2021 FDA Science Forum – Session #1- Improving Clinical and Post-Market Evaluation

This area of research notably exercises the use of real-world evidence (RWE), complex innovative trial design (CID), modeling informed product development, product safety surveillance and digital health. Data that comprise RWE include electronic health records, administrative claims, and patient-reported data via mobile devices. CID includes complex adaptive, Bayesian, and other trial designs that are used selectively to provide substantial evidence of effectiveness in new drug applications or biologics license applications. A common feature of many CIDs is the need for simulations rather than mathematical formulae to estimate trial operating characteristics. Model-informed drug development is an approach that involves developing and applying exposure-based, biological and statistical models derived from preclinical and clinical data sources to inform drug development and decision-making. Product safety surveillance includes the use of FAERS and VAERS. Digital health includes mobile health, health information technology, wearable devices, telehealth and telemedicine, and digital personalized medicine.