Review of the CDRH/CBER Bayesian guidance

On Feb 5, 2010, the US Food and Drug Administration's Center for Devices and Radiological Health issued its Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. The appearance of this guidance represents another milestone in the agency's efforts to foster innovati...

Full description

Saved in:
Bibliographic Details
Published inJournal of GXP compliance Vol. 14; no. 2; p. 53
Main Author LeBlond, David
Format Journal Article
LanguageEnglish
Published North Olmsted UBM LLC 01.04.2010
Informa
Subjects
Bayesian analysis
Bayesian statistical decision theory
Clinical trials
Evaluation
FDA approval
Laws, regulations and rules
Medical equipment
Medical equipment and supplies industry
Medical test kit industry
Patient safety
Pharmaceutical industry
Pharmaceuticals
R&D
Research & development
United States
United States > US
Online AccessGet full text

Cover

More Information
Summary:On Feb 5, 2010, the US Food and Drug Administration's Center for Devices and Radiological Health issued its Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. The appearance of this guidance represents another milestone in the agency's efforts to foster innovation, science-based development, and knowledge building. Like the Center for Drug Evaluation and Research-sponsored process analytical technology guidance, process validation guidance, and International Conference on Harmonisation guidances before it, this new document is consistent with the agency's efforts to get safe and effective products to market faster. Also, in the spirit of these earlier efforts, it represents a paradigm shift toward a continuous learning approach to planning, monitoring, interpreting, and reporting clinical research. This new guidance grew out of the substantial experience the agency has had with Bayesian methodology in clinical trials. With its probabilistic foundation Bayesian thinking offers greater power and flexibility and provides results in a more natural and intuitive form.
ISSN:1552-5791
2150-6590