ART. Cross reactivity between for example etravirine and rilpivirine, earlier reported may exceed 30%. Common adverse drug reaction for highly protein bound ART, includes hypersensitivity reactions were characterized by rash, fever and sometimes organ involvement including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and eosinophilia. Adverse drug reactions caused by drugs belonging to no longer their therapeutic effect or alter their adverse events profile. Hence, this study has undertaken to promote health care setting, so researcher movement initially began inside hospitals and clinics. This study adverse drug reaction has setting drug discovery in HIV technology in collaboration with microbiologist, physicians, pharmacist, nurse practitioners and other healthcare professionals then there is adverse reactions could have been prevented or may lead to zero adverse reaction ART. Also this study has shown of critical analyzing the clinical profile of these reactions, grading them and trying to figure out ways to deliver actual drug discovery to prevent these adverse reactions. Reports were messaged to see clinical pharmacist stating explicitly that the clinical pharmacist cares for patients in all health care settings emphasizes two points: that clinical pharmacist provides care to their patients and that this practice can occur in any practice setting. The study aims to assess the role of clinical pharmacist in identification and reporting of adverse drug reactions in antiretroviral therapy and consideration of new pattern clinical study.

Biography:

Victor Ngu Ngwa has completed his PhD from the University of Camerino School of Biosciences and Veterinary Medicine, Italy, and MSc (Pathology) from the Swedish University of Agricultural Sciences, Uppsala. He is a Senior Lecturer and the current Head of Microbiology and Infectious Diseases Department of the University of Ngaoundere School of Veterinary Medicine and Sciences. He has published more than 16 papers in reputed journals and has been serving as a reviewer in quite a number of peer-reviewed journals. 

Abstract:

The aims of this work were to evaluate the potential role of enrofloxacin in controlling the severity of the clinical mastitis in sheep caused by Staphylococcus aureus; to improve cure rates and to minimize the related effects of the disease on the mammary glands. This study was conducted in commercial dairy flocks, where there was ongoing intensive monitoring of subclinical mastitis by Somatic Cell Count (SCC) and bacteriology. Two groups of animals were selected from these flocks. Group A (n=34 animals) and Group B (n=39 animals) were treated with 2.5 mg/kg bw and 5 mg/kg bw, respectively of enrofloxacin (Baytril®5% injectable solution, Bayer, Italy) for three consecutive days (two doses per day). The effectiveness of the enrofloxacin in curing the S. aureus-induced clinical mastitis was monitored through SCC, rectal temperature, and by systemic and local mammary gland reactions from the 1st to the 14th day post treatment. The presence of S. aureus in milk samples was confirmed by bacteriological examination and PCR before and after treatment. Bacteriological cure was 39% in Group A and 82% in Group B. Both doses significantly reduced SCC (P<0.001), while the reduction in Group B was also significantly higher than Group A. Mean rectal temperature as well as local mammary gland and systemic reactions, also decreased significantly in both groups (P<0.001). In conclusion, both enrofloxacin concentrations provide bacteriological cure but the higher concentration resulted in greater reduction of clinical mastitis in sheep caused by S. aureus.

Biography:

Etsubdink Abera Aboye earned his Medical Doctorate Degree from St. Paul’s Hospital Millennium Medical College in Ethiopia, in November 12, 2013. He graduated with distinction and retained in the Medical College with academic rank of Lecturer and Early Career Researcher. He has participated in various researches that brought positive change to the community, and he is currently participating on ‘the evaluation of a Standardized Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB,’ multicenter trial involving five Hospitals in the City. He worked as President of the Medical Students’ Association, Assistant Student Dean, Modular Coordinator, and Undergraduate Students’ Coordinator. He is currently a fellow at Harvard Medical School-Global Clinical Scholars Research Training Program with Clinical Trial Concentration, and member of Research Ethical Review Committee of his academic Institution since 2016.

Abstract:

Clinical trials in Ethiopia and other developing nations can generally be considered to be in its embryonic stages. The share of studies registered from Africa (in Clinicaltrials.gov) updated as of June 2017 is only 0.025%, although the region represents about 15% of the population of the world; and Ethiopia represents only 1.5% of all the studies from Africa.

