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

202261 citationsJournal Articlehybrid Open Access

Authors

Victoria Homer · Cancer Research UK Clinical Trials Unit

Christina Yap

Simon Bond · MRC Clinical Trials Unit at UCL

Jane Holmes · Nuffield Orthopaedic Centre

Deborah Stocken · University of Leeds

Katrina Walker · University of Leeds

Emily Robinson · Royal Marsden NHS Foundation Trust

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 & Keywords

Statistical Methods in Clinical Trials Meta-analysis and systematic reviews Health Systems, Economic Evaluations, Quality of Life

Publication Details

Published in: BMJ

Volume 376, pp. e068177-e068177

DOI: 10.1136/bmj-2021-068177

Field-Weighted Citation Impact: 13.55

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

Authors

Abstract

Topics & Keywords

Publication Details