publication date: Apr. 21, 2017

FDA: “Rational” expansion of eligibility criteria for clinical trials would accelerate drug development

Enrolling less homogeneous patient groups in clinical trials while maintaining safety may lead to a more accurate description of a drug’s safety and efficacy, FDA officials wrote in an article published April 20 in the New England Journal of Medicine.

The current method for structuring eligibility criteria for clinical trials can be unnecessarily restrictive—limiting accrual and access to trials, leading to studies with results that may not be fully representative of patient outcomes in a real-world, heterogeneous treatment setting, wrote Julia Beaver, Gwynn Ison, and Richard Pazdur.

Pazdur is director of the FDA Office of Hematology and Oncology Products as well as the Oncology Center of Excellence. Beaver is an associate director in OHOP’s Division of Oncology Products 1 and an assistant professor of oncology at Johns Hopkins University, and Ison is a medical officer at OHOP.

“Patient safety can be compromised if enrollment criteria are not rigorously considered,” the authors wrote. “However, a logical approach to defining eligibility could allow for detection of safety signals in early clinical trials that use broad eligibility criteria and permit modification of subsequent criteria throughout the drug-development process as knowledge emerges.”

This approach could incentivize pharmaceutical companies: including representative patient cohorts could, with broader indications, expand marketing claims, as well as reduce postmarketing requirements or commitments “for examining safety and pharmacokinetics in patients.”

Also, children could be enrolled in adult trials to study drugs in children as required by the Pediatric Research Equity Act, and to address incentives provided by the Best Pharmaceuticals for Children Act to develop pediatric drugs.

The authors provided five examples for a “more rational … Continue reading FDA: “Rational” expansion of eligibility criteria for clinical trials would accelerate drug development

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