FDA Issues Guidelines to Speed Up Medical Device Trials

8 February 2010 (Last Updated February 8th, 2010 18:30)

The US Food and Drug Administration (FDA) has issued new guidance on the design and analysis of medical device clinical trials aimed at improving efficiency and cutting costs. The guidelines issued promote the use of the Bayesian statistical method, which applies an algorithm that makes

The US Food and Drug Administration (FDA) has issued new guidance on the design and analysis of medical device clinical trials aimed at improving efficiency and cutting costs.

The guidelines issued promote the use of the Bayesian statistical method, which applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial.

Crucially, this provides sufficient justification for smaller or shorter clinical studies.

The guidance describes the use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and difficulties of the Bayesian approach, and comparisons with standard statistical methods.

The guidance also presents ideas for using Bayesian methods in post-market studies.

This final guidance on the use of Bayesian statistics is consistent with the FDA's commitment to streamline clinical trials when possible, to get safe and effective products to market faster, the FDA said.