Many current trends in clinical research will likely continue regardless of the upcoming changes in the White House. The need to incorporate technology into our clinical trials processes, alongside a continued emphasis on the power of artificial intelligence (AI), will remain a priority for both the U.S. Food and Drug Administration (FDA) and the rest of government in 2025. For example, FDA has repeatedly emphasized a need to move away from paper-based data collection in favor of remote access and more streamlined study processes—all aimed at the larger goal of making trials faster and more cost-efficient.
“Diversity, equity, and inclusion (DEI) may be broadly de-emphasized by the new administration, but the science-based FDA requirement for intentional study recruitment is unlikely to change,” notes Sophia McLeod, Advocacy Advisor, Association of Clinical Research Organizations (ACRO). “The next-generation 21st Century Cures bill will also be a focus in the near future, with an opportunity for stakeholders to advocate for expanded provisions to support the clinical trial ecosystem. This is a rare chance to use our collective voice to elevate our priorities on the Hill as part of an effort to remove more barriers to delivery of new drugs to patients.”
“While we can expect some changes in priorities in 2025, FDA guidances issued thus far, such as the final guidance on decentralized clinical trials, will remain in place,” says Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer for Florence Healthcare. Appropriate technology and remote data capture are already widely supported in FDA guidances to facilitate less costly trials, and this pressure to achieve efficiencies will likely increase with the new administration, she adds.
“The drive to incorporate trials into routine care will also stand, along with intentional FDA language about the responsibilities of the principal investigator and sponsor,” states Gregor. “There is still a need for a new model for trials involving technology vendors that specifies the role of these companies.”
Changes to the Centers for Medicare and Medicaid Services may have a significant impact on clinical trials. “A move toward Medicare Advantage, which is typically less willing to reimburse routine care than Medicare, could negatively impact our ability to treat patients within a trial,” notes Gregor. “This may be particularly problematic in rare disease studies. Another issue is cross-state licensure, which is central to the continued growth of decentralized clinical trials.”
Keeping Up with the FDA’s Changing Ways
Join Catherine and Sophia at ACRP 2025 [April 24-27; New Orleans, La.], where they will will run through the latest guidance changes and what they mean for sites and sponsors in 2025. View complete schedule.
“Sites should get ready for increased technology use, including digitizing data, to achieve economies of scale and inspection readiness,” states McLeod. “At present, only around 10% of the global site market uses digital technology to record data; the remainder uses a combination of paper and SharePoint, or 100% paper records. This is a high-priority area for attention.”
“Regardless of what party is in power, we should lean into the topics we’ve been discussing over the past few years,” concludes Gregor. “These include the need for intentionality around inclusion in clinical trials and the use of technology to gain efficiencies. Finally, we still need to take research into the community, which in turn requires technological innovation, intentional protocol design including diversity planning, and the ongoing efforts of experienced clinical trial professionals.”
Edited by Jill Dawson
