FDA’s New Center for Clinical Trial Innovation: Would it Help the Sponsors?
(Thursday, April 18, 2024) Since the publication of the Critical Path Initiative over two decades ago which included smart trial designs, the FDA has introduced several innovative clinical trial designs to improve clinical trial conduct and expedite new drug developments. However, the adoption of those non-conventional designs has not yet become mainstream. Most clinical trials still follow traditional designs due to a combination of two factors: sponsors taking a risk-averse approach to use traditional trial designs that can clear FDA review faster, and FDA reviewers providing sponsors limited support with innovative trial designs owing to mixed experiences with such trial designs. The FDA has created a new center to address that. Clinical trials are an essential and the most expensive component of new drug development since laws were passed in the 1960s requiring all new drugs to demonstrate safety and effectiveness before commercial release. Most clinical trial rules have evolved over the last 60 years focusing on ethical conduct while generating credible clinical data. The last two decades were devoted to smart clinical trial designs that could maximize the outcome of clinical trials by using smart trial designs such as adaptive clinical trials, master protocols, pragmatic trial design, Phase 0 trials, decentralized trial designs, patient-focused drug development, and others. These new trial designs have been adopted by the industry to various extents. While adaptive clinical trial designs are used by more than 20% of all clinical trials (based on a high-level review of trials posted on clinicaltrials.gov), other designs have found niche acceptance. The newly created CDER Center for Clinical Trial Innovation or C3TI aims to increase the use of smart trial designs by increasing internal training of FDA’s reviewers on the FDA’s centralized knowledge repository of smart clinical trial designs, sharing FDA’s experience with innovative trial designs with sponsors via seminars, workshops, conferences, and publications, and creating new knowledge via Demonstration Programs where FDA reviewers will work select sponsors on new trial designs to share their mutual experience with everyone. The formation of C3TI acknowledges that the FDA needs to work internally as much as externally to encourage the adoption of new trial designs. C3TI will centralize the support system both for FDA’s reviewers who would cross-train on various trial designs and the sponsors of trials who would get to learn from the FDA’s knowledge repository and be able to seek specialized support for new trial designs via C3TI. Currently, C3TI will focus on the trial designs that have been previously introduced by the FDA such as pragmatic trials and Bayesian analysis. In the future, as it collects more knowledge across the CDER, C3TI will likely propose new designs of its own. C3TI is envisioned as a support/facilitation center both for FDA’s reviewers and sponsors. Decisions about the appropriateness of the trial design will still be made by the respective review divisions. Also, it is not expected to expedite the review of clinical protocols by the FDA, but will likely play a role in convincing the FDA reviewers about accepting new trial designs, if needed, as it will participate in FDA-sponsor meetings and discussions. The final decision about the applicability of the outcome of the trials, designed with this partnership, on FDA decisions, resides with the review centers, as well. Sponsors should explore involving C3TI early on, as early as the pre-IND meetings, to discuss their trial designs with the FDA. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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