Recently FDA has taken the initiative encouraging the use of real world data (RWD) for regulatory submissions. This brings in new opportunities and challenges in terms of a new innovative and cost effective approach to design clinical trials and observational studies.
The symposium will discuss the
(1) international scenario in the use of real world primary / ambulatory care data to generate population level evidences;
(2) new opportunities with the FDA initiative of using RWD;
(3) the opportunities and challenges in designing late phase clinical trials and observational studies with RWD; and
(4) the Australian scenario with RWD.
Chairperson: Professor Sanjoy Paul, Melbourne EpiCentre, University of Melbourne