Unger: most patients never get the chance to join a cancer trial, and when offered, half say yes
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.
- 55.6% of patients had no trial available at their site (95% CI 43.7-67.3)
- 21.5% were ineligible for available trials (95% CI 10.9-33.9)
- 14.8% did not enrol for physician or patient reasons (not offered, declined)
- Overall participation 8.1%; about 55% of eligible patients offered a trial enrolled
- Academic centres had higher participation (15.9%) than community sites (7.0%)
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.
- Included studies were heterogeneous and mostly US-based; barriers differ in single-payer and low-resource systems
- Studies varied in how they recorded reasons for non-enrolment, so barrier categories overlap
- Academic centres are over-represented in the source studies
- Does not capture racial, ethnic or socioeconomic disparities within each barrier category
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