In late October, thought leaders from across the clinical research industry gathered to explore how technology can facilitate connectivity between clinical research sites and sponsors. Research Revolution, powered by Florence Healthcare, an ACRO member company, brought together sites, sponsors, CROs, and clinical technology companies to share insights, strategies, and success stories that are reshaping the industry and driving collaboration.
Robert M. Califf, MD, MACC, former FDA Commissioner and Instructor of Medicine at Duke University, opened the conference in a conversation with ACRO Board member Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare. While this discussion touched on a wide array of topics (e.g., AI, misinformation, and technological change management), Dr. Califf began by reflecting on the progress made in clinical trial operations, both in theory and practice, while noting that increased protocol complexity has slowed trials despite the ever-growing availability of technology. As he pointed out, “we have been unable to achieve an economy of scale.” He acknowledged that the number of players beyond sponsors and sites involved in clinical trials, including participants, regulatory systems, and IRBs, create “a recipe for inefficiency, because it really is almost a social activity as much as it is anything else to reach agreement… How do you get people to work together to achieve common purposes?”
The relationship between healthcare and clinical research became a major focus of the conversation, with Dr. Califf highlighting that research and practice are often treated as separate entities in the U.S. healthcare system. He called for renewed thinking around integrating clinical trials into research to deliver more effective treatments and operational improvements. Along these lines, Dr. Califf also addressed the challenges of balancing financial objectives with professionalism in clinical practice. He emphasized the importance of speaking up to ensure that clinical decisions are based on evidence and patient needs.
“Your fiduciary interest is to the patient, not to the entity that you work for, and that requires that you speak up, because it’s so much easier just to focus on the money and assume that someone else is worrying about what’s good for the patient, and I would really emphasize having the courage to speak up.”
In the spirit of deploying one’s voice to accelerate innovation and better serve patients, Catherine Gregor, Sophia McLeod of ACRO, and former ACRO Board of Directors Chair Jackie Kent (Pictured Left to Right Below), came together in a breakout session to lead a conversation regarding the current state of the clinical research industry, the impact of FDA’s evolving policies, what the future holds, and how we can actively engage in delivering necessary change. Their conversation echoed Dr. Califf’s remarks, emphasizing the need for better integration of research into healthcare, highlighting challenges of site selection and feasibility, and underscoring the importance of balancing profitability with professionalism. They closed the session by stressing the importance of advocacy in combating misinformation and encouraging industry professionals to engage with policymakers.
ACRO members were well represented at Research Revolution, participating in panels and presentations on topics ranging from risk management to representative research to the role of AI in clinical innovation:
Engaging with our members and industry luminaries on this level is an important part of the relationship and partnership development that will strengthen industry growth, drive innovation, and ensure regulatory stability.
