Skip to Content

Notice

Review and Qualification of Clinical Outcome Assessments; Public Workshop

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer-reported outcome (ObsRO) measures. This public workshop is intended to provide information for and gain perspectives from patient advocates, health care providers, researchers, regulators, individuals from academia, industry, and other interested persons on various aspects of the development and implementation of COAs in the evaluation of treatment benefit. Regulatory review issues regarding context of use and documentation of the measurement properties of a COA will be covered during panel discussions. The input from this public workshop will be published in the form of a white paper or a series of manuscripts.

DATES:

Date and Time: The public workshop will be held on October 19, 2011, from 8:30 a.m. to 5 p.m. Participants are encouraged to arrive early to ensure time for parking and routine security check before the workshop.

Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/​AboutFDA/​WorkingatFDA/​BuildingsandFacilities/​WhiteOakCampusInformation/​ucm241740.htm. Attendees are responsible for their own accommodations.

The public workshop will also be available to be viewed online via Web cast at https://collaboration.fda.gov/​coaworkshop/​. Persons interested in participating by Web cast must register online by October 17, 2011.

Contact Person: Shauna Shupe, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6417, Silver Spring, MD 20993-0002, 301-796-0900, e-mail: Shauna.Shupe@fda.hhs.gov.

Registration: Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited to 150 attendees. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. Registration will close after the workshop is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m.

To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and FAX number) to COAworkshop@fda.hhs.gov. For those without Internet access, please call Shauna Shupe (see Contact Person) to register.

If you need special accommodations due to a disability, please contact Shauna Shupe at least 7 days in advance.

End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The Center for Drug Evaluation and Research (CDER) reviews COAs including PRO measures, (ClinRO) measures, and ObsRO measures when submitted with an investigational new drug application, a new drug application, or a biologics licensing application. The FDA guidance for industry entitled “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,” available at http://www.fda.gov/​downloads/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​UCM193282.pdf, explains how FDA reviews PRO measures.

CDER also reviews a COA when submitted for qualification as a drug development tool (DDT). Qualification of a COA is a regulatory determination that the COA is well-suited for a specific context of use in drug development. Following a public announcement of the qualification decision by FDA, the COA will be publicly available for use in any appropriate drug development program. Because the qualification process is separate from the drug marketing application process, qualification is conducive to public-private partnerships engaging in this COA development effort. Such collaborative approaches may increase the efficiency of COA development when more than one entity is interested in the use of a COA for a specific context of use. The FDA draft guidance for industry entitled “Qualification Process for Drug Development Tools,” available at http://www.fda.gov/​downloads/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​UCM230597.pdf, provides the draft process for CDER participation in the consultation, advice, and qualification review for COAs and other DDTs.

This workshop will focus on FDA review principles specific to all type of COAs, i.e., PRO, ClinRO, and ObsRO measures. More specifically, the workshop will provide researchers involved in the drug development process with information on the following topics concerning FDA review of COAs for treatment benefit evaluation:

  • COA measurement principles;
  • COA nomenclature;Start Printed Page 45272
  • Determination of COA context of use;
  • Practical considerations to develop and implement COAs to document treatment benefit; and
  • Description of interagency collaborations and public-private partnerships for COA development.

The Agency encourages patient advocates, health care providers, researchers, regulators, individuals from academia, industry, and other interested persons to attend this public workshop.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Transcripts will also be available on the Internet at http://www.fda.gov/​Drugs/​NewsEvents/​ucm206132.htm approximately 45 days after the workshop.

The workshop helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach activities by government Agencies to small businesses.

Start Signature

Dated: July 20, 2011.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.

End Signature End Supplemental Information

[FR Doc. 2011-19140 Filed 7-27-11; 8:45 am]

BILLING CODE 4160-01-P