FDA Releases Draft Guidelines Encouraging Rational Extended Eligibility of Patients for Oncology Clinical Trials
The following quote is attributed to Richard Pazdur, MD, director of the FDA Center of Excellence in Oncology and Acting Director of the Office of Oncologic Diseases of the FDA Center for Drug Evaluation and Research:
Today, the FDA released a draft guideline encouraging industry to include patients with incurable cancers (when there is no potential for cure or prolonged / near-normal survival) in cancer clinical trials. whether or not they received existing alternative treatment options. Historically, many clinical trials have required participating patients to first receive multiple therapies.
The FDA believes that patients with incurable cancers, if given adequate information to make an informed decision, should be eligible to participate in clinical oncology trials. If there is no scientific justification for excluding these patients, the eligibility criteria for clinical trials should be broadened to include these patients, with appropriate informed consent.
This guidance project is part of the FDA’s larger initiative to encourage rational expanded eligibility of patients for oncology clinical trials. “
- Today, the United States Food and Drug Administration released a draft guidance document, “Eligibility Criteria for Clinical Trials in Cancer: Therapy Available in Non-Curative Settings,” which, when finalized, provide recommendations to sponsors designing clinical trials of drugs and biologics to extend eligibility to patients with incurable cancers.
- The draft guidance, when finalized, will provide sponsors with recommendations regarding the inclusion of patients who did not receive available therapies, such as evaluating these patients in separate cohorts of patients who received therapies. available.
United States Food and Drug Administration