With recent federal actions upending business as usual for many stakeholders in the clinical research enterprise, some of its thought leaders pondered the big question of “Where does clinical research go from here?” during Friday’s (April 25) first Signature Series gathering at ACRP 2025 in New Orleans. After the heartfelt session closed with a Big Easy-style second line jazz band sendoff, an expert lineup of educational session presenters held forth on an array of vital topics for members of the industry’s workforce during much of the rest of the morning and afternoon.
Noting that everyone involved in clinical research is in the midst of very challenging times, especially when hearing about elimination of jobs, defunding of research projects, and the like, ACRP Board of Trustees Chair Christina Brennan, MD, MBA, CCRC, FACRP, Senior Vice President for Clinical Research with Northwell Health, reminded attendees that, “When you have teams that are counting on you, you [need to] try to be positive, knowing that patients are counting on us.”
Recognizing that there are “things you can’t control and things you can,” Brennan emphasized that “for all the years we took to get [patients] to this spot [of trust in clinical research], we don’t want” to backslide now.
Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer for Florence Healthcare, explained that she has tried to channel some of her anger over current events into productivity, including through a recent blog, and a Call to Action for Clinical Research Advocates. “We’re going to have to pivot” and stay loud as an industry to keep trends in its activities as positive as possible, she said.
R’Kes Starling, RPh, MBA, CEO/President of Reveles Inc., noted that, “There’s grief and profound concern about what the future holds…but [also] profound optimism about” how the clinical research enterprise can move forward. He encouraged attendees to cultivate an “ability to be adaptable and agile” in the face of adversity,” remembering how the research community demonstrated so much resilience during COVID-19’s worst period. “We’re all in this together,” he added.
Missing his first ACRP conference in about 14 years, but supplementing the panelists’ thoughts via a recorded message, David Burrow, Director of the Office of Scientific Investigations in the Office of Compliance for the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, said he is “trying to see the opportunities in the challenges being faced” by everyone in the profession now. “Please know that my commitment remains as strong [as ever] to each and every one of you,” he added.
“We need to take the time to ask how we’re going to handle today’s challenges and move forward,” said ACRP Executive Director Susan Landis.
As Friday’s conference activities turned to the earliest of the overall event’s nearly 75 educational sessions, presenters like Ben Mooso, MS, CCRP, an IRB Specialist at University of California Berkeley, and Megan Lamberti, Vice President of Clinical and Regulatory Affairs for Nilo Medical Consulting Group, offered best practices and lessons learned about some of the nuts and bolts issues that clinical researchers in a variety of specialties and at a range of experience levels can take back to their workplaces.
Talking about “Demystifying Institutional Review Board [IRB] Structures and Processes,” Mooso said U.S. researchers “all have the same regulations” to follow, but “we have different interpretations about” what some of those regulations mean. He will speak again on Sunday (April 27) on “How the New Single IRB Requirements Will Change Clinical Research.”
In her presentation on “Achieving Compassion and Compliance in the Conduct of Clinical Research,” Lamberti said that compassion should extend to everyone involved in “the web of relationships in a trial.” She offered tips on designing and conducting trials with patient centricity in mind, handling interactions with FDA reviewers and IRBs, recognizing and managing signs of emotional strain in clinical research coordinators, and more.
Reported by Gary Cramer
