The American Society of Clinical Oncology and Friends of Cancer Research published recommendations on how to achieve more inclusive enrollment in cancer clinical trials.
The recommendations, published in the Journal of Clinical Oncology (JCO), are in line with those first unveiled at the ASCO annual meeting and discussed at a stakeholders’ meeting with FDA in June. They outline five key areas where eligibility criteria can be broadened to expand enrollment to groups that are usually excluded from cancer trials, including patients with brain metastases, HIV-infected patients, children aged 12 and older, patients with current or prior malignancies, and those with organ damage (see BioCentury, June 9).
The organizations said they “will continue to work with clinical trial sponsors and regulators to turn these recommendations into action and identify additional opportunities to safely expand eligibility criteria for oncology trials.”
The recommendations were published in JCO as part of a “special series” addressing eligibility criteria in clinical trials. The series also includes an FDA analysis of IND applications from 2015, which found that eligibility criteria for current cancer clinical trials tend to narrowly define and limit study populations to lower-risk groups who may not represent the greater patient population. The authors suggest that broadened eligibility criteria would better reflect the real-world patient population, improve trial participation, and increase patients’ access to investigational treatments.