Though clinical trials provide the highest degree of evidence to support new interventions and decisions about disease management, the challenges of conducting clinical trials in Ethiopia are enormous. The basic problem arises from the country’s poor economy that resulted in underdeveloped research infrastructure such as space, supplies and maintenance affecting clinical work, communication, access, availability of basic needed inputs, and lack of trained workforce in clinical research.

Besides, there is lower prioritization of research in academic institutions considering research as a luxury; time and money consuming; and this has resulted in the establishment of very few clinical trials units nationwide. There is lack of equitable incentives for researchers due to limited sources of funding and very minimal budget allocation to clinical research activities by the government. The regulatory frameworks are also bureaucratic; and this has been discouraging to the few clinical researchers resulting in brain drain; that is a challenge in health facilities in resource-limited settings as it is associated with increasing workloads, lowering the quality of services, reducing team efficiency and causing a loss of institutional knowledge.

Moreover, poor and/or illiterate study participants and differing cultural values and beliefs may lead to recruitment, consent and follow up difficulties, which slow down trial progress from my experience in Ethiopia.

Biography:

Ming Hong is a year four PhD student at the University of Hong Kong. His researches are mainly focus on Chinese medicines and liver diseases.

Abstract:

Liver injury caused by hepatotoxic agents is a major health problem that challenges not only health care professionals but also the drug regulatory agencies and the pharmaceutical industry in recent years. Traditional Chinese herbal medicines such as Xiao chai hu tang (XCHT) and Heshouwu are widely used for chronic liver diseases and generally regarded as safe due to their extensive clinical use. However, in recent years, there have been increased clinical case reports regarding the long-term hepatotoxicity risks of these two hepatoprotective Chinese herbal medicines in patients with liver dysfunctions. Herein, based on the network pharmacology framework, we analyzed the potential hepatotoxicity of XCHT and Heshouwu by predicting the hepatotoxic ingredients and identify the molecular targets of hepatotoxicity in XCHT and Heshouwu. As a result, two drug-target networks of hepatotoxicity of XCHT and Heshouwu were constructed and analyzed through network pharmacology assays. This network pharmacology research on herbal hepatotoxicity may provide a forceful tool for exploring the potential toxic ingredients and related intracellular mechanisms of Chinese herbal medicines. However, further experimental verification of the potential hepatotoxicity compounds is needed to validate the accurate interactions between these herbal ingredients and protein targets predicted by the in-silico method.

Biography:

Nasreen Akhtar has completed her PhD in Biotechnology in 2017 from Indira Gandhi National Open University with collaboration of National Institute of Malaria Research, Delhi, India. Currently, she is working on Zika virus and she has two published papers in reputed national journals.

Abstract:

Zika virus is an emerging mosquito-borne flavivirus that was first identified in Uganda in 1947 in Rhesus monkeys through a network that monitored yellow fever. It was later identified in humans in 1952 in Uganda and the United Republic of Tanzania. Outbreaks of Zika virus disease have been recorded in Africa, the Americas, Asia and the Pacific. From the 1960s to 1980s, human infections were found across Africa and Asia, typically accompanied by mild illness. The first large outbreak of disease caused by Zika infection was reported from the Island of Yap (Federated States of Micronesia) in 2007. In July 2015 Brazil reported an association between Zika virus infection and Guillain-Barré syndrome. In October 2015 Brazil reported an association between Zika virus infection and microcephaly. In 2017, Angola reported two cases of Zika virus. In 2017, the Ministry of Health and Family Welfare-Government of India (India) reported three laboratory-confirmed cases of Zika virus disease in Bapunagar area, Ahmedabad district, Gujarat state, India. India needs to be particularly proactive on zika spread since the mosquito that carries the virus actually thrives in the country. Zika virus is primarily transmitted to people through the bite of an infected mosquito from the Aedes genus, mainly Aedes aegypti in tropical regions. Aedes mosquitoes usually bite during the day, peaking during early morning and late afternoon/evening. This is the same mosquito that transmits dengue, chikungunya and yellow fever. Six zones of Delhi, India were selected for entomological surveys in transmission and non-transmission seasons. Study sites were selected on the basis of occurred dengue cases in Delhi and near about localities and these localities categorized into high, medium and low income groups on the basis of socioeconomic characteristics of the resident population. A total of 139 localities of Delhi were surveyed and larvae were collected from different breeding habitats like, cemented tank, bird pots, storage tank etc. A total of 2618 mosquitoes in 348 pools (10 mosquitos in one pool) were processed for the isolation of RNA and screened by RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) and it was found that 10 localities in Delhi namely, Mahipalpur village, Raj Nagar (Dwarka), Laxmibai Nagar, Tagore Garden, Bagdola village (Dwarka), East Kidwai Nagar, Bharthal village (Dwarka). Madhu enclave (Najafgarh), Brijpuri (Shahdara) and Nehru vihar (R K Puram) were found positive for dengue virus but all were negative for zika virus. Presently no specimen was found positive for zika virus in Delhi, India.

