With industry’s role in US cancer clinical trials expanding dramatically in recent decades, a new study raises concerns that drug makers’ focus on single-agent therapies could leave many important questions unanswered.

The analysis, of nearly 12,000 cancer trials conducted between 2008 and 2024, found that industry-sponsored studies overwhelmingly tested single therapeutic agents. In contrast, federally funded research often took a broader view — looking at multimodal therapies, safer dosing and treatment deescalation, supportive care, and patients with rare tumor types.

Researchers said that while those two approaches are necessary and “complementary,” the sheer number of trials backed by industry raises important issues.

Those studies currently account for over 90% of adult patient enrollments, meaning certain research targets may be “squeezed out” in the competitive clinical trials environment.

“If it’s increasingly dominated by industry, it ends up being the case that there’s just going to be less opportunity to ask these kinds of non-drug-specific questions that federally sponsored researchers specialize in,” said Joseph Unger, PhD, a health services researcher with the SWOG Cancer Research Network and professor at Fred Hutch Cancer Center, Seattle.

He and his colleagues reported their findings in JAMA Oncology.

A Role Reversal

As Unger told Medscape Medical News, the prime sources of funding for US cancer clinical trials have flipped since the 1990s, when federal support was largely the “only game in town.”

Since then, industry’s role has expanded so dramatically that it now dominates. In prior work, Unger’s team found that by 2012, adult patient enrollment in industry-sponsored cancer trials was outpacing that of federally funded trials by almost 5-to-1. By 2022, the gap had surpassed 9-to-1.

There has always been a general acknowledgment that industry focuses on new therapeutic agents and regulatory approval, while publicly funded research often addresses the broader picture of cancer care.

But the new study aimed to quantify those differences. Unger’s team found that fewer than half (48.6%) of federally funded efforts were single-agent drug trials compared with 77.4% of trials backed by industry.

A significant share of federal funds instead went to trials asking more complex questions.

Specifically, publicly financed efforts were more likely to focus on prevention (4.7% of federal trials vs 1.1% of industry trials), supportive care (2.5% vs 0.9%), multimodal regimens of drugs plus biologic agents (19.1% vs 7.4%) or drugs plus radiotherapy (10.5% vs 1.4%), and treatment deescalation (3.1% vs 0.4%).

Research into rare cancers (defined as an annual US incidence below 40,000) was also more likely to receive federal dollars. Among federal trials, 17.5% were focused on those tumor types vs 12.1% of industry-funded trials, while 16% vs 5% involved pediatric cancers.

Toward a ‘Healthier Ecosystem’

According to senior author Dawn Hershman, MD, the findings illustrate the fact that the US has “a terrific system funded by government to conduct trials that impact care.”

“It complements industry, and we all need to work collaboratively, and quickly, to reduce the burden of cancer,” said Hershman, deputy director of the Herbert Irving Comprehensive Cancer Center at Columbia University in New York City.

In sheer numbers, though, commercially funded trials eclipse those backed by government: 9569 (82%) vs 2112 (18%) in this study.

According to Unger, as industry share of cancer clinical trials has ballooned over time, the federal government’s share has flatlined. The result is a clinical trials ecosystem that he called “out of whack.”

To investigate the full range of questions important to cancer care “you need this healthy ecosystem,” Unger said, and “that means that both partners have to be healthy.”

He said it’s tough to foresee industry switching away from single-agent, profit-driven considerations. Unger noted, for example, that federal legislation was needed to persuade industry sponsors to include children in cancer clinical trials for drugs that might someday have pediatric use.

The prospect for change, he said, probably lies in the public sphere.

In the meantime, industry and government compete for the same finite pool of potential trial enrollees. According to Unger, patients with cancer are often highly motivated to be involved — if suitable trials exist. But groups like SWOG, he said, now receive levels of federal funding that are failing to keep pace with inflation, raising tough questions for researchers.

“How do we find nonfederal dollars to do what we do? Or how do we do less of what we want to do and still do it well?” Unger said. “That’s the problem from my perspective.”

The study was funded by Fred Hutch and the Hope Foundation for Cancer Research. Hershman had no relevant disclosures; Unger reported consulting fees from Eli Lilly and AstraZeneca for work unrelated to the study.