SW-1A - Building transparency and reproducibility into the practice of pharmacoepidemiology and outcomes research

Background: Real-world evidence (RWE) studies are increasingly used to inform regulatory, policy, and clinical decisions. However, there remain concerns about the credibility and reproducibility of RWE studies. While there is universal agreement on the critical importance of transparent and reproducible science, the building blocks of open science practice that are common across many disciplines have not yet been built into routine workflows for pharmacoepidemiology and outcomes research. As the impact of RWE on healthcare practice and policy continues to expand, it is clear that a key focus area in the coming years must be to embed transparency and reproducibility as a core element of routine research conduct.
Whereas clinical trial registration and data sharing underwent a major transformation at the beginning of the century, a future in which RWE is recognized as consistently reliable and fit-for-decision-making requires a fundamental paradigm shift in how we think about and realize transparency and reproducibility in practice.

Objectives: 1. Highlight transparency and reproducibility challenges in RWE and concrete solutions and frameworks to address them
2. Illustrate practical opportunities to implement open science principles with examples
3. Offer a platform for discussion with multiple stakeholder perspectives
4. Call to action

Description: Dr. Anton Pottegård will introduce the top 10 must-reads for transparency (10 min). Dr. Shirley Wang will summarize why change is needed and recent developments for pharmacoepidemiologists in terms of transparency and reproducibility (REPEAT, HARPER, HMA-EMA Catalogues, large distributed data networks, clinical code list and programming code sharing, 20 min). Dr. Pottegård will illustrate how open science principles can be incorporated into your work with contemporary examples (15 min). Dr. Patrice Verpillat will provide a regulatory perspective (10 min). Dr. Joshua Gagne will provide an industry perspective (10 min). The session will conclude by engaging the audience in discussion of the role of ISPE and an action plan to advance transparency for pharmacoepidemiology (25 min).