Community engagement is an important step in increasing diversity in clinical trial enrollment. Engagement involves a conversation with members of the community, with a goal of building trust by being of service in ways most important to that community. This should happen long before any discussion about clinical research or a specific trial, meeting individuals where they are and understanding—and helping address—their needs and concerns.
With a focus on prioritizing patient and investigator needs, the traditional sponsor-contract research organization relationship is evolving to include sites as part of the partnership matrix. This, combined with the increasing adoption of Functional Service Provider delivery models, has made determining the right balance of control and accountability for each party a critical factor in successful outsourcing partnerships.
As Chief Clinical Trial Officer at Florence Healthcare, Catherine Gregor has the privilege of collaborating with research sites, sponsors, and CROs on the frontlines of clinical trial operations. Every day, she witnesses the dedication and innovation required to bring new treatments to patients swiftly and safely. However, the recent announcement of significant workforce reductions at the U.S. Department of Health and Human Services (HHS) poses a substantial threat to this progress.
The workforce cuts at the federal agencies charged with guarding the public’s health are unsettling and worrisome. Our hearts and minds turn to our members and those in the broader clinical research community who are bearing the brunt of layoffs, elimination of research funding, and cancellation of programs that work to improve representation in clinical trial participation. We worry about the patients and families who may be left without hope.
Clinical research is a core component of medical progress, enabling the development of new treatments and therapies that improve patient care. Its success isn’t just about scientific accuracy; it largely depends on including a variety of patient groups in the studies.