Federal sponsors and companies ask different questions in oncology trials

Federal sponsors and companies ask different questions in oncology trials

An article in JAMA Oncology, published on August 20, compared 11 681 oncology clinical trials with sites in the United States that began between 2008–2024. Federal agencies served as the lead sponsor for 2 112 trials, while companies served as the lead sponsor for 9 569. The lead sponsor initiates the study and assumes responsibility for it.

A clinical trial begins with a question about what to test: a new drug, a combination of treatments, a preventive intervention, or a way to reduce the burden of treatment. This choice determines how clinicians, patients, and hospitals will spend years of work. The authors found that federal agencies and companies prioritize these questions differently.

Among trials of cancer treatment, a single drug was studied in 77,4% of company-led trials and 48,6% of federally sponsored trials. A drug or biologic combined with radiation therapy was studied in 10,5% of federal treatment trials and 1,4% of industry-led trials. These studies test how several treatments work together.

De-escalation trials test a lower dose or a shorter course of treatment. They accounted for 3,1% of federally sponsored trials and 0,4% of company-sponsored trials.

Prevention accounted for 4,7% of federally sponsored trials and 1,1% of company-sponsored trials. Supportive care, which treats symptoms and the effects of primary therapy, accounted for 2,5% and 0,9%, respectively. The absolute numbers of prevention trials were nearly identical: 99 with federal sponsors and 105 with company sponsors. The percentages describe the composition of two groups whose total numbers of trials differ substantially.

The ratio of industry to federal lead sponsors increased from 2,72 in 2008–2012 to 6,44 in 2019–2024. The government agency ARPA-H is funding the VITAL-H trial, which will test a combination of three already approved drug classes and measures of physical function in healthy people aged 60–65 years.