Early phase clinical trials extension to guidelines for the content of statistical analysis plans

Victoria Homer, Christina Yap, Simon Bond, Jane Holmes, Deborah Stocken, Katrina Walker, Emily J Robinson, Graham Wheeler, Sarah Brown, Samantha Hinsley, Matthew Schipper, Christopher J Weir, Khadija Rantell, Thomas Prior, Ly-Mee Yu, John Kirkpatrick, Alun Bedding, Carrol Gamble, Piers Gaunt

This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders.