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Notice

The Use of Bayesian Statistics in Medical Device Clinical Trials; Public Meeting

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the following public meeting: The Use of Bayesian Statistics in Medical Device Clinical Trials. The draft guidance entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials” provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials.

DATES:

The public meeting will be held on July 27, 2006, from 8:30 a.m. to 5 p.m. Registration for this meeting is required (see the Registration section of this document for details). Submit written or electronic comments on the draft guidance by August 21, 2006.

ADDRESSES:

The public meeting will be held at The Universities at Shady Grove, 9630 Gudelsky Dr., Rockville, MD. Additional information about and directions to the facility are available on the Internet at http://www.fda.gov/​cdrh/​meetings/​072706-bayesian.html. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Identify comments with the docket number found in brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Cindy Garris, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3150, ext. 121, FAX: 240-276-3151, e-mail: Cynthia.garris@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

I. Background

Bayesian statistics is a theory and approach to data analysis that provides a coherent method for learning from evidence as evidence accumulates. In situations where good information on clinical use of a device already exists, the Bayesian approach may enable FDA to reach the same decision on a device with a smaller-sized or shorter-duration pivotal trial. In other instances, a Bayesian approach can provide flexible methods for handling interim analyses and other modifications to trials. The draft guidance entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials” describes FDA's current thinking on statistical aspects of the design and analysis of medical device clinical trials that use Bayesian statistical methods. FDA announced the availability of the draft guidance on May 23, 2006 (71 FR 29651). The draft guidance is available at http://www.fda.gov/​cdrh/​osb/​guidance/​1601.html.

II. Agenda

FDA will provide presentations on the draft guidance entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials” in the morning. In the afternoon, panels will discuss the draft guidance. There will be opportunities for public participation throughout the day.

III. Registration

Online registration for the meeting is required. Acceptance will be on a first-registered, first-served basis. There are no assurances of onsite registration. Please register online at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfsud/​bayesian_​meeting.cfm.

FDA is pleased to provide the opportunity for interested persons to listen from a remote location to the live proceedings of the meeting. In order to ensure that a sufficient number of call-in lines are available, please register to listen to the meeting at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfsud/​bayesian_​meeting.cfm by July 21, 2006.

Persons without Internet access may call 240-276-3150, ext. 121, by July 21, 2006, to register for onsite meeting attendance or to register to listen to the meeting by phone. If you need special accommodations due to a disability, please contact Cindy Garris (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

IV. Request for Input and Materials

FDA is interested in receiving input from stakeholders on the draft guidance. Send suggestions or recommendations to the Division of Dockets Management (see ADDRESSES). FDA will place an additional copy of any material it receives on the docket (Docket No. 2006D-0191). Suggestions, recommendations, and materials may be seen at the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

V. Transcripts

Following the meeting, transcripts will be available for review at the Division of Dockets Management (see ADDRESSES).

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Dated: June 23, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 06-5804 Filed 6-26-06; 12:30 pm]

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