Characterization of Laboratory Eligibility Criteria in Phase III Oncology Trials: A Meta-Epidemiologic Analysis
Olivia O. Pocha, Avital M. Miller, Noah S. Meimoun, Jessica Liu, Ramez Kouzy, Timothy A. Lin, Pavlos Msaouel, Ethan B. Ludmir, Alexander D. SherryPURPOSE
Randomized clinical trials (RCTs) are crucial to the advancement of cancer treatment, yet clinical trial participation remains consistently low. Laboratory-based eligibility criteria can strongly influence patient enrollment; however, the prevalence and specificity of such criteria used in oncologic RCTs remain uncharacterized. To address this, we sought to characterize the prevalence, specificity, and trial-level factors associated with laboratory-based eligibility criteria.
METHODS
We conducted a meta-epidemiologic study of published phase III oncology RCTs registered on ClinicalTrials.gov. We assessed eligibility criteria for laboratory-based parameters including whether specific values were included. Multivariable logistic regression was used to evaluate the association of trial-level factors with study outcomes.
RESULTS
A total of 1,180 RCTs enrolling 889,541 patients were included. Among these, 63% (n = 740) included laboratory criteria. Of the 740, 47% (n = 351) used vague terminology without specified thresholds. Cooperative group trials were associated with higher odds of using laboratory eligibility criteria in general (adjusted odds ratios [aOR], 3.11 [95% CI, 2.17 to 4.44];
CONCLUSION
Although laboratory eligibility criteria are ubiquitous in phase III oncology RCTs, such criteria are often unspecified, which may affect enrollment and trial interpretation. Eligibility criteria of clinical trials should be tailored to those deemed essential for the safety and efficacy of participants undergoing the specific trial interventions.