83 FR 4210 - Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

Page Range		4210-4211
FR Document		2018-01643

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Evaluating Inclusion and Exclusion Criteria in Clinical Trials.'' Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.

Federal Register, Volume 83 Issue 20 (Tuesday, January 30, 2018)

[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4210-4211]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01643]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0129]


Evaluating Inclusion and Exclusion Criteria in Clinical Trials; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing a public meeting entitled ``Evaluating Inclusion and 
Exclusion Criteria in Clinical Trials.'' Convened by the Duke-Robert J. 
Margolis, MD, Center for Health Policy at Duke University and supported 
by a cooperative agreement with FDA, the purpose of the public meeting 
is to bring the stakeholder community together to discuss a variety of 
topics related to eligibility criteria in clinical trials and their 
potential impact on patient access to investigational drugs, and how to 
facilitate the enrollment of a diverse patient population.

DATES: The public meeting will be held on April 16, 2018, from 8:30 
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at the National Press Club, 
529 14th St. NW, Washington, DC 20045. For additional travel and hotel 
information, please refer to the following website: https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials. There will also be a live webcast for those 
unable to attend the meeting in person (see Streaming Webcast of the 
Public Meeting).

FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796-
2500, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    This public meeting implements FDA's mandate under section 610 of 
the FDA Reauthorization Act of 2017 to convene a public meeting to 
discuss clinical trial inclusion and exclusion criteria that will 
ultimately inform an FDA guidance on this subject. Among other things, 
the public meeting will include discussion about various ways in which 
participation in clinical trials can be improved, including through 
alternative trial designs and expanded access trials (see Section II. 
Topics for Discussion at the Public Meeting).
    Inclusion of relevant subpopulations in drug development programs 
helps ensure that approved products will be safe and effective for the 
population likely to be treated when the drug is marketed. However, 
certain eligibility criteria in clinical trials can exclude patient 
subgroups, resulting in the enrollment of study populations that may 
not be fully representative of that broader patient population. FDA has 
and will continue its efforts to encourage greater diversity in 
clinical trial populations. For example, FDA regulations require 
marketing applications to provide analyses of safety and effectiveness 
by demographic and other relevant subgroups (see 21 CFR 
314.50(d)(5)(v)). In addition, in 2016, FDA published guidance on the 
collection of race and ethnicity data in clinical trials (available on 
FDA's guidance web page at https://www.fda.gov/downloads/

[[Page 4211]]

regulatoryinformation/guidances/ucm126396.pdf).

II. Topics for Discussion at the Public Meeting

    Topics for discussion during this meeting include:
     The risks and benefits of participation in clinical trials 
as well as potential regulatory, geographical, and socioeconomic 
barriers to participation.
     the rationale for eligibility criteria in clinical trials, 
as well as the impact of exclusion criteria on the enrollment of 
populations, such as infants, children, pregnant and lactating women, 
elderly, individuals with advanced disease, and individuals with co-
morbid conditions.
     alternative clinical trial designs that may increase 
enrollment of more diverse patient populations, while facilitating the 
collection of data to establish safety and effectiveness.
     how appropriate patient populations can benefit from the 
results of trials that employ alternative designs.
     how changes to eligibility criteria may impact the 
complexity and length of clinical trials, as well as the strength of 
data necessary to demonstrate safety and effectiveness.
     opportunities for using data from expanded access trials.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone. Registration is free and 
based on space availability, with priority given to early registrants. 
Persons interested in attending this public meeting must register by 
April 12, 2018, midnight Eastern Time. There will be no onsite 
registration. Early registration is recommended because seating is 
limited; therefore, FDA may limit the number of participants from each 
organization. Registrants will receive confirmation when they have been 
accepted. Duke-Margolis will post on its website if registration closes 
before the day of the public meeting.
    If you need special accommodations due to a disability, please 
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy, 
202-791-9561, [email protected], no later than April 12, 2018.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast; archived video footage will be available at the Duke-
Margolis website (https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials) following the 
meeting. Organizations are requested to register all participants, but 
to view using one connection per location whenever possible. Webcast 
participants will be sent technical system requirements in advance of 
the event. Prior to joining the streaming webcast of the public 
workshop, we recommend that you review these technical system 
requirements in advance.
    Transcripts: Please be advised that transcripts will not be 
available.
    FDA has verified the website addresses in this document, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.
    Meeting Materials: All event materials will be provided to 
registered attendees via email prior to the workshop and publicly 
available at the Duke-Margolis website: https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01643 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P

