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Pooling 13 studies of 8,883 patients, 56% had no trial available at their site and a further 22% were ineligible for the trials that existed; among patients actually offered a trial, roughly half enrolled, so overall participation was about 8%.
Unger and colleagues systematically reviewed studies that tracked consecutive cancer patients through the decision pathway to trial enrolment, quantifying structural, clinical and physician-or-patient barriers at each step. Thirteen studies (nine academic, four community) with 8,883 patients were pooled.
Structural barriers dominated: 55.6% of patients had no trial available for their cancer type and stage at their institution. Of the remainder, 21.5% were ineligible for the available trial. Physician and patient factors (not offered, or declined) accounted for 14.8%. Overall trial participation was 8.1%; but among patients who had an available trial and were eligible, about half enrolled. Participation was lower in community settings.
The analysis reframed low enrolment from a problem of patient reluctance to one of trial availability and eligibility criteria, shaping ASCO and FDA initiatives to broaden eligibility and decentralise trials.
Patients are not the bottleneck; trial access is. Bringing trials to community practices, loosening restrictive eligibility criteria and reducing site burden would do more for enrolment than patient education. Trials today reflect the minority of patients who happen to be treated where trials exist.
Shares AI trial matching & clinical decision support, Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
Shares AI trial matching & clinical decision support, Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
Shares AI trial matching & clinical decision support, Trials enrol too few, too slowly, Fragmented care and guideline gaps.
Shares Decentralised and hybrid clinical trials, Community oncology and site networks, AI trial matching & clinical decision support.
Shares AI trial matching & clinical decision support, Trials enrol too few, too slowly.
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly.
Shares Trials do not represent the people who get cancer, Trials enrol too few, too slowly.