John Scott, Dieter Häring, Marius Thomas, Olivier Collignon
PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Complex Innovative Designs (CID) in practice. Speakers from regulatory authorities and industry will present on their experience.
The following aspects are covered:
• Overview of the FDA Complex Innovative Trial Design pilot program and the applications received to date together with details on some of them
• Overview of the FDA guidance on interacting on Complex Innovative Trial Designs
• Detailed case study of a clinical trial in children which was evaluated within FDA’s CID pilot program, applying borrowing of information from external trials in adults
• Overview of statistical and regulatory considerations on master protocols, focusing on Phase III confirmatory trials