Clinical trials in 2025 will be beset by rising costs and uncertain regulations while also benefiting from new technologies and expansion of site networks, predicts Velocity Clinical Research CEO and President Paul Evans, Ph.D.
Velocity is a clinical research organization headquartered in Durham, North Carolina, with sites across the U.S. and Europe.
In an email to Fierce Biotech, Evans said he expects rising costs to drive efficiency in the industry. Artificial intelligence, he said, could help address rising R&D costs by reducing administrative costs, helping recruit and retain patients and improving data quality.
Several CROs, such as Charles River and Icon, have conducted layoffs amid revenue dips this year caused in part by declining demand from pharmaceutical clients.
Efficiency gains can also come from site networks, which are becoming increasingly popular, Evans said. He highlighted data from the L.E.K Clinical and eClinical Pharma survey showing that 21% of phase 3 trials used site management organizations in 2023, compared to only 15% in 2021.
Several site networks have grown this year, including Headlands Research, which added a new El Paso, Texas, site, and Parexel’s Site Alliance Vaccine Network, which welcomed the U.K.’s Panthera Biopartners.
Evans also expects obesity trials to continue to proliferate, along with the use of digital tools and AI that have been purposefully built by trial sites for trial sites.
An area where AI has recently proven useful is in matching patients to clinical trials; a National Institutes of Health study found that a large language model could speed up this process by 40% without losing accuracy.
One big question mark for the industry going into 2025 centers around diversity in clinical trials. The FDA’s mandate requiring diversity action plans for trials, to ensure they represent real-world patient demographics, is supposed to be finalized in June 2025.
“However, whether the new administration will support or enforce it is unclear,” Evans said. “The Trump team has yet to comment publicly on the mandate, and there is the possibility that they will delay or stall the project indefinitely.”
Genentech’s Site Alliance, a program designed to increase the participation of underrepresented groups in clinical trials, announced in August that its sites enroll more Black and Hispanic/Latinx patients than other sites in the same studies and enroll these groups about two times faster.
While there are many question marks around the future of clinical trials, the industry is still projected to see growth by 2030, hitting $13.76 billion in global value that year, according to a report from Research and Markets.
Whatever 2025 brings for clinical trials and the CRO industry, the Fierce team will be there to explain it all with clarity and rigor. Happy holidays!