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August 28, 2019Pilot and Feasibility Studies137 citationsOpen Access

Should treatment effects be estimated in pilot and feasibility studies?

JSJulius Sim

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Abstract

Treatment effects calculated from pilot or feasibility studies should not be the basis of a sample size calculation for a main trial, as the MID to be detected should be based primarily on clinical judgement rather than statistics. Deciding on progression to a main trial based on these treatment effects is also misguided, as they will normally be imprecise, and may be biased if the pilot or feasibility study is unrepresentative of the main trial.

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Julius Sim (2019) studied this question.

synapsesocial.com/papers/69dd5d6d0644c7b49d40d367https://doi.org/10.1186/s40814-019-0493-7
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