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A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. By far the most common approach is to specify a target difference and then estimate the corresponding sample size; this sample size is chosen to provide reassurance that the trial will have high statistical power to detect such a difference between the randomised groups (at the planned statistical significance level). Despite the critical role of the target difference for the primary outcome in the design of a randomised controlled trial (RCT), the manner in which it is determine has received little attention. There is a need for better guidance for researchers and funders regarding specification and reporting of this aspect of trial design. This talk will provide an overview of the new guidance produced as part of the DELTA2 project which is aiming to address this gap. Feedback from session attendees will be invited.
Please provide feedback on the guidance document we will be presenting via survey https://oxford.onlinesurveys.ac.uk/delta2-guidance-jsm
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