2018-01643. Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting.

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, [e-mail].

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/​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, [e-mail], 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.