FDA issues guidance to streamline the clinical trials on medical devices

The final document reflects public comments collected in 2006 after the release of the draft guidelines.– Recommendations for the use of Bayesian statistics in clinical trials Medical Device

Payers of health care are also contemplating the potential role of Bayesian decision making in coverage. On 1 June 2009 public meeting, the development and coverage given by the Advisory Committee encourages the politicians to take Medicare into account when considering Bayesian approaches to testing or technology assessments in the process of analysis of national coverage.

The Definitive Guide to the use of Bayesian statistics is consistent with FDA’s commitment to streamline the clinical trials, where possible, to obtain safe and effective products to market more quickly, said FDA Commissioner Margaret A. Hamburg, MD This is a great example of regulatory science, in practice, to the FDA.

[I] Regulation No 1901/2006 of the European Parliament and of the Council on medicinal products for pediatric use, as amended by Regulation No 1902/2006.

The final guidelines entitled Guidelines for the use of Bayesian statistics in clinical trials of medical device , describes the use of Bayesian methods, the design and analysis of clinical trials of medical devices, the advantages and difficulties Bayesian approach, and comparisons with statistical methods.

The orientation also has ideas for the use of Bayesian methods in post-marketing studies.