Cancer Clinical Research Sees Shift Toward Industry-Sponsored Trials
Recent study compared patient enrollment trends in industry- and federally sponsored oncology trials.
Cancer incidence in the United States is on the rise. According to the American Cancer Society, 2024 marks the first year in which new cancer cases are expected to exceed 2 million. This bleak milestone is largely influenced by a rise in the diagnoses of 6 of the 10 most common cancers—breast, prostate, endometrial, pancreatic, kidney, and melanoma. While the risk of dying from cancer has steadily declined over the years, there is no doubt the rare disease continues to pose a large challenge to the research industry.1
As cancer incidence continues to increase, so does the need for research. In oncology, industry relies on both private and public sponsors for trials. Compared to industry-sponsored trials, federally sponsored trials examine a more diverse set of research questions. Despite this key benefit, trends in patient enrollment across both trial types are unknown. A recent study published in the Journal of Clinical Oncology identified these enrollment counts to uncover which was higher.2
“Industry-sponsored clinical trials are conducted to support new drug approvals from the FDA. By contrast, trials sponsored by the National Cancer Institute (NCI) within the National Institutes of Health (NIH) are conducted by both individual investigators and trial networks,” the study authors wrote. “A defining feature of federally sponsored trials is that they investigate a broad set of clinical research questions that are generally not addressed by industry, such as combining treatment modalities or examining whether approved drugs work in other cancers.”
The authors examined enrollment trends from 2008 to 2022 using ClinicalTrials.gov. After dissecting 26,080 total trials, they found that enrollment counts for federally sponsored studies remained flat over the study period. According to the results, the estimated enrollment ratio from 2018 to 2022 for all industry-sponsored versus federally sponsored trials was 8.1. For adult trials, the ratio increased from 4.8 during 2008-2012 to 9.6 during 2018-2022; for trials in children, the ratio increased from 0.7 to 2.3.
“These results demonstrate an increasing reliance in the United States on industry to conduct cancer clinical research. This highlights, on the one hand, increased investment on the part of industry sponsors in the discovery process…However, it also points to the comparative underinvestment in federally sponsored cancer research,” the authors wrote of the findings.
In addition to identifying enrollment counts, the authors found a substantial increase in the ratio of industry to NIH new trial activations from 2018 to 2022. For trials in adults, the 5-year average tripled from 3.2 initially to 9.1. For trials in children, an increase from 1.1 to 3.9 over the study period was observed. Looking forward, the authors anticipate trends like these to continue, with industry-sponsored trials seeing a greater share of patient enrollment in the coming years.
“These different models for cancer clinical research both serve vital functions in new treatment discovery and are, ultimately, complementary,” the authors concluded. “Nonetheless, an underinvestment to the main avenues for federally supported clinical research is occurring at a time when such research is greatly needed to perform the trials that industry will not do. Thus, policymakers should aim to address the increasing imbalance between industry and federally funded cancer clinical research to benefit both researchers and patients in terms of scientific, clinical, and population advances.”
References
1. Collins, S. (2024, January 17). 2024 cancer facts & figures cancer: 2024--first year the US expects more than 2m new cases of cancer. 2024 Cancer Facts & Figures Cancer | 2024--First Year the US Expects More than 2M New Cases of Cancer | American Cancer Society. https://www.cancer.org/research/acs-research-news/facts-and-figures-2024.html
2. Joseph M. Unger et al., Patient Enrollment to Industry-Sponsored Versus Federally Sponsored Cancer Clinical Trials. JCO 0, JCO.24.00843. DOI:10.1200/JCO.24.00843
