Background: ISPE's new strategic plan has tasks related to supporting real-world evidence (RWE) methods development, enhancing outreach to other scientific disciplines involved in RWE, and emphasizing the prominence of pharmacoepidemiology in this space. Part of this strategic initiative is to form a longer-term task force that takes responsibilities for these goals, and promotes the scientific methods, education, and policies related to the development, use, and interpretation of real-world data and RWE. ISPE sought volunteers from all members and formally created a RWE Task Force at the end of 2019. In this symposium, we will invite ISPE leadership, co-leads of the Task Force, and several sub-groups within the Task Force to share the background, current status, and future directions of ISPE’s effort to strengthen its leadership in the “science of RWE”. This symposium will also be an opportunity to gather input from ISPE members.
Objectives: • To provide an overview of the rationale and objectives of the ISPE RWE Task Force and its 11 sub-groups • To share the progress, current status, future plans, opportunities and challenges of the ISPE RWE Task Force • To discuss how to best coordinate expertise from ISPE members and build collaborations with external stakeholders. • To solicit additional input and engagement from ISPE members on the next steps of the RWE Task Force
Description: • The symposium will start with a short introduction of the panel members and topics and continue with presentations from 5 speakers. The workshop will end with an interactive discussion between the audience and the panelists. Scheduled presentations and speakers are listed below: Outline a. Opening remarks and history of the ISPE RWE Task Force (5 min, Almut Winterstein) b. Overview of the mission, structure, and current plan of the ISPE RWE Task Force (Helga Gardarsdottir, 15 min) c. Showcase #1: Collaboration with ISPOR on ISPOR on RWE reproducibility and transparency (Shirley Wang, 15 min) d. Showcase #2. Strategic plan for RWE manuscript development: who, what, where? (Mehmet Burcu; 15 min) e. Showcase #3. How to engage with external societies and promote ISPE as key resource for RWE methods----Medical Device example (Mary Beth Ritchey, 15 min) f. Panel discussion (25 min, Facilitated by Wei Zhou)