Response: Officially launched with the publication of a Federal Register Notice in August 2018, the CID Pilot Meeting Program is a U.S. Food and Drug Administration (FDA)-led pilot meeting program which supports the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. Under the sixth iteration of the Prescription Drugs User Fee Amendments (PDUFA VI), FDA agreed to conduct a pilot meeting program for highly innovative trial designs for which analytically derived properties may not be feasible, and simulations are necessary to determine trial operating characteristics (e.g. Type 1 error).
This program offers sponsors who are selected an opportunity for increased engagement with FDA experts from the Center for Drug Evaluation and Research (CDER) and/or Center for Biologics Evaluation and Research (CBER) to discuss CID and analyses in medical product development. The pilot program period will be conducted through September 30, 2022.
The FDA CID Pilot Meeting Program notice in the Federal Register states that for each sponsor whose meeting request is granted, FDA will conduct two meetings to discuss regulatory approaches for the specific CID. How will these two meetings differ and is there a recommended structure?
Response: The FDA envisions an iterative process and will utilize the first meeting to focus on a discussion of the 1) rationale for the proposed design and analysis, 2) statistical analysis plan, and 3) simulations. Sufficient details should be provided in the initial meeting package to allow for a fruitful discussion. The outcome of the initial meeting will be to summarize important discussion points, areas of alignment, clarifications, and action items. The subsequent follow-up meeting will be conducted approximately 120 days after the initial meeting and will focus on new information resulting from incorporation of the initial feedback.
Response: The FDA understands that the specified timelines may prove challenging; however, our expectation is that substantial simulations will have already been conducted prior to the first meeting thus lessening the amount of time needed to generate new information for the second meeting. The FDA will assess the timelines as the program matures and consider changes as needed to maximize the utility of the CID Pilot Meeting Program. Any changes will be disseminated via the CID website.
Response: Sponsors should include a brief summary of the evolution of design options and associated simulations in the meeting package. Such a summary will serve to better inform FDA of options considered by the sponsor.