Biography:

Liora Bosch, has been working at Omrix as a biostatistician for the past 4 years and has broad-based experience in study design and data analysis. In her former role, Liora filled the position of a clinical data manager, overseeing multisite clinical trials across the US and EU. In that capacity, Liora worked with leading and cutting edge EDC systems and conducted training for system users. In parallel to her work, Liora is pursuing a master's in biostatistics. As part of her thesis, Liora provides statistical support and analysis for an upcoming clinical trial. Her thesis work is mentored by a fellowship of Tel-Aviv University and Harvard University. 

Abstract:

Worldwide, in the past few decades the emerging incorporation of electronic systems has accelerated rapidly. We witness many official services; like banking or government services, and others like shopping or even gambling that have moved on-line, yielding huge efficiency gains for suppliers along with improved customer experience. The question that we should ask is "Where does the clinical trials industry incorporate in that sense?" or, being more specific, "How does the implementation of an EDC system affect the clinical trial working procedures?"

We will start by reviewing the FDA prospective on eSource as a means of clinical data collection followed by examples of electronic data originators. Then continue by giving an overview of the modified data collection and handling procedures and presenting the existence of data element identifiers driven by EDC deployment. When considering EDC implementation there are still barriers to be overcome, all of which can be categorized into the following: high upfront cost, lack of technical knowledge and resistance to change.

On a personal note, in my lecture I will try to address these issues by presenting the available types of EDC systems in the market today. Trying to address the economic considerations via a case study describing a full EDC implementation. In addition, the two last sections will be dedicated to the importance of statistical knowledge when designing an eCRF. Finally, I will conclude by intriguing future availabilities in terms of statistical process control. Incorporating such controls into the EDC system could detect real time unusual data variations and deprive the loss of statistical power.

Biography:

Amanda Brock has completed her Master of Bioethics and Master of Science in Nursing at the University of Pennsylvania. She has ten years’ experience in direct patient care including inpatient and outpatient, nursing administration, and clinical research.  She is experienced in leading committee work and creating nursing policies. She is a firm believer in systems thinking and the importance of clear and thoughtful communication in clinical care.

Abstract:

Integration of Palliative Care into oncology care has been a challenge since the inception of palliative care programs. Phase 1 oncology clinical trial participants are considered a distinctly vulnerable population. They are at high risk for lack of follow through by the healthcare system after being withdrawn from the clinical trial. In addition, they are at risk for therapeutic misconception and major challenges associated with dual enrollment on the trial and hospice programs. Patients with dual enrollment in palliative care and phase 1 trials could live longer lives, remain on trials for longer, have higher rates of advance directive completion, and may be more likely to die comfortably at home.  Palliative Care consultation upon Phase 1 trial enrollment can could improve the quality of the research being conducted as well as improve Quality of Life for trial participants.

Biography:

Francesco Piacenza has completed his PhD at the age of 29 years at the Polytechnic University of Marche. He continued the research activity on age related diseases by leading the postdoctoral studies at the National Institute of Health and Aging. In 2011, he also acquired the title of Clinical and Epidemiological Research Coordinator at the same Institute. He is actually a Specialist in Clinical Biochemistry at the National Institute of Health and Aging in Ancona, Italy. He has published more than 40 papers in peer-reviewed journals with impact factor and is an editorial board member of various journals.  

Abstract:

Oral anticoagulation therapy (OAT) with coumarins (vitamin K antagonist) is the most used against thromboembolism. Prothrombin time International Normalized Ratio (PT-INR) monitoring is fundamental to determine coumarins dosage and prevent bleeding complications or thrombotic events. In this contest, the method used for providing the INR measurements is crucial. Several studies measured both PT-INR precision and accuracy of the most known mobile coagulometers. However, no data on the new XPrecia Stride Mobile Coagulometer (Siemens) are available in literature. The aim of this work is to analyze precision and accuracy of the new XPrecia Stride mobile coagulometer to provide recommendations for clinical use and quality control.

