Industry-sponsored cancer clinical trials often focus on single-agent drug trials, while federally funded cancer clinical trials are more likely to investigate drug combinations with other treatments, including biologics or radiation. An analysis evaluating the quantitative role of federally funded cancer clinical trials vs those funded by industry sponsors found that early-phase, multimodality, dose de-escalation, rare cancer, and child-focused drug and biological agent clinical trials were more likely to be conducted by federally sponsored research groups. The findings highlight the unique role of federally funded studies in cancer clinical trials—and how cuts to federal research funding may hinder progress in cancer outcomes. The study will be presented by Unger et al during the 2025 ASCO Quality Care Symposium, taking place October 10 to 11 in Chicago (Abstract 94).
Study Methodology
The researchers analyzed registry data from ClinicalTrials.gov from 2008 to 2024 to identify U.S.-based trials that included drug or biological agents for the purpose of cancer treatment. Studies were then categorized by lead sponsor; federal vs industry; and study phase, intervention, de-escalation, rare cancer, and age. Odds ratios were calculated, and Chi-square tests were used.
Results
The researchers found that of the 10,142 cancer clinical trials they analyzed, 1,711 (16.9%) were federally funded and 8,431 (83.1%) were industry funded. When comparing federally funded trials to industry-funded studies, the researchers found that:
- Federally funded studies were more commonly early-stage (phase I or II) trials (87.3% vs 82.0%), while industry-funded studies were more commonly phase III trials (18.0% vs 12.7%).
- Federally funded studies were less commonly single-agent drug trials (50.8% vs 79.9%).
- Federally funded studies more commonly involved complex multimodality drug or biological agent combinations alone (20.2% vs 7.7%) or with radiation (11.0% vs 1.5%), surgery (2.6% vs 0.2%), transplantation (1.5% vs 0.1%), or combined modalities (1.9% vs 0.1%).
- Federally funded trials were more often conducted in rare cancers (17.8% vs 12.3%) and pediatric cancers (16.2% vs 5.1%).
- Federally funded trials more commonly focused on dose de-escalation (3.2% vs 0.4%).
“Early-phase, multimodality, dose–de-escalation, rare cancer, and child-focused drug and biological agent cancer clinical trials were more likely to be conducted by federally sponsored research groups. These findings highlight the unique role of federal funded studies in cancer clinical trials. Decreases in federal funding may hinder progress in cancer outcomes,” concluded the study authors.
The Importance of Maintaining Federally Funded Cancer Research
“Federal trials fill critical gaps left by industry, especially in early-phase research, multimodality treatments, rare cancers, and treatments for children,” said Joseph M. Unger, PhD, MS, lead author of this study and Professor, Cancer Prevention Program at Fred Hutchinson Cancer Center. “The trials that address these types of research questions are vital for patients and their families, even if the outcomes of such trials are not profitable for private companies. Sustained or increased funding is essential to maintain progress in these areas and to maintain a healthy cancer research ecosystem that balances federally sponsored and industry-sponsored trials.”
ASCO Perspective
“Federally funded cancer clinical trials play an important role in evaluating interventions and improving cancer outcomes in settings and populations that are not prioritized by industry,” said Julie R. Gralow, MD, FACP, FASCO, ASCO Chief Medical Officer and Executive Vice President. “With more than 18 million cancer survivors in the United States, federal research has delivered an undeniable return on investment. To ensure healthier futures, we must continue to invest in the research that advances prevention, detection, and treatment.”
Disclosures: Funding for this study was provided by The Hope Foundation. For full disclosures of the study authors, visit coi.asco.org.
