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# Stakeholders Back Meeting Pilot Program
- URL: https://www.fdaweb.com/stakeholders-back-meeting-pilot-program/
- Published: 2018-10-04T12:00:00.000Z
- Updated: 2026-09-15T00:35:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142520

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA complex innovative trial design (CID) pilot meeting program “should help to promote the regulatory acceptance of and agreement on CIDs that support regulatory decision-making across review divisions.” In a comment [letter](https://www.regulations.gov/document?D=FDA-2018-N-0049-0014&ref=fdaweb.com), the association recommends that the agency establish a pilot selection process that includes the biostatistics pilot leadership team as well as the individual review divisions, particularly the signatory authority within the divisions, to ensure alignment and agreement of CID approaches. PhRMA also provided recommendations on several issues that it says would provide greater clarity to pilot participants and facilitate a better understanding and utilization of CID approaches in drug development.

The Biotechnology Innovation Organization (BIO) [said](https://www.regulations.gov/document?D=FDA-2018-N-0049-0011&ref=fdaweb.com) it supports the pilot’s goal to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. “BIO believes that the work CDER and CBER are doing to better understand and utilize complex innovative trial designs is of great importance to patients and sponsors alike,” the comment says.