USA – FDA finalizes guidance on complex innovative trials designs

The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID) for drugs and biologics.
 
The nine-page final guidance comes just over a year after the draft version was released for comment and two years after the agency launched its CID pilot program. (RELATED: FDA launches pilot program in support of complex trial designs for drugs and biologicsRegulatory Focus 29 August 2018).
 
The aim of the CID program is to facilitate the use of novel and innovative trials, including complex adaptive and Bayesian designs that often feature simulation. FDA explains that “there is no fixed definition of CID because what is considered innovative or novel can change over time,” and that the guidance is intended to apply to trail designs “that have rarely or never been used to date to provide substantial evidence of effectiveness” in new drug applications (NDAs) or biologics license applications (BLAs).
 
While FDA’s CID pilot program is set to run through September 2022, the agency explains that sponsors may present and discuss CID proposals through existing pathways for interaction, though the pilot program offers sponsors the opportunity for additional meetings with FDA review staff and senior decision-makers…