The studies industry neglects: Characteristics of cancer clinical trials conducted by federal versus industry sponsors.

Abstract

11095 Background: A defining feature of federally sponsored cancer clinical trials is their mandate to examine clinical research questions not routinely addressed by industry, which is financially incentivized to conduct trials that support new drug applications to the FDA. Yet no evaluation has quantified the types of trials federal versus industry sponsors conduct. These data are vital for policymakers given the need to prioritize federally sponsored trials in a clinical research landscape increasingly dominated by industry sponsorship. Methods: We analyzed registry data from ClinicalTrials.gov between 2008-2022. U.S.-based interventional trials for patients with cancer were included. Studies were categorized by lead sponsor (federal versus industry) and by purpose, phase, intervention, de-escalation, rare cancer, and age. Odds ratios were calculated. Chi-square tests were used. Results: Overall, N=9,626 federal (n=1498, 15.6%) and industry (n=8128, 84.4%) sponsored studies were examined. Most studies were conducted for treatment (federal, 92.8%; industry, 97.5%). Federally sponsored studies were more commonly prevention (5.3% vs 1.2%, OR=4.69, p<.001), screening (1.0% vs 0.4%, OR=2.73, p=.003), and early phase (91.6% vs 81.6%, OR=1.77, p<.001) studies (Table). Federally sponsored studies were more commonly multi-modality studies combining drug and biologic agents (24.3% vs. 7.4%, OR=3.28, p<.001) or systemic therapy with radiation or surgery. Federally sponsored studies also more commonly tested dose de-escalation strategies (1.5% vs 0.6%, OR=2.68, p<.001) and were more often conducted in rare cancers and in children. Conclusions: Nontreatment interventions, early phase, multi-modality, dose de-escalation, rare cancer, and child-focused studies were much more likely to be conducted by federally sponsored research groups than by industry. These findings highlight the unique role of federally funded studies in cancer clinical research. Federal- versus industry-sponsored study characteristics. Federal Industry Study Characteristic Category N=1498 % N=8128 % Odds ratio (Fed/Ind) P-value Purpose Prevention 74 5.3 89 1.2 4.69 <.001 Screening 14 1.0 28 0.4 2.73 .003 Supportive Care 13 0.9 74 1.0 0.95 1.0 Treatment 1304 92.8 7504 97.5 0.56 <.001 Phase 1 or 2 1288 91.6 6307 81.6 1.77 <.001 3 118 8.4 1424 18.4 0.40 <.001 Intervention Biological (B) 97 8.1 668 8.9 0.77 .39 Drug (D) 654 54.4 6180 82.1 0.24 <.001 D & B 292 24.3 558 7.4 3.28 <.001 D/B & Radiation 120 10.0 104 1.4 6.72 <.001 D/B & Surgery 39 3.2 15 0.2 14.46 <.001 Dose de-escalation Yes 23 1.5 47 0.6 2.68 <.001 Rare cancer 1 Yes 284 19.0 977 12.0 1.71 <.001 Age category Child 2 192 12.8 451 5.5 2.50 <.001 Fed=Federal; Ind=Industry. Percentages and p-values calculated among those in the specified categories. “Other” categories not shown. 1 Cancers that affect <40,000 U.S. persons/year. 2 Studies that include those <18 years.