[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18303-18304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1989]


Second Annual Workshop on Clinical Outcome Assessments in Cancer 
Clinical Trials; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug 
Evaluation and Research, in co-sponsorship with the Critical Path 
Institute's (C-Path) Patient-Reported Outcome (PRO) Consortium, is 
announcing a public workshop entitled ``Second Annual Workshop on 
Clinical Outcome Assessments in Cancer Clinical Trials.'' The purpose 
of the public workshop is to provide a forum for collaborative 
multidisciplinary discussion to identify opportunities and address 
challenges for clinical outcome assessments, particularly patient-
reported outcome (PRO) assessments, in oncology drug development. In 
this public workshop, a broad array of international stakeholders 
involved in oncology drug development and PRO measurement will provide 
perspectives on the role of PRO measures to provide complementary 
clinical data on the symptomatic side effects of anti-cancer agents. 
Speakers and panelists will explore the utility of information derived 
from existing and emerging PRO measures and discuss potential ways to 
improve the collection, analysis, and presentation of the data to 
support drug development and better inform treatment decisions. In 
addition, workshop participants will discuss possible approaches to the 
patient-reported assessment of an investigational drug's overall side 
effect burden as a clinical trial endpoint. This public workshop will 
include speakers and panelists from regulatory agencies, academia, 
patient advocacy groups, and the medical product industry.

DATES: The public workshop will be held on April 25, 2017, from 8 a.m. 
to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration 
date and information.

ADDRESSES: The public workshop will be held at the Hyatt Regency 
Bethesda, One Bethesda Metro Center, 7400 Wisconsin Ave., Bethesda, MD 
20814, 301-657-1234.

FOR FURTHER INFORMATION CONTACT: Theresa Hall, Patient-Reported Outcome 
Consortium, Critical Path Institute, 1730 East River Road, Tucson, AZ 
85718, 520-777-2875, FAX: 525-547-3456, email: path.org">thall@c-path.org; and 
Valerie Vashio, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3710, FAX: 301-796-9909, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Clinical outcome assessment (COA) tools are intended to capture how 
patients experience a disease and its treatment by assessing symptoms, 
function, and other aspects of a patient's health-related quality of 
life (HRQL). PRO measures are one important type of COA tool. There is 
growing interest in optimizing the use of PRO measures to better 
incorporate the patient perspective into oncology drug development. 
While PRO measures can be used to evaluate the efficacy of cancer 
treatments, there is increasing interest in the use of PRO tools to 
assess symptomatic side effects of treatment. New PRO item banks and 
libraries are becoming available that can provide needed flexibility to 
tailor the PRO assessment to the wide range of side effects seen with 
the various mechanistic classes utilized in contemporary drug 
development. FDA is interested in gaining feedback on methods to 
integrate the patient into the assessment of safety and tolerability of 
cancer drugs through systematic patient-reporting of side effects 
during clinical trials. This public workshop will discuss standard 
clinician reporting of adverse events, the development and 
implementation of the PRO-Common Terminology Criteria for Adverse 
Events (CTCAE) assessment tool, and explore different analysis and 
presentation methods for longitudinal patient-reported adverse event 
data.

II. Registration and Accommodations

A. Registration

    There is a registration fee to attend this public workshop. The 
registration fee is charged to help defray the costs of the public 
workshop facility, speaker and panelist expenses, audiovisual 
equipment, materials, and food. Persons interested in attending this 
public workshop must register by April 21, 2017. If time and space 
permit, onsite registration on the day of the public workshop will be 
provided beginning at 8 a.m. Seats are limited, and registration will 
be on a first-come, first-served basis.
    To register for the public workshop, please complete registration 
online at https://www.cvent.com/events/second-annual-workshop-on-clinical-outcome-assessments-coas-in-cancer-clinical-trials/registration-270d8a5ee3ae4a108938851e2a7d0ea7.aspx. (FDA has verified 
the Web site addresses, as of the date this document publishes in the 
Federal Register, but Web sites are subject to change over time.) The 
costs of registration for the different categories of attendees are as 
follows:

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                 Category                               Cost
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Industry Representatives..................  $400.
Charitable Nonprofit/Academic.............  $100 (Contact C-Path).

[[Page 18304]]

 
Government................................  $100 (Contact C-Path).
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B. Accommodations

    Attendees are responsible for their own hotel accommodations. 
Attendees making reservations at the Hyatt Regency Bethesda, One 
Bethesda Metro Center, Bethesda, MD 20814, are eligible for a reduced 
rate of $249 per night, not including applicable taxes. To receive the 
reduced rate, please contact the hotel directly at 301-657-1234 and 
reference the Critical Path Institute April 2017 workshop or book 
online at: https://aws.passkey.com/event/15624700/owner/14877/landing?gtid=8d00149fbdf860c0e824aee45de33531.
    If you need special accommodations due to a disability, please 
contact the Hyatt Regency Bethesda at least 7 days in advance.

III. Transcripts

    Transcripts will not be available. Presentations and associated 
audio files will be available on the C-Path Web site approximately 30 
days after the public workshop at https://c-path.org/category/events/.

    Dated: April 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07766 Filed 4-17-17; 8:45 am]
 BILLING CODE 4164-01-P