Eligibility criteria and representative cancer clinical trials

Eligibility criteria in cancer clinical trials are intended to select the target population and limit the exposure of participants to foreseeable risks. In recent years there has been growing concern that these criteria may inadvertently limit representative participation, meaning that their restrictiveness is not justified by safety concerns. This limits the generalizability of trial data to the target population, which may have more comorbid conditions and other differential characteristics from those enrolled. There are few data, however, on the extent to which these criteria are overly restrictive or inappropriately liberal relative to safety data, or how variable justifications are across trials. Data are also limited on how these deficiencies impact the representation of the target population. In a series of studies, we assessed the extent to which cancer trial criteria are justified by safety data and, when compared to alternative criteria generated based on federal and expertise guidance and drug safety data known at study inception, how criteria restiveness impact representation of various demographic groups. We then look at various components of criteria and their use, such as copying-and-pasting criteria during trial development, and the impact of Duffy status on neutrophil count-related criteria.