Скачать с ютуб Enhancing Adoption of Innovative Clinical Trial Approaches - Day 2 в хорошем качестве

Enhancing Adoption of Innovative Clinical Trial Approaches - Day 2

To keep pace with the ever-changing drug development landscape, the U.S. Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) is working extensively to advance innovation in clinical trial design and conduct. CDER’s portfolio of clinical trial innovation includes guidance documents, working groups, public workshops, public-private partnerships, and other programs dedicated to enhancing the design and conduct of clinical trials. While there is increasing momentum to transform clinical trials, many opportunities still exist to improve implementation and adoption of innovations in clinical trial approaches. The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, convened a two-day hybrid public workshop on March 19 & 20 to explore these opportunities and shared strategies for sustainable improvement of clinical studies. The goals of this workshop were to identify key insights to clinical trial modernization efforts around the following topics: Adoption within existing regulatory and compliance guidelines Incorporation of patient experiences for improving participation Evaluation of existing technology, infrastructure, and organizational culture for participation in research Collaborations among regulatory agencies and across industries to facilitate innovation