Real-World Evidence Studies in the post-COVID-19 Era: Methodological Considerations for Pandemic Related Disruptions

Background: The COVID-19 pandemic has generated enormous morbidity and mortality, as well as massive health system disruptions that include changes in use of prescription medications, outpatient encounters, emergency department admissions, and hospitalizations. These pandemic-related disruptions are reflected in real-world data (RWD) derived from electronic medical records, administrative claims, disease/medication registries, and mobile devices and, thus, have methodological implications for COVID-19 as well as non-COVID-19 research. Researchers and policy makers seeking to perform real-world studies and interpret real-world evidence (RWE) will need to consider how the pandemic may exacerbate perennial challenges inherent to non-experimental research that utilizes RWD encompassing pandemic time periods. These concerns may be particularly amplified in studies of historically marginalized populations that have been differentially impacted by COVID-19. Researchers interested in modern study design and analytic approaches to mitigate epidemiological biases exacerbated by the pandemic can attend to interact with experts seeking to facilitate high-quality uses of RWD.

Objectives: The workshop will be conducted in an interactive format using motivating study examples and will focus on the following objectives:
· To illustrate the impact of COVID-19 on patterns of healthcare utilization as well as the content and quality of data collected within RWD sources
· To highlight potential consequences that the pandemic may have on study design elements of non-experimental studies
· To discuss the implications of pandemic-related disruptions on possible threats to external and internal validity
· To propose a framework guidance developed by an ISPE RWE Taskforce subteam to mitigate potential biases exacerbated by the pandemic

Description: The workshop will include a short introduction and overview, a point-counterpoint interactive methods session with use cases, and a panel discussion encouraging active audience participation.

A. Introductions (5 min, Anne Mobley Butler)

B. Overview of recent global epidemiology data to discuss shifts in treatment seeking behavior, healthcare delivery, and impact on short-term/long-term outcomes and RWD quality (15 min, G. Caleb Alexander)

C. Point-Counterpoint interactive methods session to address COVID-19 pandemic-induced threats to external and internal validity, using motivating study examples. (50 min, Mehmet Burcu, Anne Mobley Butler, Helga Gardarsdottir)

D. Interactive panel discussion with the audience on a framework for the design and analysis of non-experimental studies that use data from the COVID-19 era. (20 min, moderator: Mehmet Burcu)