82_FR_18376 82 FR 18303 - Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials; Public Workshop

82 FR 18303 - Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 73 (April 18, 2017)

Page Range18303-18304
FR Document2017-07766

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.

Federal Register, Volume 82 Issue 73 (Tuesday, April 18, 2017) 
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18303-18304]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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:

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

[[Page 18304]]

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

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

Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices 18303 Requests for Oral Comments: During sponsorship with the Critical Path health-related quality of life (HRQL). online registration you may indicate if Institute’s (C-Path) Patient-Reported PRO measures are one important type of you wish to provide a statement during Outcome (PRO) Consortium, is COA tool. There is growing interest in the Open Public Comment Period. We announcing a public workshop entitled optimizing the use of PRO measures to will do our best to accommodate ‘‘Second Annual Workshop on Clinical better incorporate the patient requests to make public comments Outcome Assessments in Cancer perspective into oncology drug based on time allocated for public Clinical Trials.’’ The purpose of the development. While PRO measures can comment. Individuals and organizations public workshop is to provide a forum be used to evaluate the efficacy of with common interests are urged to for collaborative multidisciplinary cancer treatments, there is increasing consolidate or coordinate their discussion to identify opportunities and interest in the use of PRO tools to assess comments, and request time for a joint address challenges for clinical outcome symptomatic side effects of treatment. presentation. Following the close of assessments, particularly patient- New PRO item banks and libraries are registration date, we will determine the reported outcome (PRO) assessments, in becoming available that can provide amount of time allotted to each oncology drug development. In this needed flexibility to tailor the PRO commenter and the approximate time public workshop, a broad array of assessment to the wide range of side each oral comment is scheduled to international stakeholders involved in effects seen with the various begin; commenters should arrive ahead oncology drug development and PRO mechanistic classes utilized in of their scheduled time in case the measurement will provide perspectives contemporary drug development. FDA agenda moves ahead of schedule so as on the role of PRO measures to provide is interested in gaining feedback on to be sure not to forfeit their speaking complementary clinical data on the methods to integrate the patient into the time. All requests to make oral symptomatic side effects of anti-cancer assessment of safety and tolerability of comments must be received by the close agents. Speakers and panelists will cancer drugs through systematic patient- of registration on May 1, 2017. No explore the utility of information reporting of side effects during clinical commercial or promotional material derived from existing and emerging PRO trials. This public workshop will will be permitted to be presented or measures and discuss potential ways to discuss standard clinician reporting of distributed at the public workshop. improve the collection, analysis, and adverse events, the development and Streaming Webcast of the Public presentation of the data to support drug implementation of the PRO-Common Workshop: This public workshop will development and better inform Terminology Criteria for Adverse Events also be Webcast. Additional information treatment decisions. In addition, (CTCAE) assessment tool, and explore will be made available regarding workshop participants will discuss different analysis and presentation accessing the Webcast 2 days prior to possible approaches to the patient- methods for longitudinal patient- the public workshop at http:// reported assessment of an reported adverse event data. www.fda.gov/Drugs/NewsEvents/ investigational drug’s overall side effect II. Registration and Accommodations ucm538047.htm. burden as a clinical trial endpoint. This Transcripts: Please be advised that as public workshop will include speakers A. Registration soon as a transcript of the public and panelists from regulatory agencies, There is a registration fee to attend workshop is available, it will be academia, patient advocacy groups, and this public workshop. The registration accessible at https:// the medical product industry. fee is charged to help defray the costs www.regulations.gov. It may be viewed DATES: The public workshop will be of the public workshop facility, speaker at the Division of Dockets Management held on April 25, 2017, from 8 a.m. to and panelist expenses, audiovisual (see ADDRESSES). A link to the 5 p.m. See the SUPPLEMENTARY equipment, materials, and food. Persons transcript will also be available on the INFORMATION section for registration date interested in attending this public Internet at http://www.fda.gov/Drugs/ and information. workshop must register by April 21, NewsEvents/ucm538047.htm. 2017. If time and space permit, onsite ADDRESSES: The public workshop will Dated: April 13, 2017. be held at the Hyatt Regency Bethesda, registration on the day of the public Anna K. Abram, One Bethesda Metro Center, 7400 workshop will be provided beginning at Deputy Commissioner for Policy, Planning, Wisconsin Ave., Bethesda, MD 20814, 8 a.m. Seats are limited, and registration Legislation, and Analysis. 301–657–1234. will be on a first-come, first-served [FR Doc. 2017–07821 Filed 4–17–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: basis. BILLING CODE 4164–01–P Theresa Hall, Patient-Reported Outcome To register for the public workshop, Consortium, Critical Path Institute, 1730 please complete registration online at East River Road, Tucson, AZ 85718, https://www.cvent.com/events/second- DEPARTMENT OF HEALTH AND 520–777–2875, FAX: 525–547–3456, annual-workshop-on-clinical-outcome- HUMAN SERVICES email: thall@c-path.org; and Valerie assessments-coas-in-cancer-clinical- Vashio, Center for Drug Evaluation and trials/registration-270d8a5ee3ae4a Food and Drug Administration 108938851e2a7d0ea7.aspx. (FDA has Research, Food and Drug [Docket No. FDA–2017–N–1989] Administration, 10903 New Hampshire verified the Web site addresses, as of the Ave., Silver Spring, MD 20993, 301– date this document publishes in the Second Annual Workshop on Clinical 796–3710, FAX: 301–796–9909, email: Federal Register, but Web sites are Outcome Assessments in Cancer valerie.vashio@fda.hhs.gov. subject to change over time.) The costs Clinical Trials; Public Workshop of registration for the different sradovich on DSK3GMQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: categories of attendees are as follows: AGENCY: Food and Drug Administration, I. Background HHS. Category Cost ACTION: Notice of public workshop. Clinical outcome assessment (COA) tools are intended to capture how Industry Representa- $400. SUMMARY: The Food and Drug patients experience a disease and its tives. Administration’s (FDA’s) Center for treatment by assessing symptoms, Charitable Nonprofit/ $100 (Contact C- Drug Evaluation and Research, in co- function, and other aspects of a patient’s Academic. Path). VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1

