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Designing trials to generate evidence for “real life” - on the trade-offs between pragmatic and explanatory trials

Department of Molecular Medicine presents
Designing trials to  generate evidence for  “real life” - on the trade-offs between pragmatic and explanatory trials

Date: September 7th, 2022  Time:14:00-16:00 GMT


Clinical trials can be placed on a spectrum between explanatory and pragmatic designs. The talk will introduce this concept and the PRECIS-2 tool to understand how different design aspects of a trial relate to it. We will discuss how neither trial type is superior to the other but instead how they help to answer different questions. Although pragmatic trial designs have arguably become the accepted standard for generating evidence directly applicable to routine care, their design may at times rely on fragile assumptions and their results may be difficult to interpret. In the talk, we will use some of our own current trials and observational studies as case studies. In this context, we will explore how different pragmatic or explanatory design elements may introduce bias. We will further reflect on how this concern can be met by careful selection of secondary trial endpoints or by nested qualitative studies.
The talk will introduce background and basic principles and proceed to considerations for application and may thus be suitable for a diverse audience from advanced undergraduate students to senior researchers.