Clinical Trial Podcast | Conversations with Clinical Research Experts

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? Should a Sponsor get access to patient data collected outside a clinical trial setting? To answer these questions and more, I invited Darshan Kulkarni to the show. Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker. He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health. He serves on the editorial board for Applied Clinical Trials at Advanstar Communications serving as a legal advisor on the clinical trial industry.  Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise. Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry. This podcast is brought to you by Florence Healthcare. The learn more, please visit florencehc.com  

In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants.  In other words, the success rate was 21%. And the total funding amount was $8,827,444,624. The question I had was, “What does it take to get grant approval and launch an NIH funded research project?” To answer this question, I invited Dr. Manish Shah,  Professor of Pediatrics at Baylor College of Medicine and Attending Physician in the Texas Children’s Hospital Emergency Center in Houston.  Dr. Shah has served on several national committees to advocate for improvements in pediatric and prehospital emergency care.  His research has focused on developing, implementing, and studying outcomes related to evidence-based protocols for various clinical conditions, including seizures.  Dr. Shah is currently the Principal Investigator for the Pediatric Dose Optimization for Seizures in Emergency Medical Services (PediDOSE) study, which has been funded by the National Institute of Neurological Disorders and Stroke (NINDS) and is being conducted in the Pediatric Emergency Care Applied Research Network (PECARN). Please join me in welcoming Dr. Shah on the Clinical Trial Podcast.  This episode is brought you by Florence Healthcare. To learn more, please visit https://florencehc.com/

A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research finances, it can end up costing you a lot of money in the long run.  To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between cash and accrual based accounting, and more,  I invited our guest, Kristi Etchberger, on the show.   Kristi founded Clinical Research Billing in 2015 to help independent research sites manage their CTMS and generate cash flow through invoicing and collections. After nearly seven years, she and her partners have built Clinical Research Billing into a successful, growing small business. Kristi served as Chief Executive Officer of Atlantic Clinical Research Collaborative in Palm Beach County, Florida, where she oversaw the implementation of a clinical trial management system.  Kristi is an experienced corporate executive with a background in corporate finance and international equity markets.  Kristi received her M.B.A. in finance from The Wharton School at the University of Pennsylvania, B.A. in economics and psychology from Pitzer College, Claremont, California, and the Chartered Financial Analyst designation from the CFA Institute.  She studied pharmaceutical law at Seton Hall University. Please join me in welcoming Kristi on the show. This poodast is brought to you by Florence Healthcare. To learn more, please visit https://florencehc.com/.  

In this insightful discussion, Ryan Jones, CEO of Florence Healthcare, shares his expertise on the evolution of software solutions in clinical research. He talks about how workflow automation and specialized tools are transforming site operations and enhancing participant engagement. Ryan highlights the challenges faced by large academic centers versus smaller sites in adopting new technology. Additionally, he emphasizes the importance of a supportive company culture and book recommendations that inspire innovation within clinical research.

Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB.  Previously she served as senior vice president, research, at the Brigham and Women’s Hospital for 11 years, and was the institutional official for human and animal research, for biosafety, and for research integrity.  She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. In addition, she was the Founding Director of the Center for Faculty Development and Diversity at the BWH. In addition to her academic responsibilities, she currently serves on the Board of Directors of Vivli, Inc., a non-profit organization founded by the MRCT Center dedicated to global clinical trial sharing; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research.  Previously she has served as the chair of the Board of Directors of the Association for Accreditation of Human Research Protection Programs (AAHRPP), on the Board of Public Responsibility in Medicine and Research (PRIM&R), and as chair of the Secretary’s Advisory Committee on Human Research Protections, HHS. She has authored or co-authored over 240 publications and has served on the editorial boards of a number of journals including Current Protocols of Immunology, Blood, Therapeutic Innovation and Regulatory Science, Ethics and Human Research. Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School. Please join me in welcoming Dr. Barbara Bierer on the Clinical Trial Podcast.  This episode is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/

Discover reasons for patient recruitment failure in clinical trials from an investigator perspective, such as funding deficiencies, logistical obstacles, and competing trials. Learn about challenges like burdening procedures, narrow eligibility criteria, and administrative constraints. Explore strategies to break into the clinical research field without prior experience and incentivizing site personnel for patient enrollment.

Clinical trials are conducted in compliance with regulations.  Simply stated, you need a clinical and regulatory strategy when it comes to conduct of clinical trials for medical devices. As a clinical researcher, there have been times I’ve felt lost because I did not understand the regulatory framework. To close this knowledge gap, I thought it would be great to invite Priya Jagasia, Divisional Vice President (DVP) of Regulatory Affairs at Abbott Vascular on the show. In this episode, Priya shares with us her experience and knowledge on regulatory affairs, specifically focused around medical device regulations in the United States. She does a great job of tailoring our conversation to make it applicable for clinical trial professionals. We cover topics such as working with the FDA, partnership between regulatory affairs and clinical research, career and professional development, and much more. The art and science of regulatory affairs is fascinating and there is no better person on the planet who can educate us on this topic. Please join me in welcoming Priya Jagasia on the Clinical Trial Podcast. Podcast Sponsor: This episode is brought to you by Florence Healthcare. To learn more, visit florencehc.com