Understanding and accurately naming anatomy, such as using “vulva” instead of “vagina,” is only one part of a broader issue. Equally important is addressing the pervasive misuse of the term “sex,” which is often conflated with penetrative intercourse in clinical research and discussions.
For sponsors and contract research organizations (CROs), trial complexity is increasing due to novel protocol requirements and greater demands on data volume and variety, among other factors. Meanwhile, the research and development product pipeline doubled from 2013 to 2023. Sponsors are increasingly leaning on CRO expertise for newer therapeutic areas, technology infrastructure, evolving regulatory expertise, change management, and more.
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.