A total of 163 patients (mean age = 77.4 years old) under Warfarin OAT for whom the INR was assessed by both the traditional cs 2100i Sysmex and the new Xprecia Stride Mobile Coagulometer were included in this study.

The precision of the new mobile coagulometer resulted very good (CV < 3%). The analytical accuracy was also in line with other known devices (MRD = 6.78%). Finally, the clinical accuracy was acceptable (deviation > 15% from the true value in 20% of cases). Considering the overall results obtained by the new Xprecia Stride in comparison to that ones obtained from the other commercial devices, we can conclude that the new coagulometer is enough reliable for clinical settings. However, a larger trial to confirm these data is needed.

Biography:

Born in Mexico City, Moses Zonana moved to the U.S. to obtain his B.A. in Mathematics from Rutgers University. He earned his MBA in 2005 from Harvard Business School with academic honors. Zonana has more than 15 years of executive-level experience, where he used his diverse expertise in healthcare, telecommunications and technology to develop the health technology solutions provider, Compliance Meds Technologies (CMT). During his tenure as CEO of a regional mail-order pharmacy, Zonana recognized that the industry was simply supplying and refilling medications without knowing patients’ adherence to dosing regimens. He envisioned CMT as a solution to improve patient outcomes

Abstract:

Pharmaceutical manufacturers have long struggled to create an efficient clinical trial process for faster next phase approval. The root cause of most failures is a lack of necessary efficacy data to support clinical trial claims. Subpar data can be directly tied back to an inability to track and report on patient adherence to drug protocol. Patient adherence is critical to the outcome of clinical trials in determining the drug’s efficacy, establishing dosing guidelines, and receiving market approval. Compliance Meds Technologies (CMT) offers a novel approach to medication tracking during clinical trials with its patented CleverCap devices that track and record real-time dispensation of oral solid medications in the outpatient setting. CMT’s robust cloud-based platform captures detailed dosing logs, enables timely screening and empowers enrichment interventions. CMT’s platform presents data in ways that allow sponsors and CROs to benchmark sites and shed light to investigators regarding correlations between dispensation dosing patterns and efficacy. CMT’s technology is applicable across different phases in research and development: Phase II-IIIb studies, where the participant is not taking the medicine in someone’s presence; PK sampling studies not dosing in clinic, where the exact time that a subject took a dose prior to PK sampling is critical; Protocols that call for complex dosing schedules; Studies that require titration or adaptive studies; Studies in high toxicity therapy classes and narrow PK profiles (e.g. Cancer, Hepatitis C, CNS – MS, ALS, Parkinson’s); Therapy classes with concerns of overdosing or when the study medicine is prone to diversion (e.g. Opioids).

Biography:

Jing Bao is a Medical Officer at the division of AIDS, National Institute of Allergy and Infectious Diseases, Columbus Technologies and Services, Inc. with extensive experience in international clinical trial oversight and global regulations. She manages and oversees the US government (National Institutes of Health) funded/sponsored international multi-center clinical trials on treatment development for HIV/AIDS and co-infections. She received her MD from China and was a Medical Director for two hospitals before she received a PhD from Israel. She has published influential research findings in world leading journals. She is the Member of Asian American Executives Network and will be graduated from its Senior Executive Service Candidate Development Program in April 2017. 

Abstract:

As the rising economic superpower in the world, China is now striving to be at the forefront of clinical research and drug development. There are many advantages to conducting clinical trials in China including large patient populations, a large and growing network of hospitals qualified to conduct high standard clinical trials, skilled clinical trial and laboratory professionals and project leaders, strong support from the government for international partnerships, improved regulatory environment for clinical trials and new drug approval, and strong enthusiasm for international collaborations. However, several challenges remain, such as large migrant populations, language and cultural differences, and the uncontrolled use of traditional Chinese medicine. Timely importation of study agents is one other significant challenge. Quality control is the key to ensure clinical research projects meet the highest standards. The recent changing drug regulatory landscapes have also brought attention and galvanized international companies that intend to conduct drug trials in China.

       This workshop, using the real examples, will present and discuss the advantages and challenges of conducting clinical trials in China. The pitfalls to avoid and possible solutions to conducting high quality clinical trials in China will be emphasized.