Event

10:00AM–12:00PM Eastern Daylight Time (EDT)

14:00PM–16:00PM Coordinated Universal Time (UTC)

15:00PM–17:00PM Central European Summer Time (CEST)

While local real-world data is generally preferred by health technology assessment (HTA) agencies, challenges in identifying high quality local data, especially for rare diseases or targeted subpopulations, may turn HTA agencies to consider real-world data (RWD) generated in other jurisdictions. Examples include international data informing estimates of treatment effect heterogeneity for health economic modeling, to identification of prognostic factors used in network meta-analyses and external control arms. Despite this increasing trend, it remains unclear for researchers and decision makers how to systematically evaluate data heterogeneity and transportability of evidence across jurisdictions. Differences between population characteristics, settings, and outcomes, can potentially threaten external validity and limit acceptance.

Although recent real-world evidence (RWE) frameworks have extensively covered considerations for the assessment of fitness of data in RWE studies, there little to no consideration of methodological approaches to guide the transportability of RWE across jurisdictions. The purpose of this course is to provide participants with an understanding of basic concepts around external validity and transportability which become important when international RWE is used in HTA submissions. This will include an overview of steps to first perform a systematic assessment of all important differences between jurisdictions, selecting appropriate methods such as matching and weighting or regression models, and checking of underlying assumptions. The instructors will also discuss specific case studies applicable to HTA and best practices that fit with requirements for objectivity and transparency within existing RWE frameworks. Participants who wish to have access to additional resources are advised to bring their laptops. Handouts will be provided to the audience at the beginning of the course covering all topics covered in the presentations.

PREREQUISITES: Participants are recommended to have at least a basic knowledge of epidemiology and/or biostatistics. No experience with HTA is required.