[Federal Register Volume 89, Number 74 (Tuesday, April 16, 2024)]
[Notices]
[Pages 26897-26898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [email protected] or 
[email protected].

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:

 Evolution of clinical research and the current state of trial 
innovation
 Regulatory and compliance considerations
 Patient-centric and recruitment considerations
 Infrastructure and organizational considerations
 Global regulatory collaboration on clinical trial innovation
 Collaborations across industry, academia, and FDA to leverage 
innovation
 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:

 Assist stakeholders involved in clinical research in staying 
current with clinical trial innovations
 Improve the efficiency and effectiveness of clinical trials
 Help increase the participation of diverse populations in 
clinical trials
 Enhance the quality of clinical trial data
 Accelerate the development of safe and effective new drugs
 Serve as a central hub for knowledge management and 
coordinating lessons learned across CDER's clinical trial innovation 
programs
 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 fda.gov/C3TI to centralize 
information on existing and new CDER clinical trial innovation efforts, 
including links to existing websites and resources. C3TI can be 
contacted at [email protected]. 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: fda.gov/C3TI.

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