Document ID: FDA-2011-N-0002-0082
Agency: fda
Document Type: Notice
Title: Review and Qualification of Clinical Outcome Assessments; Public Workshop
Posted Date: 2011-07-28T04:00Z

[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45271-45272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19140]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Review and Qualification of Clinical Outcome Assessments; Public 
Workshop

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.

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;

[[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.

    Dated: July 20, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19140 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P