Notice2023-25854
Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice; Public Workshop; Request for Comments
Primary source
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Published
November 22, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 The workshop may also inform a draft guidance on the use of Bayesian methodology in clinical trials of drugs and biological products.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.
Full Text
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<title>Federal Register, Volume 88 Issue 224 (Wednesday, November 22, 2023)</title>
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[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Pages 81422-81423]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#4c0f0508620129293825222b3f0c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="0b48424f25466e6e7f62656c784b6d6f6a25636378256c647d">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>.
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 (<a href="https://www.fda.gov/drugs/development-resources/complex-innovative-trial-design-meeting-program">https://www.fda.gov/drugs/development-resources/complex-innovative-trial-design-meeting-program</a>).
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 <a href="https://www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024">https://www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024</a>
prior to the workshop.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit
<a href="https://ComplexInnovativeDesignsWorkshop.eventbrite.com">https://ComplexInnovativeDesignsWorkshop.eventbrite.com</a> 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 <a href="https://ComplexInnovativeDesignsWorkshop.eventbrite.com">https://ComplexInnovativeDesignsWorkshop.eventbrite.com</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024">https://www.fda.gov/news-events/advancing-use-complex-innovative-designs-clinical-trials-pilot-practice-03052024</a>.
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
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