The COVID-19 pandemic, out of necessity, has dramatically altered the way clinical trials are being conducted, ushering in a new era of more diverse, patient-centric, digitally connected trials and boosting the acceptance and use of real-world evidence. This shift has presented challenges, but also offers numerous benefits for both trial participants and study sponsors, and it could result in a sea change that persists long after the pandemic is gone.
To gain a better understanding of the multiple forces impacting clinical trials today—and how FDA and other regulatory agencies have helped move the needle—Market Pathways recently spoke with Isaac Rodriguez-Chavez, PhD, SVP, Scientific and Clinical Affairs, PRA Health Sciences Inc. Rodriguez-Chavez is a leading expert on clinical trial modernization, with more than 32 years of experience in the healthcare research and regulatory fields, most recently as a Senior Officer for Clinical Research Methodologies, Regulatory Compliance, and Medical Policy Development at FDA’s Center for Drug Evaluation and Research. At CDER, he led the development of guidance around decentralized clinical trials using digital health technologies, with the goal of modernizing clinical research protocols. In November 2020, he joined PRA Health Sciences, a leading worldwide contract research organization (CRO), as SVP, Scientific and Clinical Affairs and head of the company’s Global Center of Excellence for Decentralized Clinical Trial Strategy.