Hosted by the Department of Epidemiology
Presented by
Shirley Wang, PhD
Associate Professor, Brigham and Women’s Hospital, Harvard Medical School
There is increasing interest in real-world evidence (RWE) generated from routinely collected healthcare data to inform clinical and regulatory decision-making. However, the literature is littered with poor quality studies and conflicting results. Transparent, reproducible, and methodologically sound research is critically important to generate credible and actionable insights to improve public health.
This talk will highlight key initiatives advancing methodological rigor in RWE generation, including RCT-DUPLICATE, a large-scale effort that benchmarked >30 RWE studies against reference randomized controlled trials; the REPEAT Initiative, which empirically assessed the transparency and reproducibility of 150 published RWE studies; and HARPER, a harmonized protocol template designed to enhance the reproducibility of RWE studies that has been endorsed by key global stakeholders.
Together, these projects demonstrate how systematic replication, open science practices, and fit-for-purpose design, data, and analytic frameworks can strengthen confidence in evidence from studies that make use of routinely collected healthcare data. Attendees will gain practical insights into approaches that enhance the reliability, transparency, and credibility of real-world evidence used to inform clinical and public health decision-making.
Shirley Wang, PhD, is an Associate Professor at Brigham and Women’s Hospital, Harvard Medical School. Her research is focused on 1) developing innovative, non-traditional analytic methods to understand the safety and effectiveness of medication use in routine clinical care as well as 2) facilitating appropriate use of complex methods for analyzing large observational healthcare data. She leads the Meta-Research in Pharmacoepidemiology program, with recent projects aimed at improving the transparency, reproducibility and robustness of evidence from healthcare databases (REPEAT Initiative), and informing when and how real-world evidence studies can draw causal conclusions to inform regulatory or other healthcare decision-making (RCT-DUPLICATE), through a series of large scale emulation projects offering insights into what types of clinical questions can be answered with real-world data and which methods are the most robust.
In-Person at 708 Broadway, Room 801 and online via Zoom. In-person attendance is restricted to members of the NYU community.