FDA piloting innovative clinical trial designs

The US Food and Drug Administration announced a novel clinical trial design to be used in clinical development programmes. 

The design has been called the complex innovative trial design (CID) and highlights the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI). This was signed into law last year as part of the FDA Reauthorisation Act.

The CID programmes include seamless trial designs, Bayesian methods, complex adaptive designs, using biomarker enriched populations and other risk-benefit determinations.

Regular meetings will run until September 2022, and are intended to ‘stimulate and inform individual product development programs’ and to propose innovative trial designs to inform regulations.

The FDA has previously provided guidance on expanding the use of first-in-human (FIH) clinical trials, aiming to push the development of cancer drugs.

Meetings under this programme will be conducted by the FDA’s Centre for Drug Evaluation and Research (CDER) or the Centre for Biologics Evaluation and Research (CBER). In order to promote innovation in the design of clinical trials, those developed through this pilot programme may be presented by the FDA as guidance to others or a public workshop. 

The FDA is also providing early meeting discussions on how a proposed CID approach can be used in specific drug development programmes, and is also accepting up to two meeting requests per quarter each year for those sponsors who reach an agreement with the FDA.

The FDA look to accept requests based on innovative features of the trial design and therapeutic need. The innovative features of the trial should provide clear advantages over alternative methods, with analytically derived properties.

Meeting requests should be submitted electronically to the relevant application, with more information available here.