C3TI Demonstration Program
CDER Center for Clinical Trial Innovation (C3TI)
Overview
The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides the opportunity to test, implement, and scale the integration of innovation into clinical trials through increased communication and interaction between CDER and sponsors of innovative clinical trials in certain project areas.
The program is for selected sponsors of innovative clinical trials in certain initial project areas under a pre-investigational new drug application (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.
Sharing Lessons Learned
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. Generally, sponsors participating in demonstration projects will be expected to share select details of their clinical trials and the implementation of clinical trial innovations as they progress. This sharing may include updates, lessons learned, and relevant insights gathered during the course of the trial. It is understood that these shared details will reflect general principles and innovative aspects, while maintaining the necessary confidentiality of proprietary or sensitive information.
Initial Demonstration Project Areas
C3TI selected three initial demonstration project areas, which were prioritized given their alignment with the broader objectives of C3TI, their expected readiness of implementation and scalability, and the opportunity to improve lessons learned. C3TI intends to launch additional demonstration project areas as the C3TI Demonstration Program evolves.
The initial project areas are: 1) Bayesian Supplementary Analysis; 2) Selective Safety Data Collection; and 3) Streamlined Trials Embedded in clinical Practice.
More information about each of the demonstration project areas, including the eligibility criteria, is available below. The C3TI Demonstration Program will accept up to nine proposals on a rolling basis within a 12-month period. Instructions on how to submit a proposal can be found on the C3TI Demonstration Program Proposal Submission webpage.
C3TI aims to increase experience in Bayesian statistical methods in simple trial settings across sponsors, CDER clinical reviewers, and CDER statisticians, including deepening an understanding of their applicability, opportunities, and challenges. With this demonstration project, C3TI will partner with sponsors to use Bayesian methods in supplementary analyses during their trial, providing an opportunity for both CDER and sponsors to learn new methods without impacting review criteria.
More information about Bayesian Supplemental Analysis (BSA) Demonstration Project
Selective Safety Data Collection (SSDC) offers an innovative approach to facilitate the conduct of large-scale efficacy and safety trials through the purposeful reduction in the collection of certain types of data for drugs or biologics with a well-characterized safety profile. C3TI aims to promote the adoption of SSDC principles into appropriate drug development programs. This demonstration project aims to partner with sponsors to strategically streamline data collection in some late-stage pre-approval or post-approval trials, creating benefits such as reducing the burden of collecting unnecessary safety data, eliminating unnecessary expense and allocating resources to the relevant objectives of a study, and facilitating trial conduct to answer important scientific questions on long-term efficacy and safety of drugs and biologics.
More information about Selective Safety Data Collection (SSDC) Demonstration Project
C3TI aims to promote the adoption of pragmatic design elements to integrate randomized trials into clinical practice and improve coordination and collaboration between CDER and sponsors to effectively support these innovative trials. To this point, CDER will partner with sponsors on trials that include limited procedures outside of routine clinical care, decentralization of procedures that can be done outside of designated research sites, the use of real-world data to obtain outcomes, and, where appropriate, the integration into point-of-care practice. These types of trials are advantageous as they can be more resource-efficient, able to better attract broader study populations, can be completed more rapidly, and yet still robustly assess study objectives.
More information about Streamlined Trials Embedded in clinical Practice (STEP) Demonstration Project
Connect with us
CDERclinicaltrialinnovation@fda.hhs.gov