FDA Opens Eligibility for Cancer Clinical Trials to Younger Participants

Jul 13, 2020 by CenTrial



Clinical trials that aim to produce cancer treatments for pediatric patients are now able to include young participants in the actual trials. Until now, children were unable to access investigational cancer drugs during their trial period and had to wait for FDA approval after adult trials were concluded.

This process restricted the participants that were eligible for the trial and led to results that did not necessarily reflect the patient population the drugs were actually created for.

Restrictions are now eased for trials "when there is a clinical evidence or a strong scientific rationale to suggest that pediatric patients with a specific cancer diagnosis, histologic subtype, or tumor associated with the same relevant molecular target may benefit and when there is compelling nonclinical and/or adequate clinical information to sufficiently justify patient risk," according to the new guidelines.

However, before being allowed to participate, ethical, regulatory, and general considerations must be observed, and trial phases should be carefully matched to the patients' conditions.

"Broadening cancer trial eligibility criteria can maximize the generalizability of trial results," the guidelines continue, "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."

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