'Stark' finding: Cancer research in US increasingly dominated by industry sponsors
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Key takeaways:
- Enrollment in industry-sponsored trials substantially outpaced that of federally sponsored trials during the past decade.
- It is critical to educate stakeholders on the importance of federal trials.
Industry-sponsored clinical trials have enrolled significantly more participants than federally sponsored trials over the past decade, according to retrospective study results.
The pharmaceutical industry has done “great work” developing new drugs and therapeutics, but federally sponsored trials tend to be more “patient friendly” and investigate issues that industry-sponsored trials do not, Joseph M. Unger, PhD, MS, associate professor at Fred Hutch Cancer Center, told Healio.
With that context, the latest findings are “stark,” Unger said.
“Federally sponsored, cancer clinical research has a unique role in identifying treatments that are best for patients,” Unger added. “It’s not a role that can be supplanted by industry. It’s a role that is its own, and I think that can be easily forgotten.”
Different trial models
Clinical trial enrollment has more than doubled over the past 30 years. More than 20% of patients with cancer participate in some form of research, Healio previously reported.
“This is set against a backdrop where cancer incidence continues to increase,” Unger said. “It’s gone up 20% in the last decade. One would hope that research is keeping pace of that.”
Industry- and federally sponsored trial objectives can be much different, though.
The pharmaceutical industry focuses on getting approvals for new drugs, while federal trials examine a broad range of issues, including combination therapies, mixed modalities, de-escalation and supportive care.
“Industry doesn’t have as much motivation to do those kinds of trials,” Unger said. “Industry isn’t particularly motivated to conduct de-escalation trials, as it would mean giving less of a drug. They typically will not be interested in combining drugs with different modalities of treatment — for instance, radiation therapy. They’re primarily focused on getting that new drug approval. The model of federally sponsored trials is not based on profit. It’s based on the scientific question at hand: What’s the best outcome for patients?”
Methods and results
Unger and colleagues used ClinicalTrials.gov to investigate participation trends for industry- and federally sponsored trials.
They examined 26,080 studies conducted between 2008 and 2022 (82.7% treatment trials; 70.7% drug/biological agent trials; 31.7% industry; 4.9% federal).
Enrollment for industry- and federally sponsored trials served as the primary endpoint.
For industry-sponsored clinical trials, adult participation increased from 54,127 between 2008 and 2012 to 113,527 between 2018 and 2022. Child participation increased from 3,284 to 6,428 over the same period.
For federally sponsored trials, adult participation increased from 11,282 between 2008 and 2012 to 15,739 between 2013 and 2017, then declined to 11,798 between 2018 and 2022. Child participation decreased from 3,651 between 2008 to 2012 to 2,828 between 2018 and 2022.
Industry-sponsored trials had an overall estimated participation ratio 8.1 times higher (interquartile range, 6.2-9.9) than federally sponsored trials between 2018 and 2022.
Accounting just for adults, the ratio increased from 4.8 (interquartile range, 4.4-5.3) between 2008 and 2012 to 9.6 (interquartile range, 7.4-11.8) between 2018 and 2022.
For children, the ratio rose from 0.7 (interquartile range, 0.6-0.7) between 2008 and 2012 to 2.3 (interquartile range, 1.8-2.7) between 2018 and2022.
‘Proactive steps’ needed
Unger and colleagues also found the 5-year average ratio of industry-sponsored trials vs. federally sponsored trials between 2018 and 2022 increased substantially for both adults (3.2 to 9.1) and children (1.1 to 3.9).
“There wouldn’t be a problem if industry were doing a lot of trials, enrolling patients and making new discoveries, and federally sponsored trials were keeping pace ... but that’s not the case,” Unger said.
“The importance of federally sponsored trials extends beyond the types of trials conducted,” Unger added. “They tend to be more diverse, as well.”
In 2019, Jonathan Loree, MD, MS, FRCPC, medical oncologist at BC Cancer and associate professor at The University of British Columbia, and colleagues showed several populations were underrepresented in landmark trials that led to FDA oncology drug approvals.
Their analysis included 232 trials conducted between 2008 and 2018 that led to 204 drug approvals during that decade.
Relative to their proportion of cancer incidence in the U.S. at that time, Black individuals (22% of expected enrollment) and Hispanic individuals (44% of expected enrollment) were underrepresented compared with white individuals (98% of expected enrollment) and Asian individuals (438% of expected enrollment).
“My colleagues and I collaborated with Dr. Loree to do a matched analysis where, within the same cancers over the same time period, we compared representation data from the SWOG Cancer Research Network to representation in the industry trials,” Unger said. “We found that when you make that apples-to-apples comparison, representation in SWOG treatment trials was 9% Black individuals as opposed to still 3% Black individuals in industry trials.”
The “fear” is that policymakers and stakeholders will see overall increased participation among trials as positive news and not invest in federally sponsored programs, Unger said.
“Industry is only looking at one half of the research spectrum — the new drug identifications,” Unger said. “They’re not looking at how to use those new drugs in various ways in the same way that federally sponsored clinical researchers do.”
More money is needed to close the gap, Unger added.
“It’s not an unlimited supply of patients who are willing to go on to trials,” he said, estimating the ratio between 6% to 8%. “To some degree, sponsors are competing for those patients to participate in their studies. That ratio can’t just expand indefinitely. There is a constraint in the system.”
In an accompanying editorial, Yara Abdou, MD, assistant professor of medicine at UNC School of Medicine, and Norman E. “Ned” Sharpless, MD, professor of cancer policy and innovation at UNC School of Medicine, detailed four strategies for addressing the issue: educating stakeholders, diversifying funding source, institutional support from academic centers and engaging foundations.
“By taking proactive steps, the research community can safeguard the future of cancer clinical trials, driving continued scientific innovation and ensuring that the benefits of research advancements are accessible to all patient populations,” Abdou and colleagues wrote.
References:
- Abdou Y, et al. J Clin Oncol. 2024;doi:10.1200/JCO-24-01484.
- Unger JM, et al. J Clin Oncol. 2024;doi:10.1200/JCO.24.00843.
For more information:
Joseph M. Unger, PhD, MS, can be reached at junger@fredhutch.org.
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