Factors Associated With Age Disparities Among Cancer Clinical Trial Participants

Abstract

IMPORTANCESeminal 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. OBJECTIVE To 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. DATA SOURCES Phase 3 clinical oncology RCTs were identified through ClinicalTrials.gov. STUDY SELECTION Multiarm RCTs assessing a therapeutic intervention for patients with breast, prostate, colorectal, or lung cancer (the 4 most common cancer disease sites) were included. DATA EXTRACTION AND SYNTHESIS Trial data were extracted from ClinicalTrials.gov. Trial screening and parameter identification were independently performed by 2 individuals. Data were analyzed in 2018. MAIN OUTCOMES AND MEASURESThe 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.RESULTS Three hundred two trials met inclusion criteria. The trials collectively enrolled 262 354 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 < .001). Age disparities were heightened among industry-funded trials compared with non-industry-funded trials (mean DMA, −6.84 vs −4.72 years; P = .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 = .04). CONCLUSIONS AND RELEVANCEAge 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.

High microsatellite instability (MSI-H) is associated with distinct clinical and molecular characteristics and an improved survival in early Colon cancer (CC); real world data from the AIO molecular registry Colopredict Plus

“…Consistent with other German registries, the enrolled patients had a higher median age compared to interventional studies, with women being older than men (▶ Table 1) [8,12,28]. In clinical trials, less than 10 % are > 75 years, whereas the demographic percentage of this age group is around 40 % [4,5,29]. Data from patients over 80 years in randomized clinical trials (RCT) are practically not available [30].…”

“…Improvement in screening and treatment over the past decades has decreased the incidence, but interestingly, the UICC stage distribution has not changed [1][2][3]. Especially in the growing age group of patients over 80 years, there is little prospective data on baseline characteristics including co-morbidities, adjuvant treatment, or follow-up, mainly because elderly patients are less frequently included in clinical trials [4,5]. Thus, our German CRC guideline presently does not advise the use of adjuvant chemotherapy in patients over 75 years of age because of lack of evidence from randomized trials.…”

Performance Status Restriction in Phase III Cancer Clinical Trials

“…gov to search for oncologic phase III RCTs as described in previous research. 16 The following advanced search parameters were used: other terms: "cancer"; study type: See page 1431 for related commentary. "all studies"; status: excluded "not yet recruiting"; phase: phase III; study results: "with results."…”

Age no bar: A CIBMTR analysis of elderly patients undergoing autologous hematopoietic cell transplantation for multiple myeloma

“…Older patients often are excluded from clinical trials, 18 particularly transplantation trials, either due to ineligibility or physician decision regardless of eligibility. To the best of our knowledge, there are no randomized data examining AHCT among patients newly diagnosed with MM who are aged ≥70 years.…”