> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Drug Complex Innovative Designs Pilot Program
- URL: https://www.fdaweb.com/drug-complex-innovative-designs-pilot-program/
- Published: 2018-08-09T12:00:00.000Z
- Updated: 2026-09-15T00:24:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142071

FDA has outlined its planned “Complex Innovative Designs (CID) Pilot Meeting Program” that is intended to advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. Mandated in the latest user fee agreement, the program offers sponsors an opportunity to meet with CDER/CBER staff to discuss their use of CID approaches in clinical trials. “To promote innovation in this area, trial designs developed through the pilot meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for drugs that have not yet been approved by FDA,” an [agency notice](https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm611885.htm?ref=fdaweb.com) says. Under the pilot program, the agency will accept two primary meeting requests and two alternatives per quarter. The notice provides a discussion on eligibility criteria, submission process and the content and format of a meeting request.