PURPOSE:

The GetReal Institute, an independent not-for-profit member organisation, has constituted a working group to explore the need and design of a multi-stakeholder shared learning forum for real world evidence (RWE) as part of a broader test and learn environment in Europe.

The purpose of the workshop is to share an outline of the shared learning forum based on stakeholder discussions, and to elicit feedback from the various and diverse experts in ISPOR attendance that will refine and specify an action plan for such a forum.

DESCRIPTION:

Medicine and vaccine developers have uncertainties about investing in RWE generation approaches in the absence of clarity on decision-maker acceptance and precedent. Decision-makers have uncertainties about Real World Data (RWD) quality and RWE study designs and methods and need more experience to gain and provide the clarity requested by industry. These concerns feed a “vicious cycle” in which stakeholders perceive risk in investing in and relying on RWE.

In this situation, collaborative “test and learn” approaches, methodically and iteratively undertaken, can help to break the logjam. By proposing, conducting, and assessing RWE studies and then communicating and incorporating learnings from the experience, research sponsors and decision-makers can reduce uncertainties about using RWE to better understand medicine and vaccine effectiveness, safety, and value.

In this workshop, Shahid Hanif will present findings from stakeholder engagement (10 min), Bettina Ryll will highlight the importance of the patient voice (5 min), Niklas Hedberg will discuss the value to HTA bodies (5 min), and Anja Schiel will outline the regulatory concerns (5 min). The discussion leaders will conduct a real-time polling of the audience on key issues and conclude with an audience discussion to inform the development of a multi-stakeholder shared learning forum.