Federal and industry sponsors play complementary roles in cancer clinical trials

A comparative study of the cancer clinical trial portfolios supported by federal funding versus industry funding reveals they have distinct, interdependent roles in cancer research.

The work, "Federal and Industry Sponsorship in US Cancer Clinical Trials," is published online August 20^thby JAMA Oncology.

The analysis found that, whereas industry trials were more likely to examine single-agent treatments, federally supported trials were more likely to focus on non-treatment interventions, diagnostics, health services research, cancer prevention, screening, or supportive care.

Federally funded trials were also more likely to study multimodality treatment regimens or treatment de-escalation strategies, or to address the needs of patients with rare or pediatric cancers.

Further, federally sponsored trials were more commonly phase II trials, whereas industry trials were more often very early phase I trials or later stage phase III trials. 

The authors say their findings are consistent with a model in which federal and industry funders contribute complementary and essential functions to the cancer research ecosystem.

Federally sponsored research brings much of the basic science discovery, trial infrastructure and early efficacy studies, while industry leads in late-stage determinative trials resulting in regulatory approvals. Federally sponsored trials may then test combinations of newly approved drugs with each other or with different treatment approaches such as surgery or radiation, extending therapeutic discovery." 

Joseph M. Unger, PhD, lead author, biostatistician and health services researcher with SWOG Cancer Research Network and professor, Public Health Sciences Division, Fred Hutch Cancer Center

Unger led a team that analyzed data from thousands of cancer trials registered in the ClinicalTrials.gov database from 2008 through 2024. The team identified interventional studies that had opened at one or more U.S. sites. 

Trials were classified as federally sponsored if their lead sponsor was a federal agency, such as the National Institutes of Health. Trials with a pharmaceutical or biotech company as lead sponsor were coded as industry trials.

Among 11,681 trials that met the researchers' criteria, 9,569 (81.9 percent) were industry sponsored. Overall, about 90 percent of all trials had cancer treatment as their primary purpose. 

Among the most marked differences between the two trial portfolios, federally supported trials were much more likely than industry trials to investigate

• dose de-escalation approaches, which ask whether a drug or other intervention can be taken less frequently, for less time, or at a lower dose without compromising patient outcomes; 
• regimens combining multiple modes of treatment – drug treatment followed by surgery followed by radiation therapy, for example;
• non-drug interventions, such as surgery, transplant, or behavioral interventions.

Federal trials were also considerably more likely than industry trials to study childhood cancers or rare cancers (cancers with fewer than 40,000 U.S. diagnoses per year), although the distance between federal and industry sponsors on rare cancer trials has shrunk over the time period studied.

Although they serve a unique and vital role, federally sponsored trials represent a much smaller share of the overall U.S. trial portfolio than industry-sponsored trials; compared to federally supported trials, about 9 out of 10 participants enroll in industry-sponsored trials. 

Given the increasing dominance of industry in cancer clinical research and its core interest in conducting single-agent drug trials, the authors express concern that many research questions important for improving patient care but not commercially attractive may go unanswered.

The work was supported by the Public Health Sciences Division of Fred Hutch Cancer Center and The Hope Foundation for Cancer Research.

In addition to Dr. Unger, contributors to the work include Hong Xiao, PhD, and Michael L. LeBlanc, Ph.D. – both at the SWOG Statistics and Data Management Center and the Fred Hutch Cancer Center – and Dawn L. Hershman, MD, MS, of Columbia University Irving Medical Center.