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July 3, 2014Trials842 citationsOpen Access

Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study

MTM. Dawn TeareNewcastle UniversityMDMunyaradzi DimairoUniversity of SheffieldNSNeil ShephardUniversity of Sheffield

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Abstract

We recommend that an external pilot study has at least 70 measured subjects (35 per group) when estimating the SDp for a continuous outcome. If the event rate in an intervention group needs to be estimated by the pilot then a total of 60 to 100 subjects is required. Hence if the primary outcome is binary a total of at least 120 subjects (60 in each group) may be required in the pilot trial. It is very much more efficient to use a larger pilot study, than to guard against the lack of precision by using inflated estimates.

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Teare et al. (2014) studied this question.

synapsesocial.com/papers/69d77c3aef4aa71f97f3171bhttps://doi.org/10.1186/1745-6215-15-264
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