Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs
Guidance for industry
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Medical Products and Tobacco. Oncology Center of Excellence, issuing body.
Center for Biological Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of pediatric patients (i.e., children and adolescents) when appropriate. This guidance is intended to assist stakeholders, including sponsors and institutional review boards (IRBs), responsible for the development and oversight of clinical trials. A clinical trial's eligibility criteria (for inclusion and exclusion) are essential components of the trial, defining the characteristics of the study population. Because there is variability in investigational drugs and trial objectives, eligibility criteria should be developed taking into consideration the mechanism of action of the drug, the targeted disease or patient population, the anticipated safety of the investigational drug, the availability of adequate safety data, and the ability to recruit trial participants from the patient population to meet the objectives of the clinical trial. However, some eligibility criteria have become commonly accepted over time or used as a template across trials without clear scientific or clinical rationale. Unnecessarily restrictive eligibility criteria may slow patient accrual, limit patients' access to clinical trials, and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug. Broadening cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy's benefit-risk profile across the patient population likely to use the drug in clinical practice and should be considered to avoid jeopardizing patient safety. Early evaluation and development of potentially effective drugs, particularly targeted drugs, in pediatric patients may provide information on safe and effective use, therefore reducing risks associated with off label use, and accelerate the development of effective, innovative therapies for pediatric patients.
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