[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4210-4211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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