To quantify differences in clinical trial participation and determine associated delivery system factors among patients with advanced cancer.
Approach:
Study Design: A retrospective observational cohort analysis using the US Flatiron Health Research Database, examining over 200,000 patients with advanced cancer.
Data Collection: Utilized structured and unstructured deidentified information, including demographics and clinical variables, from over 280 clinical sites.
Eligibility Criteria: Included adults aged 18 years or older diagnosed with one of 14 advanced or metastatic solid malignancies from January 1, 2011, to December 31, 2024.
Outcome Measurement: Clinical trial participation was operationalized as receipt of a clinical study drug, extracted from electronic health records.
Key Findings:
Enrollment in clinical trials for advanced cancer remains below 10% despite patient willingness.
Variation in trial participation is influenced by physician referral practices and practice infrastructure.
The study highlights the need to characterize physician and practice-level contributions to trial enrollment variability.
Interpretation:
The principal bottleneck for clinical trial enrollment resides in the clinical delivery architecture rather than patient-level obstacles.
Limitations:
The study was exempt from Institutional Review Board review, which may limit generalizability.
Data was derived from a single database, potentially introducing selection bias.
Conclusion:
Understanding the variability in trial participation at the physician and practice levels is essential for identifying systemic bottlenecks and improving access to clinical trials.
