FDA Recommendations Help Streamline Medical Device Clinical Trials

The FDA announced this week guidelines for medical device clinical trials that could result in less costly and more efficient patient trials.  The agency endorsed the use of the Bayesian statistical methods in clinical trial data assessments.  Bayesian statistical methods apply an algorithm that makes it possible to combine data collected in previous trials with data collected in a current trial.  This combined data may provide sufficient justification for smaller or shorter clinical studies.  Bayesian statistical methods base probabilities of future outcomes on results of previous studies. 

“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,” says Margaret A. Hamburg, MD and FDA commissioner. 

This announcement comes amid concerns that the FDA will be revamping its 510(k) fast-track approval pathway for medical devices.  The 510(k) pathway, also known as the premarket notification process, doesn’t require the level of medical evidence as a full premarket approval, thus it is a faster and less costly approach to FDA approval.  According to the FDA, the 510(k) pathway was instituted 30 years ago to make available safe and effective devices while promoting industry innovation.

“During the past three decades, technology and the medical device industry have changed dramatically making it an appropriate time for the FDA to review the adequacy of the premarket notification program in meeting these two goals,” the agency released in a statement.

The FDA has commissioned the Institute of Medicine to review the process and has also formed an internal working group to study and strengthen the program.  There will be a public meeting to discuss 510(k) challenges on February 18, 2010. 
For more on the Bayesian statistical method story, click here
For more on the 510(k) pathway review, click here