The U.S. Food and Drug Administration (FDA) is highly supportive of clinical trial innovation, including advancing study design, conduct, and reporting within the global ecosystem. In recent years, there have been significant changes across trial design, operational approaches, data sources, numbers of regulatory partners involved, technological sophistication, and the underlying infrastructure of medical practice.
“Change management is an overarching theme in innovation, with a need to mitigate and resolve barriers to change due to low institutional and personal risk tolerance,” says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, at the FDA Center for Drug Evaluation and Research (CDER). “A key question is what kind of behavior changes can help us improve as clinical research professionals? What can we do to advance our subject matter expertise, and our own personal contentment – both at work, and in life. To succeed, we must overcome our fears. This is true no matter what role we’re in or where we’re based.”
“Open conversations on challenging topics are needed to lower anxiety levels about the potential for poor outcomes as a result of change,” states Burrow. “Gatherings like ACRP 2025 provide an opportunity for robust discussion about subjects we typically don’t talk about, helping address fears and identify support systems necessary to drive innovation.”
A mindset shift is needed, notes Burrow, with collaborative approaches to drive innovation globally. One effort is FDA’s CDER Center for Clinical Trial Innovation (C3TI), which acts as a central hub to support innovative approaches to increase the efficiency of drug development. C3TI aims to spur future clinical trial innovation through enhanced communication and collaboration with study stakeholders. The center aims to help clinical researchers stay current with innovations, collaborate with the agency to maximize the potential utility of new innovative tools, and improve the efficiency and effectiveness of clinical trials, including participation of diverse populations. The overarching goal is to accelerate development of safe and effective new drugs.
FEAR: Face Everything and Rise (in Clinical Research)
Join David at ACRP 2025 [April 24-27; New Orleans, La.], as he explores operational strategies for implementing Quality by Design and the integration of Risk Based Quality Management Systems into routine trial design and conduct. View complete schedule.
“Stakeholder engagement with FDA through C3TI offers an opportunity to minimize the potential risks involved in changes,” says Burrow. “Another factor is FDA’s plan to carry out directed inspections, narrowly focused inspections looking only at those aspects of clinical trial conduct and reporting requirements that are essential in the context of a particular marketing application. These types of inspections will not focus on administrative elements which may not be critical to human subject safety or data reliability.”
“If we avoid the things we are scared of, they will continue to be a problem,” concludes Burrow. “We can all work to manage our fears, to ‘face everything and rise.’ Working together, we can cocreate solutions to reimagine clinical research and overcome barriers to innovation.”
Edited by Jill Dawson
