Re-evaluating Clinical Trial Eligibility Criteria: Are We Excluding Viable Patients?

Researchers at The University of Texas MD Anderson Cancer Center posit that rigid protocols exclude stable patients from experimental therapies. This retrospective analysis focuses specifically on 509 screen-failed candidates with biliary tract or pancreatic cancer between August 2019 and November 2024.

Central to this investigation is the definition of clinical trial eligibility criteria, which dictates patient selection for safety and data integrity. While necessary for standardisation, the authors argue that overly stringent parameters may create an artificial cohort that fails to reflect the broader patient population found in routine practice. The dataset comprised 585 screen-failed individuals across 18 trials; however, 76 were removed due to incomplete records.

Impact of Clinical Trial Eligibility Criteria on Enrollment

Of the remaining 509 patients, the primary reasons for non-participation included patient refusal (19%), existing comorbidities (12%), and suboptimal organ function (11%). Notably, travel constraints and preference for standard care drove many patient refusals. However, the investigators identified 69 patients—representing 13.6% of the cohort—who were excluded due to 'potentially modifiable exclusions' (PMEs). These cases largely involved borderline laboratory abnormalities.

Specifically, liver function (23%), kidney function (20%), and platelet counts (12%) were cited as frequent barriers. Two independent oncologists validated these categorisations. The data indicates that minor deviations in lab results barred otherwise eligible candidates. Other PMEs included previous or concurrent malignancies (9%) and viral hepatitis (4%).

These findings suggest that current protocols might be unnecessarily restrictive regarding incidental or asymptomatic anomalies. By adjusting these thresholds, trial sponsors could potentially expand access. Nevertheless, one must note the study's retrospective nature and its restriction to two specific cancer types at a single tertiary centre. Broader applicability remains to be verified through multi-centre validation.