18304 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices Category Cost DEPARTMENT OF HEALTH AND OMB No. 0937–0198—Extension— HUMAN SERVICES Office of Resource Integrity. Government .............. $100 (Contact C- OMB No.: 0937–0198. Path). Office of the Secretary Abstract: This is a request to extend the currently approved collection, OMB B. Accommodations [Document Identifier: 0937–0198–30D] No. 0937–0198, which involves two forms: PHS–6349 and PHS–6315. The Attendees are responsible for their Agency Information Collection purpose of the Institutional Assurance own hotel accommodations. Attendees Activities; Submission to OMB for and Annual Report on Possible Research making reservations at the Hyatt Review and Approval; Public Comment Misconduct form (PHS–6349) is to Regency Bethesda, One Bethesda Metro Request provide data on the amount of research Center, Bethesda, MD 20814, are eligible AGENCY: Office of the Secretary, HHS. misconduct activity occurring in for a reduced rate of $249 per night, not institutions conducting PHS-supported including applicable taxes. To receive ACTION: Notice. research, as well as providing an annual the reduced rate, please contact the SUMMARY: In compliance with the assurance that those institutions have hotel directly at 301–657–1234 and Paperwork Reduction Act of 1995, the established and will follow reference the Critical Path Institute Office of the Secretary (OS), Department administrative policies and procedures April 2017 workshop or book online at: of Health and Human Services, has for responding to allegations of research https://aws.passkey.com/event/ submitted an Information Collection misconduct that comply with the Public 15624700/owner/14877/landing? Request (ICR), described below, to the Health Service (PHS) Regulations on gtid=8d00149fbdf860c0e824aee Office of Management and Budget Research Misconduct (42 CFR part 93). 45de33531. (OMB) for review and approval. The ICR The purpose of the Assurance of is for renewal of the approved Compliance by Sub-Award Recipients If you need special accommodations form (PHS–6315) is to establish a due to a disability, please contact the information collection assigned OMB control number <OCN>, scheduled to similar assurance of compliance with 42 Hyatt Regency Bethesda at least 7 days CFR part 93 for sub-awardee expire on <expiration date>. Comments in advance. institutions, as well as provide data on submitted during the first public review III. Transcripts of this ICR will be provided to OMB. the amount of research misconduct OMB will accept further comments from activity occurring in those sub-awardee Transcripts will not be available. the public on this ICR during the review institutions. Research misconduct is Presentations and associated audio files and approval period. defined as receipt of an allegation of will be available on the C-Path Web site DATES: Comments on the ICR must be research misconduct and/or the conduct approximately 30 days after the public received on or before May 18, 2017. of an inquiry and/or investigation into workshop at https://c-path.org/category/ such allegations. These data enable the ADDRESSES: Submit your comments to events/. ORI to monitor institutional compliance OIRA_submission@omb.eop.gov or via with the PHS regulation. Lastly, the Dated: April 12, 2017. facsimile to (202) 395–5806. forms will be used to respond to Anna K. Abram, FOR FURTHER INFORMATION CONTACT: congressional requests for information Deputy Commissioner for Policy, Planning, Information Collection Clearance staff, to prevent misuse of Federal funds and Legislation, and Analysis. Information.CollectionClearance@ to protect the public interest. [FR Doc. 2017–07766 Filed 4–17–17; 8:45 am] hhs.gov or (202) 795–7714. Need and Proposed Use of the BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: When Information: Public Health Service submitting comments or requesting Polices on Research Misconduct (42 information, please include the OMB CFR part 93)—OMB No. 0937–0198— control number 0937–0198 and Extension—Office of Research Integrity. document identifier 0937–0198–30D for Likely Respondents: PHS awardee and reference. sub-awardee institutions. Information Collection Request Title: The total annual burden hours Public Health Service Polices on estimated for this ICR are summarized Research Misconduct (42 CFR part 93)— in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Average Number of Number of burden per Total burden Form name responses per respondents response hours respondent (in hours) PHS–6349 ........................................................................................................ 5,435 1 10/60 906 PHS–6315 ........................................................................................................ 200 1 5/60 17 Total .......................................................................................................... ........................ ........................ ........................ 923 sradovich on DSK3GMQ082PROD with NOTICES Terry S. Clark, Asst Information Collection Clearance Officer. [FR Doc. 2017–07787 Filed 4–17–17; 8:45 am] BILLING CODE 4150–31–P VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 9990 E:\FR\FM\18APN1.SGM 18APN1


Document Created: 2017-04-17 23:59:59
Document Modified: 2017-04-17 23:59:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop.
DatesThe 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.
ContactTheresa Hall, Patient-Reported Outcome Consortium, Critical Path Institute, 1730 East River Road, Tucson, AZ 85718, 520-777-2875, FAX: 525-547-3456, email: [email protected]; 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]
FR Citation82 FR 18303 
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