Investigators have identified a substantial increase in the proportion of U.S. patients with cancer participating in clinical trials sponsored by the pharmaceutical industry over the past decade compared with those supported by the federal government, according to findings recently presented by Unger et al at the 2024 ASCO Quality Care Symposium (Abstract 46) and simultaneously published in the Journal of Clinical Oncology. The findings highlighted the need for increased investment in federally funded cancer clinical trials.
“Underinvestment in federally funded cancer clinical research results in missed opportunities for scientific, clinical, and populations advances. Federally funded cancer clinical trials have contributed to more than 14 million life-years gained over 4 decades and have helped improve clinical care guidelines for patients,” stressed lead study author Joseph Unger, PhD, MS, a health services researcher and biostatistician at Fred Hutch Cancer Center.
Study Methods and Results
In this study, the investigators examined ClinicalTrials.gov data from more than 26,000 cancer clinical trials involving pediatric and adult patients. They sought to comprehensively evaluate the comparative roles of industry and federal sponsors in supporting patient enrollment to cancer clinical trials.
The investigators determined that between 2018 and 2022, industry-sponsored trials enrolled more than eight times more patients than did federally sponsored trials. For adult trials, industry-sponsored trials enrolled nearly 10 times more patients. The ratios increased substantially over time. Compared with a decade earlier (2008–2012), the proportion of enrollments attributable to industry vs federal support increased from 4.8 to 9.6 in adult patients and from 0.7 to 2.3 in pediatric patients.
Because of their demographic diversity, federally funded cancer research studies often play a critical role. For instance, three times more Black participants were enrolled in federally supported research compared with industry-funded research. In addition to evaluating cancer treatments, federally funded research covers a broad set of clinical research questions—including combining treatment modalities and examining whether approved drugs may work in other cancer types. Industry-funded cancer research predominantly aims to support new drug approvals.
Conclusions
The findings revealed trends of underinvestment in federally funded studies, flat enrollment counts in federally funded studies over more than a decade, and a growing reliance on the pharmaceutical industry to conduct cancer research. Despite the need for more federally funded cancer clinical trials, the investigators indicated the significance of both federally funded and industry-funded cancer clinical trials. For example, industry-sponsored trials may play a critical role in new drug discovery.
“We recognized that industry was playing an increasing role in cancer clinical research compared to decades ago, but we didn’t realize the difference was this dramatic,” Dr. Unger emphasized. “Industry investment in cancer clinical research has accelerated precision oncology and cancer immunotherapy tremendously. However, with increased federal investment in cancer research as well, we could see even greater strides in treatment options for patients with cancer,” he concluded.
Disclosure: The research in this study was funded by Fred Hutch Cancer Center. For full disclosures of the study authors, visit meetings.asco.org and ascopubs.org.
