Before proceeding with trials that use complex innovative designs (CID), sponsors should meet with the FDA to discuss their plans, according to a final guidance released Wednesday that provides details on the kinds of information to bring to an agency meeting.

Because novel trial designs often use untried methods, such as computer simulations and other new technical approaches, the FDA would like to discuss with sponsors the purpose, execution and operating characteristics of their trials, as well as plans for data analysis and presentation.

Although the agency provides no definition of CID beyond “trial designs that have rarely or never been used,” it offers some examples, including master protocols, Bayesian analysis and sequential multiple assignment randomized trials.

Sponsors should provide the agency with detailed documentation of their plans, including how the choice of trial design fits into the sponsor’s overall drug development program, plans for possible adaptations or interim analyses and a detailed evaluation of the design’s chance of producing erroneous conclusions.

Sponsors can request a meeting through the normal pathways, such as pre-IND and end-of-phase 2 meetings.

The guidance was first introduced as a draft in September 2019. No public comments on the draft were submitted.

Read the guidance here: https://bit.ly/3nBLDl5.