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 Robinson, Graham Wheeler, Sarah Brown, Samantha Hinsley, Matthew J. Schipper, Christopher J. Weir, Khadija Rantell, Thomas J. Prior, Ly‐Mee Yu, John Kirkpatrick, Alun Bedding, Carrol Gamble, Piers Gaunt
Abstract
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.
Topics & Concepts
Computer scienceContent analysisStatistical analysisClinical trialExtension (predicate logic)Phase (matter)Data scienceInformation retrievalMedicineStatisticsPathologyMathematicsSocial scienceOrganic chemistryChemistrySociologyProgramming languageStatistical Methods in Clinical TrialsMeta-analysis and systematic reviewsHealth Systems, Economic Evaluations, Quality of Life