Study reveals rising pharmaceutical industry sponsored clinical trials in the U.S.

Researchers at Fred Hutch Cancer Center identified a substantial increase over the past decade in the proportion of patients with cancer in the U.S. who participate in pharmaceutical industry sponsored clinical trials compared to those conducted with federal government support. Published in The Journal of Clinical Oncology and presented at the ASCO Quality Care Symposium, these findings reveal trends of underinvestment in federally funded studies, flat enrollment counts in federally funded studies over more than a decade and a growing reliance on industry to conduct cancer research.

The study showed that between 2018 and 2022, industry sponsored trials enrolled over eight times more patients than federally sponsored trials. For adult trials, industry enrolled nearly 10 times more patients. These ratios have also grown substantially over time. Compared to a decade earlier (2008-2012), the proportion of enrollments attributable to industry vs. federal support increased from 4.8 to 9.6 in adults, and from 0.7 to 2.3 in children. The study was conducted in more than 26,000 cancer clinical studies in adults and children using data from clinicaltrials.gov.

The magnitude of difference revealed by the study, which was the first to comprehensively evaluate the comparative roles of industry and federal sponsors in supporting patient enrollments to cancer studies, took the researchers by surprise.

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."

Joseph Unger, PhD, MS, a health services researcher and biostatistician at Fred Hutch and lead author of the study

Federally funded cancer research studies play a critical role due to their demographic diversity. For example, three times more Black participants were enrolled in federally supported research than in industry funded research. In addition to investigating cancer treatments, federally funded research covers a broad set of clinical research questions, such as combining treatment modalities or examining whether approved drugs work in other cancers. Industry funded cancer research predominately aims to support new drug approvals.

"Underinvestment in federally funded cancer clinical research results in missed opportunities for scientific, clinical and populations advances," said Unger. "Federally funded cancer clinical trials have contributed to more than 14 million life years gained over four decades and have helped improve clinical care guidelines for patients."

Despite the need for more federally funded cancer clinical research trials, researchers are quick to point out the importance of both federally funded and industry funded cancer clinical trials.

"Industry investment in cancer clinical research has accelerated precision oncology and cancer immunotherapy tremendously," commented Unger, noting the important role of industry in new drug discovery. "However, with increased federal investment in cancer research as well, we could see even greater strides in treatment options for patients with cancer."

The study was funded by Fred Hutch. Unger reports the following disclosures: serves as a consultant for the American Cancer Society, AstraZeneca and Loxo Oncology/ Eli Lilly Company, which is unrelated to the current work.