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FDA Releases Draft Guidance on Use of Real-World Evidence for Drug & Biological Products

Life Science Connect

19 Jan 2022

Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product approvals, and post-approval monitoring of drugs.

“Overall, the draft guidance aligns with other steps FDA has undertaken, including the ongoing Complex Innovative Trial Design Pilot Meeting Program, which is intended to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs,” the authors wrote. “Such innovative trial designs offer the prospect of greater efficiency and smaller cohorts of participants by sharing control arms and studying multiple agents in the course of the same study.”

They added: “The goals of this draft guidance also appear to align with the industry guidance FDA issued for sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19 in which FDA has discussed how novel study design models can help researchers “do more with less” through more judicious use of human subjects in research and greater use or re-use of existing data sources. For instance, in the COVID-19 master protocol guidance, the agency has endorsed adoption of more complex research models that either share control arms, draw more heavily on existing data, or use data iteratively to refine the study on an ongoing basis, such as via Bayesian models in which results in one stage of a study can influence what variables or interventions are examined in the next. Master protocols are research plans that govern studies designed to examine multiple therapies, multiple diseases, or both, in the context of a single research study. In its guidance on the use of master protocols, the agency has articulated the potential public health benefits that could accrue from more flexible research designs, while emphasizing that with complexity can come increased risk of confusion or error. As the FDA has indicated its receptiveness to innovative research modalities, it has also made clear that its underlying high standards for scientific rigor remain unchanged.”

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