Restrictive eligibility criteria in FDA-approved oncology trials following ASCO Guideline updates.

Abstract

11020 Background: Despite significant advancements in new targeted and immunotherapies, enrollment in oncology clinical trials remains unrepresentative of real-world patient populations. Overly restrictive eligibility criteria – particularly related to Eastern Cooperative Oncology Group (ECOG) performance, cardiovascular status, HIV status, and prior malignancy – have been identified as key barriers to trial participation and generalizability. In response, the American Society of Clinical Oncology (ASCO) published new guidelines in 2017 lowering thresholds for enrollment. We examined whether these ASCO recommendations translated into measurable changes in eligibility criteria among FDA-approved trials for the five most common solid tumors. Methods: Clinical trial data was obtained from ClinicalTrials.gov, FDA Approved Drug Notification Database, and journal manuscripts. The study evaluated clinical trials that led to FDA-approved therapies for NSCLC, breast, melanoma, prostate, and colon cancer between 2006-2025. Eligibility criteria based on Eastern Cooperative Oncology Group (ECOG) performance, cardiovascular status, HIV status, and prior malignancy were extracted. Clinical trials were categorized as pre- or post-ASCO 2017 guideline publication, and t-tests (R v4.3.1) were used to compare exclusion rates between groups and assess alignment with ASCO recommendations. Results: Between 2006-2025, there were 167 FDA-approved clinical trials for NSCLC (59), breast (44), melanoma (25), prostate (23), and colon (16) malignancies. The proportion of trials initiated after the 2017 ASCO guidelines was 19 (32.2%) of NSCLC, 12 (27.3%) of Breast, 6 (37.5%) of Colon, 5 (21.7%) of Prostate, and 5 (20.0%) of Melanoma. There was no statistically significant reduction in the usage of restrictive exclusion criteria when comparing trials started before and after the 2017 ASCO recommendations among Colon (p = 0.953), Prostate (p = 0.896), Melanoma (p = 0.775), NSCLC (p = 0.301), and Breast (p = 0.117) cancer groups regarding ECOG performance, cardiovascular status, HIV status, and prior malignancy. Conclusions: Despite the publication of ASCO’s 2017 eligibility guideline updates, restrictive exclusion criteria remain prevalent in FDA-approved oncology trials across major solid tumors. These findings suggest that guideline dissemination alone has been insufficient to change trial design practices. More proactive regulatory, sponsor-level, and implementation-focused interventions may be required to ensure broader trial access and improve the generalizability of oncology clinical research.