February 8, 2010 – The U.S. Food and Drug Administration (FDA) issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that 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 combined data may provide sufficient justification for smaller or shorter clinical 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," said FDA Commissioner Margaret A. Hamburg, M.D. "This is a terrific example of regulatory science in practice at FDA."

The FDA has substantial experience in the use of Bayesian statistical methods for the design and analysis of scientifically valid clinical studies. The FDA has approved a number of medical devices whose approval applications submitted to the FDA included clinical studies that used these 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 post-market studies.

The final document reflects public input gathered in 2006 after release of a draft of the guidance.

Healthcare payers are also contemplating the role Bayesian methods could play in making coverage decisions. In a June 2009 public meeting, the Medicare Evidence Development and Coverage Advisory Committee encouraged Medicare policymakers to consider Bayesian approaches when reviewing trials or technology assessments during the national coverage analysis process.
The FDA document can be found at: http://fda.gov/FDAgov/MedicalDevices/DeviceRegulationandGuidance/Guidan… ocuments/ucm071072.htm?SSContributor=true

For more information: www.cms.gov, www.fda.gov


Related Content

News | Breast Imaging

July 7, 2025 — SimonMed Imaging, one of the largest outpatient medical imaging providers in the United States, has ...

Time July 08, 2025
arrow
News | Image Guided Radiation Therapy (IGRT)

June 25, 2025 — Royal Philips and Indiana-based Methodist Hospitals recently announced the healthcare provider’s ...

Time June 25, 2025
arrow
News | PET-CT

June 23, 2025 — GE HealthCare’s commitment to advancing precision care in cardiology through its molecular imaging ...

Time June 23, 2025
arrow
News | Cardiac Imaging

May 20, 2025 — Royal Philips has launched the RADIQAL (Radiation Dose and Image Quality Trial) trial. This multicenter ...

Time May 27, 2025
arrow
News | Pediatric Imaging

May 13, 2025-- GE HealthCare recently announced the U.S. Food and Drug Administration (FDA) has approved a pediatric ...

Time May 20, 2025
arrow
News | Artificial Intelligence

April 16, 2025 — An artificial intelligence (AI) program trained to review images from a common medical test can detect ...

Time April 16, 2025
arrow
News | PET-CT

July 25, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET & PET-CT imaging ...

Time July 25, 2024
arrow
News | Radiology Imaging

July 23, 2024 — EMVision, an Australian medical device company focused on the development and commercialization of ...

Time July 23, 2024
arrow
Feature | SCCT | by Christine Book

June 27, 2024 — The countdown has begun for the Society of Cardiovascular Computed Tomography (SCCT) 19th Annual ...

Time June 27, 2024
arrow
News | PET Imaging

June 18, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET and PET-CT ...

Time June 18, 2024
arrow
Subscribe Now