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As medical science continues to advance and new technologies and data sources emerge, the US FDA continues to show interest and support for innovative science and clinical trial designs. The agency has committed to increasing the capacity of their internal teams through various hiring initiatives. In August 2018, they also announced the Complex Innovative Trial Design (CID) Pilot Meeting Program and in the last quarter of 2019, they issued two important documents relating to complex clinical trials:

  • Draft Guidance for Industry: Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products, dated September 2019
  • Guidance for Industry: Adaptive Designs for Clinical Trials of Drugs and Biologics, dated November 2019

In this first of a blog series on CID Trials, we will look at the FDA’s Pilot Meeting Program. In the next part of the series, we’ll discuss the relevant guidance documents.

CID Pilot Program     

In a Federal Register notice on August 29, 2018, FDA announced their Complex Innovative Trial Design (CID) Pilot Meeting Program to facilitate the use of the complex statistical method, Bayesian, and other novel clinical trial designs. The announcement followed FDA public workshops on the use of complex innovative designs (CID) in clinical trials. This program continues through the next two fiscal years, accepting meeting requests through June 30, 2022 and ending on September 30, 2022.

FDA encourages sponsors to seek early interaction with FDA regarding their CID plans. The trial designs accepted into the program will be used as educational resources and participating sponsors will work with FDA on agreement of trial design information that can be publicly disclosed, possibly even before the medicinal product is approved, to help with adoption of CIDs. Participating sponsors have an opportunity to attend two meetings with FDA experts from CDER or CBER to discuss their proposed CID within approximately 120 days. Because some of these trial designs will require complex simulations, the additional time to interact with the agency is expected to benefit sponsors. The agency has committed to accepting up to two meeting requests for the program each quarter.

The agency also outlines the requirements for a meeting request which, among other items, includes a brief rationale for the choice of the proposed CID, a simulation plan, and a list of issues for discussion with FDA about the CID being proposed.

The increasing popularity of CIDs is driven by the growing need for flexible design and analysis approaches in clinical research. Innovative designs that include prospective modifications offer new ways to answer development questions. They also create opportunities for discovery of new therapies for large and small patient populations.

The CID Pilot Meeting Program promotes interactions among agency and sponsor teams, supports innovative science and the use of CIDs, and can potentially lead to new therapeutic options for patients.

The forces of innovation continue to shape clinical research. As sponsors move toward implementing highly complex trial designs and unprecedented methodologies, the need for flexibility and transparency will continue to expand. This new way of working will continue to demand tightly integrated practices, deeper collaboration across stakeholder communities and broader capabilities that have yet to be defined. Traditional clinical research processes will require adjustments, updates, and in some cases, complete rewrites as innovative approaches emerge. Enabling technologies will also have to support new processes, new roles and new requirements for functionality and data access.  It is an exciting time for our industry and for patients who will undoubtedly benefit from these new methods designed to uncover more novel and effective treatments.

The FDA has posted additional information about the CID Meeting Program including overview and process videos, FAQs, and other tools on their Complex Innovative Trial Designs Pilot Program page.

iMednet is a comprehensive, all-in-one platform is uniquely designed to be highly intuitive and flexible, enabling sponsors and CROs to effectively and efficiently meet the demands of adaptive study designs. Contact us to learn more or schedule a demo.