[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