Federal and industry sponsors play complementary roles in cancer clinical trials
· News-MedicalA 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 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.
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.
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 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.
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.
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