Many clinical trials of new healthcare interventions, especially those required to meet the requirements of regulatory authorities, are ‘explanatory’ in nature. This means that they are executed to strict protocols including tight inclusion and exclusion criteria, tightly controlled delivery of the intervention and comparator as well as any concomitant therapy, measures in place to ensure string adherence to the intervention, intensive follow-up data and a pre-specified analysis plan. The underlying purpose is that the trial should have the best chance of identifying differences in efficacy or safety. However there is increasing concern that effectiveness in ‘real world’ situations (routine practice) differs from that predicted from efficacy reported such trials. This has led to increased interest in more ‘pragmatic’ trials, where many of the strict protocol elements are relaxed, and results may be more immediately generalisable to routine practice.


How to cite: Pragmatic Trials [online]. (2016). York; York Health Economics Consortium; 2016.


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