[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Pages 81422-81423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4965]


Advancing the Use of Complex Innovative Designs in Clinical 
Trials: From Pilot to Practice; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the following public workshop entitled ``Advancing the Use 
of Complex Innovative Designs in Clinical Trials: From Pilot to 
Practice.'' The purpose of the public workshop is to discuss aspects of 
complex adaptive, Bayesian, and other novel clinical trial designs. 
This workshop is being conducted to meet the performance goal of 
convening a public workshop on complex innovative design (CID) included 
in the seventh authorization of the Prescription Drug User Fee Act 
(PDUFA VII). The workshop may also inform a draft guidance on the use 
of Bayesian methodology in clinical trials of drugs and biological 
products. In conjunction with the workshop, FDA is seeking comments on 
the use of CID to inform regulatory decision making, including high-
level case examples of CIDs and approaches that can advance the use of 
these designs. The public workshop will be held on March 5, 2024, from 
9 a.m. to 3:30 p.m. Eastern Time.

DATES: Either electronic or written comments on this public workshop 
must be submitted by April 5, 2024. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room, Silver Spring, MD 20993-0002. Entrance for the public workshop 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/about-fda/visitor-information. The public workshop will use an online platform for the 
webcast.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of April 5, 2024. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-4965 for ``Advancing the Use of Complex Innovative Designs 
in Clinical Trials: From Pilot to Practice; Public Workshop; Request 
for Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management 
Staff. If you do not wish your name and contact information to be made 
publicly available, you can provide this information on the cover sheet 
and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Tuan Pham, Food and Drug 
Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 3670, Silver Spring, MD 20993-0002, 301-
348-1595, [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 81423]]

I. Background

    This public workshop is intended to meet a performance goal FDA 
agreed to under the FDA User Fee Reauthorization Act of 2022, in 
accordance with the PDUFA Reauthorization Performance Goals and 
Procedures Fiscal Years 2023 Through 2027 letter (PDUFA VII letter), 
which is available at https://www.fda.gov/media/151712/download. 
Specifically, section I.4.e of the PDUFA VII letter outlines goals to 
enhance FDA's capacity to review complex innovative designs and convene 
a public workshop to discuss aspects of complex adaptive, Bayesian, and 
other novel clinical trial designs.

II. Topics for Discussion at the Public Workshop

    The purpose of this public workshop is to facilitate discussion on 
the use of external data sources, Bayesian statistical methods, and 
simulations in complex innovative trial designs as well as trial 
implementation (e.g., examples of defining and mitigating bias when 
using select trial design methods). Discussion topics will include 
considerations for external data sources, Bayesian statistical methods, 
simulations, and clinical trial implementation and will be based on FDA 
accumulated experience both within and outside of the Complex 
Innovative Trial Design Meeting Program (https://www.fda.gov/drugs/development-resources/complex-innovative-trial-design-meeting-program).
    The workshop will consist of two sessions. The first session will 
focus on case studies that will illustrate various aspects of complex 
innovative designs and implementation. The second session will consist 
of panel discussions motivated by the case studies. There will be an 
opportunity for public comment.
    Workshop updates, agenda, and background materials (if any) will be 
made available at https://www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024 
prior to the workshop.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit 
https://ComplexInnovativeDesignsWorkshop.eventbrite.com by February 
27, 2024, 11:59 p.m. Eastern Time. Registration will be available 
starting January 16, 2024. Please provide complete contact information 
for each attendee, including name, affiliation, and email. If you are 
unable to attend the workshop in person, you can register to view a 
live webcast of the workshop. You will be asked to indicate in your 
registration if you plan to attend in person or via the webcast.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by February 27, 2024, 11:59 p.m. Eastern Time. 
Early registration is recommended because onsite seating is limited; 
therefore, FDA may limit the number of in-person participants from each 
organization. Registrants will receive a confirmation email after they 
register.
    If you need special accommodations due to a disability, please 
contact Tuan Pham (see FOR FURTHER INFORMATION CONTACT) at least 14 
days before the workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be available on webcast. To register for the webcast of this 
public workshop, visit https://ComplexInnovativeDesignsWorkshop.eventbrite.com by February 27, 2024, 11:59 p.m. Eastern Time. Please 
provide complete contact information for each attendee, including name, 
affiliation, and email. A link to the webcast will be provided 
following registration. Although FDA verified the website addresses in 
this document, please note that websites are subject to change over 
time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. A link to the transcript will also be available on 
the internet at https://www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024.

    Dated: November 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25854 Filed 11-21-23; 8:45 am]
BILLING CODE 4164-01-P