Eligibility for clinical trials historically has been very conservative and included exclusion criteria that prevented or limited some patients with cancer from enrolling.
However, on October 2, 2017, the American Society of Clinical Oncology, Friends of Cancer Research, and the Food and Drug Administration published clinical trial eligibility recommendations in a special issue of the Journal of Clinical Oncology that aim to broaden who can be accepted into clinical trials.
The groups noted that excessively restrictive eligibility criteria can extend the time to accrue patients, limit the generalizability of the trial results, and compromise information on the trial’s benefit-risk profile.
They examined specific eligibility criteria including the presence of brain metastases, minimum age for clinical trial enrollment, presence of HIV infection or organ dysfunction, and prior and concurrent malignancies.
Consensus recommendations were formulated, based on an evidence-based review, consideration of patient populations, and consultation with the research community.
The researchers determined that patients with treated or clinically stable brain metastases should be routinely included in trials, and only excluded if there is compelling rationale.
In initial dose-finding trials, pediatric-specific cohorts need to be included based on strong scientific rationale for benefit. Later phase trials in diseases that span adult and pediatric populations should include patients older than 12 years.
HIV-infected patients who are healthy and have low risk of AIDS-related outcomes should be included absent specific rationale for exclusion. Renal function criteria should enable liberal creatinine clearance, unless the investigational agent involves renal excretion.
Patients with prior or concurrent malignancies should be included, especially when the risk of the malignancy interfering with either safety or efficacy endpoints is very low.
The groups noted that clinical trial enrollment criteria should strive for inclusiveness and exclusion criteria should be evidence-based.