Reflecting the Real World of Cancer Care — The Impact of Broadening Trial Eligibility

Eligibility criteria are essential in cancer clinical trials to maximize patients' safety and to select a population likely to benefit. Criteria generally include laboratory values that estimate organ function, performance status (PS), and concurrent diagnoses or medications. However, overly stringent criteria can impede trial enrollment, exclude underrepresented groups, and limit the generalizability of results. In addition to unavailability of clinical trials, ineligibility for existing trials is a major barrier to participation.1 The American Society of Clinical Oncology and Friends of Cancer Research have developed consensus recommendations for eligibility criteria,2 and the National Cancer Institute's Cancer Therapy Evaluation Program has updated protocol templates to meet the need for modernized eligibility criteria.