FDA Seeks to Streamline Clinical Trials

The U.S. Food and Drug Administration (FDA) has issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials, the agency said.

The Bayesian statistical method, which could result in less costly and more efficient patient studies, according to the agency, applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial.

“This final guidance on the use of Bayesian statistics is consistent with the FDA’s commitment to streamline clinical trials, when possible, in order to get safe and effective products to market faster,” said FDA Commissioner Margaret Hamburg, M.D. “This is a terrific example of regulatory science in practice at FDA.”

The FDA has approved several medical devices whose approval applications submitted to the agency included clinical studies thatusedthese statistical methods.

The final guidance, titled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials,” describes use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and difficulties with the Bayesian approach, and comparisons with standard statistical methods. The guidance also presents ideas for using Bayesian methods in post-market studies.

Click here to read the complete guidance.