4210 Federal Register / Vol. 83, No. 20 / Tuesday, January 30, 2018 / Notices

• Progress toward Meeting Legislatively The proposed data collection form is on the progress of their program to the
Mandated Benchmark Requirements as follows: Secretary, depending on the reporting
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ANNUAL BURDEN ESTIMATES
Number of
Annual Average
responses Total Total annual
Instrument number of burden hours
per responses burden hours
respondents per response
respondent

Annual/Final Report to the Secretary (depending on re-
porting period) .................................................................. 25 1 1 50 1250

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
Hours: 1,250. HUMAN SERVICES Dianne Paraoan, Center for Drug
In compliance with the requirements Evaluation and Research, Food and
Food and Drug Administration Drug Administration, 10903 New
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Hampshire Ave., Bldg. 51, Rm. 3326,
[Docket No. FDA–2018–N–0129]
Silver Spring, MD 20993, 301–796–
Administration for Children and
Evaluating Inclusion and Exclusion 2500, Dianne.Paraoan@fda.hhs.gov.
Families is soliciting public comment
on the specific aspects of the Criteria in Clinical Trials; Public SUPPLEMENTARY INFORMATION:
information collection described above. Meeting
I. Background
Copies of the proposed collection of AGENCY: Food and Drug Administration, This public meeting implements
information can be obtained and HHS. FDA’s mandate under section 610 of the
comments may be forwarded by writing ACTION: Notice of public meeting. FDA Reauthorization Act of 2017 to
to the Administration for Children and convene a public meeting to discuss
Families, Office of Administration, SUMMARY: The Food and Drug clinical trial inclusion and exclusion
Office Planning, Research and Administration (FDA, the Agency, or criteria that will ultimately inform an
Evaluation, 370 L’Enfant Promenade we) is announcing a public meeting FDA guidance on this subject. Among
SW, Washington, DC 20447, Attn: ACF entitled ‘‘Evaluating Inclusion and other things, the public meeting will
Reports Clearance Officer. Email Exclusion Criteria in Clinical Trials.’’ include discussion about various ways
address: infocollection@acf.hhs.gov. All Convened by the Duke-Robert J. in which participation in clinical trials
requests should be identified by the title Margolis, MD, Center for Health Policy can be improved, including through
of the information collection. at Duke University and supported by a alternative trial designs and expanded
cooperative agreement with FDA, the access trials (see Section II. Topics for
The Department specifically requests purpose of the public meeting is to bring
comments on: (a) Whether the proposed Discussion at the Public Meeting).
the stakeholder community together to Inclusion of relevant subpopulations
collection of information is necessary discuss a variety of topics related to
for the proper performance of the in drug development programs helps
eligibility criteria in clinical trials and ensure that approved products will be
functions of the agency, including their potential impact on patient access
whether the information shall have safe and effective for the population
to investigational drugs, and how to likely to be treated when the drug is
practical utility; (b) the accuracy of facilitate the enrollment of a diverse marketed. However, certain eligibility
theagency’s estimate of the burden of patient population. criteria in clinical trials can exclude
the proposed collection of information; DATES: The public meeting will be held patient subgroups, resulting in the
(c) the quality, utility, and clarity of the on April 16, 2018, from 8:30 a.m. to 5 enrollment of study populations that
information to be collected; and (d) p.m. See the SUPPLEMENTARY may not be fully representative of that
ways to minimize the burden of the INFORMATION section for registration date broader patient population. FDA has
collection of information on and information. and will continue its efforts to
respondents, including through the use ADDRESSES: The public meeting will be encourage greater diversity in clinical
of automated collection techniques or held at the National Press Club, 529 trial populations. For example, FDA
other forms of information technology. 14th St. NW, Washington, DC 20045. regulations require marketing
Consideration will be given to For additional travel and hotel applications to provide analyses of
comments and suggestions submitted information, please refer to the safety and effectiveness by demographic
daltland on DSKBBV9HB2PROD with NOTICES

within 60 days of this publication. following website: https:// and other relevant subgroups (see 21
healthpolicy.duke.edu/events/ CFR 314.50(d)(5)(v)). In addition, in
Robert Sargis,
evaluating-inclusion-and-exclusion- 2016, FDA published guidance on the
Reports Clearance Officer. criteria-clinical-trials. There will also be collection of race and ethnicity data in
[FR Doc. 2018–01705 Filed 1–29–18; 8:45 am] a live webcast for those unable to attend clinical trials (available on FDA’s
BILLING CODE 4184–01–P the meeting in person (see Streaming guidance web page at https://
Webcast of the Public Meeting). www.fda.gov/downloads/

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Document Created: 2018-10-26 10:13:10
Document Modified: 2018-10-26 10:13:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public meeting.
Dates		The public meeting will be held on April 16, 2018, from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Contact		Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993, 301-796- 2500, [email protected]
FR Citation		83 FR 4210

83 FR 4210 - Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 20 (January 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration