Notice2024-07829
Center for Drug Evaluation and Research Center for Clinical Trial Innovation
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 16, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI aims to be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making. C3TI's mission is to promote existing and future CDER clinical trial innovation activities through enhanced communication and collaboration. Existing CDER clinical development innovation programs will continue to operate according to their established processes with C3TI serving to synthesize lessons learned across those programs. C3TI will also be providing additional opportunities for sponsors of innovative clinical trials in the project areas described below to interact with CDER staff with the goal of fostering knowledge sharing both internally and externally.
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<title>Federal Register, Volume 89 Issue 74 (Tuesday, April 16, 2024)</title>
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[Federal Register Volume 89, Number 74 (Tuesday, April 16, 2024)]
[Notices]
[Pages 26897-26898]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07829]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1336]
Center for Drug Evaluation and Research Center for Clinical Trial
Innovation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing this
notice to announce the establishment of the Center for Drug Evaluation
and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI
aims to be a central hub within CDER that supports innovative
approaches to clinical trials that are designed to improve the quality
and efficiency of drug development and regulatory decision making.
C3TI's mission is to promote existing and future CDER clinical trial
innovation activities through enhanced communication and collaboration.
Existing CDER clinical development innovation programs will continue to
operate according to their established processes with C3TI serving to
synthesize lessons learned across those programs. C3TI will also be
providing additional opportunities for sponsors of innovative clinical
trials in the project areas described below to interact with CDER staff
with the goal of fostering knowledge sharing both internally and
externally.
DATES: The applicable date of this notice is April 15, 2024.
FOR FURTHER INFORMATION CONTACT: Kevin Bugin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-2302, <a href="/cdn-cgi/l/email-protection#aae1cfdcc3c484e8dfcdc3c4eacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="b8f3ddced1d696facddfd1d6f8dedcd996d0d0cb96dfd7ce">[email protected]</span></a> or
<a href="/cdn-cgi/l/email-protection#82c1c6c7d0c1eeebecebe1e3eed6f0ebe3eecbececedf4e3f6ebedecc2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="8ecdcacbdccde2e7e0e7edefe2dafce7efe2c7e0e0e1f8effae7e1e0cee8eaefa0e6e6fda0e9e1f8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
CDER guides and fosters drug development by providing scientific
and regulatory advice and direction. Evolving understanding of disease
biology and molecular pharmacology, advancements in drug discovery, and
growth in novel therapeutics have the potential to transform the
development of promising new therapies. These changes in the drug
development landscape can be further facilitated by novel clinical
trial designs, innovative strategies for trial execution, and the
expanding range of drug development tools. Similarly, later stages of
development, including in the postmarketing setting, can benefit from
innovative approaches to study design and analysis. These innovative
approaches can include adoption of new statistical approaches,
incorporation of pragmatic trial elements, the implementation of point-
of-care trials, and wider adoption of selective safety data collection.
With this changing landscape in mind, CDER has many ongoing efforts
to advance innovation in clinical trial design and conduct. These CDER
efforts have led to improvements in more efficiently designing and
conducting
[[Page 26898]]
clinical trials that are intended to generate evidence of safety and
effectiveness of therapies that in turn showcase the value of clinical
trial innovations. CDER leads or co-leads several ongoing programs to
advance innovation, and CDER recognizes that additional innovative
areas would benefit from the enhanced interactions that are the staple
of these programs.
CDER also recognizes that opportunities exist to further enhance
the adoption of clinical trial innovations, including the amplification
of lessons learned across CDER's robust clinical innovation programs.
On October 17, 2023, CDER solicited public comments on the barriers and
facilitators to incorporating successful or promising innovative
clinical trial approaches in drug development programs. These public
comments were discussed as part of a public workshop led by the Duke-
Margolis Institute for Health Policy, under a cooperative agreement
with FDA, on March 19 and 20, 2024. Topics addressed during the
workshop included, but were not limited to, those listed below:
<bullet> Evolution of clinical research and the current state of trial
innovation
<bullet> Regulatory and compliance considerations
<bullet> Patient-centric and recruitment considerations
<bullet> Infrastructure and organizational considerations
<bullet> Global regulatory collaboration on clinical trial innovation
<bullet> Collaborations across industry, academia, and FDA to leverage
innovation
<bullet> Future directions on clinical trial innovation
As a result of these discussions and internal deliberation, FDA is
establishing C3TI to further enhance clinical trial innovation for drug
development and regulatory decision making. C3TI will serve as a
central hub to (1) facilitate the sharing of lessons learned across
CDER's existing clinical trial innovation programs, (2) communicate and
collaborate with external parties about innovative clinical trials, and
(3) manage a C3TI Demonstration Program that will expand opportunities
for sponsors of innovative clinical trials in the areas described below
that are under a pre-investigational new drug application (pre-IND) or
IND to interact with CDER staff.
II. Goals of C3TI
Specifically, C3TI aims to:
<bullet> Assist stakeholders involved in clinical research in staying
current with clinical trial innovations
<bullet> Improve the efficiency and effectiveness of clinical trials
<bullet> Help increase the participation of diverse populations in
clinical trials
<bullet> Enhance the quality of clinical trial data
<bullet> Accelerate the development of safe and effective new drugs
<bullet> Serve as a central hub for knowledge management and
coordinating lessons learned across CDER's clinical trial innovation
programs
<bullet> Establish a C3TI Demonstration Program that will include case
examples from ongoing development programs in the project areas
described below to spur innovation across therapeutic areas
III. Activities of C3TI
C3TI provides a single CDER location to engage stakeholders and
assist with non-product-specific questions on innovative clinical trial
approaches. C3TI maintains a website at <a href="http://fda.gov/C3TI">fda.gov/C3TI</a> to centralize
information on existing and new CDER clinical trial innovation efforts,
including links to existing websites and resources. C3TI can be
contacted at <a href="/cdn-cgi/l/email-protection#82c1c6c7d0c1eeebecebe1e3eed6f0ebe3eecbececedf4e3f6ebedecc2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="d59691908796b9bcbbbcb6b4b981a7bcb4b99cbbbbbaa3b4a1bcbabb95b3b1b4fbbdbda6fbb2baa3">[email protected]</span></a>. Additionally,
C3TI will coordinate and act as a liaison to facilitate information
sharing with external stakeholders, as appropriate and permitted by
law, when they engage CDER on general clinical trial innovation
matters. It will also support knowledge sharing internally through
various mechanisms, such as discussion forums and communications, and a
centralized knowledge repository. This repository will curate knowledge
about completed CDER clinical trial innovation activities and maintain
a comprehensive portfolio of ongoing efforts and knowledge resources.
A critical component of C3TI is expanding the subject areas that
could benefit from enhanced communication between CDER and sponsors and
serve as case examples to spur further innovation. Therefore, C3TI will
manage a demonstration program that includes three initial subject
matter/project areas described below. The program is for selected
sponsors of innovative clinical trials in certain initial project areas
under a pre-IND or IND with CDER that are intended to support new drug
product approvals or changes to approved drug product labeling and that
will serve as case examples that can be shared both internally and
externally to foster innovation across therapeutic areas. If selected,
sponsors will have the opportunity for enhanced communication and
interaction with CDER staff. Because the goal of selecting these case
examples from clinical trials under a pre-IND or IND is to ultimately
share lessons learned more broadly with the clinical trial community,
participating sponsors and FDA will agree on aspects of the development
program that FDA can disclose even before a drug is approved.
The three initial project areas under the C3TI Demonstration
Program are (1) point-of-care or pragmatic trials, (2) Bayesian
analyses, and (3) trials using selective safety data collection. More
information about the C3TI Demonstration Program, including how to
participate and how the program differs from existing clinical trial
innovation programs, is available on the C3TI website: <a href="http://fda.gov/C3TI">fda.gov/C3TI</a>.
IV. Paperwork Reduction Act of 1995
For the C3TI Demonstration Program, FDA will request information
from no more than nine sponsors. Initial statements of interest from
sponsors interested in being evaluated for participation in the C3TI
Demonstration Program are not ``information'' in accordance with 5 CFR
1320.3(h)(1). Thus, this notice contains no new collection of
information.
This notice also refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 312 have been approved under OMB control number 0910-0014. The
collections of information relating to formal meetings between sponsors
or applicants and FDA has been approved under OMB control number 0910-
0001.
Dated: April 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07829 Filed 4-15-24; 8:45 am]
BILLING CODE 4164-01-P
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