News | February 08, 2010

FDA Issues Guidance to Help Streamline Medical Device Clinical Trials

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/GuidanceD ocuments/ucm071072.htm?SSContributor=true

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

Related Content

Siemens Healthineers, Florida Hospital Collaborate to Improve Health Care Outcomes
News | CT Angiography (CTA) | January 23, 2018
January 23, 2018 – Siemens Healthineers and Florida Hospital, part of Adventist Health System, have announced a multi
CT Shows Enlarged Aortas in Former Pro Football Players

3-D rendering from a cardiac CT dataset demonstrating mild dilation of the ascending aorta.

News | Computed Tomography (CT) | January 11, 2018
Former National Football League (NFL) players are more likely to have enlarged aortas, a condition that may put them at...
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Imaging | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
Toshiba Medical Systems Changes Name to Canon Medical Systems Corp.
News | Business | January 08, 2018
Canon Inc. and Canon Medical Systems Corp. announced the official corporate name (trade name) change of Canon Group...
New International Report Provides Comprehensive Guide to Imaging in Chagas Heart Disease
News | Cardiovascular Ultrasound | January 03, 2018
Chagas disease (ChD), an infectious parasitic disease transmitted primarily by triatomine insects, has become a...
ACR Appropriateness Criteria Adds and Revises Topics for December 2017
News | Clinical Decision Support | December 29, 2017
December 29, 2017 — Radiologists can enhance the quality and effectiveness of care with the newest release of the ACR
BlueCross BlueShield Companies in Eight States Issue Positive Medical Policies for HeartFlow FFRct Analysis
News | CT Angiography (CTA) | December 28, 2017
HeartFlow Inc. announced that Health Care Service Corp. (HCSC), which operates Blue Cross and Blue Shield plans in five...
Siemens Healthineers Strengthens CT Portfolio With Four New Systems at RSNA 2017

The Somatom Force with the new FAST 3-D Camera

Technology | Computed Tomography (CT) | December 14, 2017
Siemens Healthineers introduced four new computed tomography (CT) scanners across two platforms at the 2017...
Toshiba Medical Introduces Aquilion Prime SP CT System at RSNA 2017
Technology | Computed Tomography (CT) | December 13, 2017
Toshiba Medical, a Canon Group company, introduced its new Aquilion Prime SP computed tomography (CT) system at the...
Toshiba Vantage Galan 3T XGO Edition MRI Features New Advanced Gradient

MRI of the brain performed on the Galan 3T utilizing the 32-channel Head SPEEDER Coil

Technology | Magnetic Resonance Imaging (MRI) | December 11, 2017
Toshiba Medical, a Canon Group company, demonstrated the Vantage Galan 3T XGO Edition with the all-new Saturn X...
Overlay Init