The U.S. Food and Drug Administration (FDA) has issued guidance on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials that the agency says could result in less costly and more efficient patient studies.
The Bayesian statistical method applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial. The FDA noted that the combined data may provide "sufficient justification for smaller or shorter clinical studies."
The FDA has approved a number of medical devices whose approval applications submitted to the FDA included clinical studies that used the 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 postmarket studies.
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