Notice2021-16709
Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design; Public Workshop
Primary source
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Published
August 5, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design." The purpose of the public workshop is to discuss applications of complex and innovative trial designs in pediatric clinical trials.
Full Text
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<title>Federal Register, Volume 86 Issue 148 (Thursday, August 5, 2021)</title>
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[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Page 42849]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16709]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0771]
Advancing the Development of Pediatric Therapeutics Complex
Innovative Trial Design; Public Workshop
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Advancing the Development of
Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.'' The
purpose of the public workshop is to discuss applications of complex
and innovative trial designs in pediatric clinical trials.
DATES: The public workshop will be held virtually on September 1, 2021
(Day 1), from 10 a.m. to 3 p.m. Eastern Time and September 2, 2021 (Day
2), from 10 a.m. to 3 p.m. Eastern Time. See the SUPPLEMENTARY
INFORMATION section for registration information.
ADDRESSES: The public workshop will be held in virtual format only.
Please note that due to the impact of this COVID-19 pandemic, all
meeting participants will be joining this public meeting via an online
teleconferencing platform and will not be held at a specific location.
FOR FURTHER INFORMATION CONTACT: Evangela Covert, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5234, Silver Spring, MD 20993, 301-796-
4075, <a href="/cdn-cgi/l/email-protection#aaefdccbc4cdcfc6cb84e9c5dccfd8deeacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="c287b4a3aca5a7aea3ec81adb4a7b0b682a4a6a3ecaaaab1eca5adb4">[email protected]</span></a>; or Denise Pica-Branco, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6402, Silver Spring, MD 20993, 301-796-
4075, <a href="/cdn-cgi/l/email-protection#eeaa8b80879d8bc0be878d8f8c9c8f808d81ae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="266243484f554308764f454744544748454966404247084e4e5508414950">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Over the last two decades, great advances have been made in
pediatric drug development. In addition, there is a growing recognition
that complex and innovative trial designs have the potential to
optimize drug development in small populations. Innovations that have
been proposed include Bayesian and other methods of utilizing external
historical information from previous pediatric trials or other
populations (such as adults), adaptive designs, bridging biomarkers,
etc. These designs tend to require more extensive discussion and
collaboration between drug developers and regulators to implement
effectively.
The Complex Innovative Trial Design Pilot Meeting Program (CID
Program) facilitates and advances the use of these types of designs by
providing for increased interactions between staff in the Center for
Drug Evaluation and Research and the Center for Biologics Evaluation
and Research and sponsors accepted into the program. Several pediatric
study designs have been accepted into the CID Program. This workshop is
being organized in collaboration with the CID Program.
II. Topics for Discussion at the Public Workshop
The main objective of the ``Advancing the Development of Pediatric
Therapeutics (ADEPT 7) Complex Innovative Trial Design'' workshop is to
discuss opportunities for leveraging complex and innovative trial
designs, understand the challenges with their applications, and develop
solutions on how challenges in the designs can be overcome. The
workshop will specifically focus on two topics of interest: Bridging
biomarkers in pediatric extrapolation and Bayesian techniques in
pediatric studies. In addition, the workshop will allow for an open
dialogue around the use of these approaches among regulators, industry,
academia, and patient organizations.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://go.umd.edu/ADEPT7">https://go.umd.edu/ADEPT7</a>. 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. Early registration is recommended because
space is limited; therefore, FDA may limit the number of participants
from each organization.
If you need special accommodations due to a disability, please
contact
Evangela Covert or Denise Pica-Branco (see FOR FURTHER INFORMATION
CONTACT) no later than August 18, 2021, by 5 p.m. Eastern Time.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at the following site: <a href="https://collaboration.fda.gov/adept7">https://collaboration.fda.gov/adept7</a>.
If you have never attended a Connect Pro event before, test your
connection at <a href="https://collaboration.fda.gov/common/help/en/support/meeting_test.htm">https://collaboration.fda.gov/common/help/en/support/meeting_test.htm</a>. To get a quick overview of the Connect Pro program,
visit <a href="https://www.adobe.com/go/connectpro_overview">https://www.adobe.com/go/connectpro_overview</a>. 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.
Dated: August 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-16709 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P
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