Clinical Trial Podcast | Conversations with Clinical Research Experts

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

The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we’re headed in the right direction.  The change in turn has led to an increased focus on decentralized clinical trials (DCTs).  But what exactly is a DCT?  To learn more, I invited Derk Arts, Founder & CEO of Castor.  Derk has over fifteen years of experience in medicine, research and technology.  His company, Castor, provides useful technology for sponsors and sites to conduct decentralized clinical trials.  What is great about Derk is that he is a physician by training and now runs a clinical trial software company.  At a micro level, Derk understands the tools a doctor needs to provide optimal patient care in a clinical trial setting.  At a macro level, Derk can see what it takes to conduct a clinical trial with multiple sites/ patients and how technology can solve such complex problems.  This was a fun interview for many reasons.  Derk talks about the future of Electronic Data Capture (EDC), his thoughts on what it means to run a decentralized clinical trial, most misunderstood aspects of DCTs, Castor’s company culture, his favorite books, honey bees, and much more.  I hope you enjoy this conversation with the all amazing Derk Arts on the Clinical Trial Podcast. This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/.