“We’re seeing significant innovations in the medical product development industry, and true innovation can cause some consternation in such a highly regulated sector,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, at the U.S. Food and Drug Administration (FDA). “Yet, innovation is central to progress in clinical research, helping advance products for unmet medical needs and improve medical practice.”
“We need to have open conversations about all elements of medical product development that are currently in flux and what these changes mean to clinical trial stakeholders,” asserts Burrow. “Stakeholders do not operate in isolation. The need to generate reliable data is a shared cornerstone for us all. Our call to action is for us to look with open eyes and ask what is in our shared interests to drive efficiency and transparency in clinical research design and operations.”
“Sophisticated technologies can be harnessed to shift mindsets and enable better use of our time” notes Burrow. “We need to find alignment in shared roles and responsibilities across the clinical ecosystem. This will ensure that we generate reliable, high-quality data to protect the safety of study participants and patients who ultimately use marketed medical products.”
Join David at ACRP 2024 [May 3 – 6; Anaheim, Calif.], for a Signature Series session as he shares perspectives on various clinical trial innovation activities, including evolving study designs, operational approaches, and data sources. View complete schedule.
“The term ‘decentralized clinical trials’ (DCTs) has been overused,” according to Burrow. “The fact is that virtually every clinical trial includes some decentralized elements. We’re seeing a spectrum of study designs, operational approaches, and data sources. The challenge remains that true innovation carries its own set of challenges, and we need to do everything we can to minimize patients’ exposure to both seen and unseen risks in this regulated environment.”
“The path ahead requires us all to work together to balance the critical interests involved in supporting innovation in clinical research with the FDA’s role as a global regulatory and enforcement agency focused on protecting public health,” concludes Burrow.
Edited by Jill Dawson