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Streamlined mail-based methods for large randomised trials: lessons learnt from the ASCEND study (published online 30/11/2019)

Streamlined mail-based methods for large randomised trials: lessons learnt from the ASCEND study (published online 30/11/2019)

Marion M. Mafham, Louise J. Bowman, Richard J. Haynes, Jane M. Armitage

Randomised trials have become so costly and complex to conduct that many important research questions go unanswered. Novel streamlined methodologies, including the use of registry trials, have been proposed. In this issue, Mafham et al (https://doi.org/10.1007/s00125-019-05049-8) outline the lessons learned from A Study of Cardiovascular Events iN Diabetes (ASCEND), a large mail-based trial of aspirin and of n-3 fatty acid supplementation for the primary prevention of serious vascular events in people with diabetes. The authors describe how this trial obtained reliable randomised evidence at a fraction of the cost of traditional clinic-based trials, and how insights from its design and conduct will inform future studies. They also consider the limitations of the study and how these could be circumvented in future studies. The authors conclude that similar approaches should be adopted by other researchers in order to answer important clinical questions that are relevant to improving health.

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