Factors Associated With Age Disparities Among Cancer Clinical Trial Participants.

Abstract

Importance\nSeminal investigation 2 decades ago alerted the oncology community to age disparities in participation in cooperative group trials; less is known about whether these disparities persist in industry-funded research.\n\n\nObjective\nTo characterize the age disparities among trial enrollees on randomized clinical trials (RCTs) of common cancers in clinical oncology and identify factors associated with wider age imbalances.\n\n\nData Sources\nPhase 3 clinical oncology RCTs were identified through ClinicalTrials.gov.\n\n\nStudy Selection\nMultiarm RCTs assessing a therapeutic intervention for patients with breast, prostate, colorectal, or lung cancer (the 4 most common cancer disease sites) were included.\n\n\nData Extraction and Synthesis\nTrial data were extracted from ClinicalTrials.gov. Trial screening and parameter identification were independently performed by 2 individuals. Data were analyzed in 2018.\n\n\nMain Outcomes and Measures\nThe difference in median age (DMA) between the trial participant median age and the population-based disease-site-specific median age was determined for each trial.\n\n\nResults\nThree hundred two trials met inclusion criteria. Thr trails collectively enrolled 262\u202f354 participants; 249 trials (82.5%) were industry-funded. For all trials, the trial median age of trial participants was a mean of 6.49 years younger than the population median age (95% CI, -7.17 to -5.81 years; P\u2009<\u2009.001). Age disparities were heightened among industry-funded trials compared with non-industry-funded trials (mean DMA, -6.84 vs -4.72 years; P\u2009=\u2009.002). Enrollment criteria restrictions based on performance status or age cutoffs were associated with age disparities; however, industry-funded trials were not more likely to use these enrollment restrictions than non-industry-funded trials. Age disparities were also larger among trials that evaluated a targeted systemic therapy and among lung cancer trials. Linear regression modeling revealed a widening gap between trial and population median ages over time at a rate of -0.19 years annually (95% CI, -0.37 to -0.01 years; P\u2009=\u2009.04).\n\n\nConclusions and Relevance\nAge disparities between trial participants and the incident disease population are pervasive across trials and appear to be increasing over time. Industry sponsorship of trials is associated with heightened age imbalances among trial participants. With an increasing role of industry funding among cancer trials, efforts to understand and address age disparities are necessary to ensure generalizability of trial results as well as equity in trial access.