• The sponsor must have an Investigational New Drug (IND) or pre-IND number for the medical product in the CID proposal.
• The proposed CID is intended to provide substantial evidence of effectiveness to support regulatory approval of the medical product.
• The trial is not a first-in-human study, and there is sufficient clinical information to inform the proposed CID.
• The sponsor and FDA are able to reach agreement on the trial design information to be publicly disclosed.

FDA welcomes submissions related to any eligible CID. However, given that FDA expects to grant up to two meeting requests per quarter as part of the pilot program, FDA will select requests based on:

• Innovative features of the trial design, particularly whether the innovation may provide advantages over alternative approaches. Initial priority will be given to trial designs for which (1) analytically derived properties (e.g., type I error) may not be feasible and (2) simulations are necessary to determine operating characteristics.
• Therapeutic need (i.e., therapies being developed for use in disease areas where there are no or limited treatments).

Sponsors may request to participate in the program on a rolling basis through June 30, 2022. Only those requests received by the last day of each quarter of the fiscal year will be considered for the following quarter. Proceeding to disclosure discussions notifications and meeting denied decisions will be made within 45 days after the quarterly closing date.

Meeting requests should be submitted electronically to the relevant application (i.e., pre-IND, IND) with “CID Pilot Program Meeting Request for CDER” (CDER applications) or “CID Pilot Program Meeting Request for CBER” (CBER applications) in the subject line. Please review the information about providing regulatory submissions in electronic format.

In addition, please send an email to [email protected] providing notification your CID meeting request has been submitted to the relevant application.

Include the following information in the meeting request (25 pages or fewer):

1. Product name.
2. Application number.
3. Proposed indication(s) or context of product development.
4. Background section that includes a brief history of the development program and the status of product development.
5. Trial objectives.
6. Brief rationale for the choice of the proposed CID.
7. Description of study design, including study schema with treatment arms, randomization strategy, and endpoints.
8. Key features of the statistical analysis plan, including, but not limited to, the analyses, models, analysis population, approach to handling missing data, and decision criteria. These key features should include aspects of the design that may be modified and the corresponding rules for decisions, if adaptive.
9. Simulation plan, including the set of parameter configurations that will be used for the scenarios to be simulated and preliminary evaluation and discussion of design operating characteristics. Preliminary simulation results of the operating characteristics (e.g., type I error, power) should include several plausible hypothetical scenarios.
10. Elements of the study design that the sponsor considers nondisclosable, along with a rationale for exclusion.
11. A list of issues for discussion with FDA about the specific CID proposed approach for the applicable drug development program and a summarized list of next steps in the regulatory decision-making process along with any supporting data relevant to the discussion.

Within 45 days after the quarterly closing date, FDA will review the meeting requests, select up to four meeting requests each quarter (two primary and two alternates) to proceed to disclosure discussions, and notify sponsors of their status. Before FDA grants the initial meeting under the CID pilot meeting program, FDA and the sponsor must discuss and agree on the information that FDA may include in public case studies. The specific information to be disclosed will depend on the content of each meeting request and associated CID. FDA intends to focus on information that is beneficial to advancing the use of CIDs, and those elements relevant to the understanding of the CID and its potential use in a clinical trial intended to support regulatory approval. FDA intends to include the following categories regarding the proposed CID in a disclosure agreement with sponsors before they can be accepted into the pilot program.

Disclosure Categories:

1. Rationale for the selected design
2. Study design characteristics:
   1. Randomization
   2. Blinding
   3. Study schema
   4. Study endpoints
   5. Target population
   6. Sample size determination, including assumptions
   7. Choice of controls (external/historical, concurrent)
   8. Estimand(s) of interest
   9. Adaptive elements, including aspects of the design that can be modified
3. Analysis plan:
   1. Model(s), including underlying assumptions and any prior distributions
   2. Null and alternative hypotheses
   3. Statistical test(s)
   4. Approaches to handle missing data and multiplicity
   5. Decision criteria throughout the trial, including rules for adaptive decisions
4. Simulations:
   1. Objectives and assumptions
   2. Scenarios, including parameter configurations and the rationale for parameter values considered, and hypothetical examples of trials for a given simulation scenario
   3. Simulation results, including operating characteristics such as Type I error probability, power, expected sample size/duration, and estimation properties
5. Data access plan components and any other approaches to minimize impacts on trial integrity imposed by the innovative design  
6. Any modifications or amendments to any of the above that occur during interactions about the proposed CID between Submitter and FDA

Sponsors whose meeting requests are granted as part of the pilot program should submit a meeting information package electronically no later than 30 days before the initial meeting and no later than 90 days before the follow-up meeting. Include “CID Pilot Program Meeting Package for CDER” (CDER applications) or “CID Pilot Program Meeting Package for CBER” (CBER applications) in the subject line.

The initial meeting package should include the following information:

1. Product name.
2. Application number.
3. Proposed agenda, including estimated times needed for discussion of each agenda item.
4. List of questions for discussion, along with a brief summary of each question that explains the need or context for the question.
5. Detailed description of the statistical methodology, including, but not limited to, the analyses, models, analysis population, approach to handling missing data, and decision criteria.
6. Detailed simulation report that includes the following:
   1. Example trials in which a small number of hypothetical trials are described with different conclusions.
   2. Description of the set of parameter configurations used for the simulation scenarios, including a justification of the adequacy of the choices.
   3. Simulation results detailing the simulated type I error probability and power under various scenarios.
   4. Simulation code that is readable, is adequately commented on, and includes the random seeds. The code should be written in widely used programming languages such as R or SAS to facilitate the simulation review.
7. Overall conclusions, including a brief summary of the simulated operating characteristics based on design features and analyses and a discussion of the utility of the CID given the simulation results.

The follow-up meeting package should include the following information:

1. Product name.
2. Application number.
3. Updated background section that includes a brief history of the development program and the status of product development and clinical data to date, if applicable.
4. Proposed agenda, including estimated times needed for discussion of each agenda item.
5. List of questions for discussion with a brief summary of each question that explains the need or context for the question.
6. Updated programs/shells for simulations, if applicable.
7. Summary of new information that is available to support discussions.

A meeting summary will be sent to the requester within 60 days of each meeting.

For more information regarding a submission inquiry to CDER please use the subject line:
“CID Pilot Meeting Program for CDER”