Federal and Industry Sponsors Play Complementary Roles in US Cancer Clinical Trials, With Drug Costs Reaching Millions

A comparative analysis of the cancer (搜索)搜索该疾病 clinical trial portfolios supported by federal versus industry funding reveals that the two sponsors serve distinct, interdependent roles in the US cancer research ecosystem. The study, "Federal and Industry Sponsorship in US Cancer Clinical Trials," published online August 20th by JAMA Oncology, found that industry trials were more likely to examine single-agent treatments, while federally supported trials more often focused on non-treatment interventions, diagnostics, health services research, cancer prevention, screening, or supportive care.

The work was led by Joseph M. Unger (搜索)搜索该词条, PhD, a biostatistician and health services researcher with the SWOG Cancer Research Network查看公司主页 and professor in the Public Health Sciences Division at Fred Hutch Cancer Center (搜索)搜索该词条. Unger and colleagues analyzed data from thousands of cancer (搜索)搜索该疾病 trials registered in the ClinicalTrials.gov database from 2008 through 2024, identifying interventional studies that had opened at one or more US sites. Trials were classified as federally sponsored if their lead sponsor was a federal agency such as the National Institutes of Health查看公司主页, while trials with a pharmaceutical or biotech company as lead sponsor were coded as industry trials.

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

Distinct Trial Portfolios

The analysis identified several marked differences between the two 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. Federal trials also more frequently studied regimens combining multiple modes of treatment—for example, drug treatment followed by surgery followed by radiation therapy—as well as 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, defined as cancers with fewer than 40,000 US diagnoses per year, although the gap between federal and industry sponsors on rare cancer (搜索)搜索该疾病 trials has narrowed over the study period.

In terms of trial phase, 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.

"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," Unger said. "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."

The Financial Burden of Federally Sponsored Trials

A separate evaluation led by Unger and colleagues quantified the drug acquisition costs of federally sponsored cancer (搜索)搜索该疾病 trials, underscoring a significant financial barrier to this research. The analysis of 1,378 trials initiated between 2017 and 2023—comprising 32.7% phase 1, 60.5% phase 2, and 6.8% phase 3 studies and including 140,066 patients—found a median planned drug cost of $7.58 million per trial.

Trials solely supported by federal funds accounted for 29.1% of the cohort, while trials in which federal sponsorship played a secondary or tertiary role comprised 67.8%. Trials led by federally sponsored researchers alone had significantly higher drug costs (median, $11.08 million) than those for which federal sponsorship was secondary or tertiary (median, $6.05 million; P < .001).

Phase 3 trials, which are generally much larger, had significantly higher median drug costs ($58.92 million) than phase 1 ($4.84 million) and phase 2 ($8.12 million) trials (P < .001). Median drug costs for trials investigating immunotherapies ($9.25 million) and targeted therapies ($6.6 million) far exceeded those involving chemotherapy ($0.43 million). Experimental agents accounted for approximately 80% of all drug costs, with a median of $5.56 million.

Each patient had a median drug cost of $163,234, with significantly higher costs in trials involving immunotherapies or targeted agents ($198,431) than chemotherapies ($9,332; P < .001). Among 221 phase 2 or 3 comparative trials, experimental agents had significantly higher median costs ($12.91 million) than control therapies ($2.05 million).

"The findings really do underscore the significant financial burden of trial conduct in terms of the supply and provision of drugs, and the need for policy innovations to reduce costs and hopefully better support clinically relevant, federally funded research," Unger told Healio.

Unanswered Questions and Policy Implications

Drug companies account for about nine times more patient enrollments than federally sponsored trials. While industry sponsorship is critical for seeking new drug approvals and indications, it often leaves many clinically important questions unanswered—including whether a drug can be combined with other therapies, whether it can be used for rarer malignancies, and whether the dose can be lowered.

"Drug companies are not interested in every research question that federally sponsored researchers want to ask," Unger said.

Federal funding for NCI research project grants declined from $3.15 billion in 2023 to $3.12 billion in 2025. This funding typically pays for infrastructure and operational costs but not the drugs themselves, leaving researchers to negotiate for their use—a process that can take months or even up to a year.

"For federally sponsored researchers, the reliance on industry sponsors for drug supply can end up limiting the types of questions that can be asked, especially if industry conditions their participation on a fixed schedule and dose," Unger explained.

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

"The drug costs were very high," Unger said. "The sheer cost of innovation and discovery ends up accelerating the inflationary costs in medicine for patients with cancer (搜索)搜索该疾病."

Unger emphasized the complementary nature of the two funding sources, noting that federal and industry sponsored researchers need each other. "One study a few years ago showed that among 300 or so molecules that led to FDA drug indications, all of them included federal sponsorship in early discovery," he said. "An ASCO study showed that a very large proportion of industry trials are conducted at NCI-designated cancer (搜索)搜索该疾病 centers. Over decades, NCI funding has created the infrastructure for the conduct of industry sponsored trials."

Yet Unger argued that industry has derived most of the benefit. "The U.S. system is a great engine of discovery among all the countries in the world, yet an outsized portion of the benefits have gone to industry, even as federal support for the conduct of trials has not even kept up with cancer (搜索)搜索该疾病 incidence," he said. "A more balanced system would better reflect all the research and discovery that's been done by federally sponsored researchers."

"Federally sponsored researchers serve a vital role. Given budgetary constraints, federally sponsored groups can't do the number of trials to answer all the questions that are out there. More funding means more discovery. That's a simple equation," Unger concluded.

The JAMA Oncology study was supported by the Public Health Sciences Division of Fred Hutch Cancer Center (搜索)搜索该词条 and The Hope Foundation for Cancer (搜索)搜索该疾病 Research. In addition to Dr. Unger, contributors include Hong Xiao, PhD, and Michael L. LeBlanc, PhD, 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. Researchers acknowledged study limitations, including the variability of drug prices.