Recently FDA has taken initiative encouraging the use of real world data (RWD) for regulatory submissions. High quality RWD may be sufficient for use in premarket and postmarket regulatory decisions, without changing the standards used to make those decisions. This brings in new opportunities and challenges in terms of a new innovative and cost effective approach to design clinical trials and observational studies.
I am proposing to organise a dedicated symposium on the usages and advantage of using large primary and ambulatory care based patient-level RWD to conduct clinical studies including late phase studies. The proposed symposium will include presentation on (1) international scenario in the use of real world primary / ambulatory care data to generate much needed population level evidences; (2) the context and 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. We can have a dedicated talk from 2 presenters with opportunities for interactive discussions.
For about a decade now, I have been leading pharmaco-epidemiological studies in diabetes with large patient level RWD from UK and USA, in corroboration with international academic and pharma collaborators.