As part of good clinical practice, ACTA recommends that every academic clinical trial should have a detailed pre-specified analysis plan that is publicly available.
This page provides guidance for how to develop a detailed statistical analysis plan for a clinical trial. It includes a template, developed by the ACTA Statisticians Interest Group (STInG) as well as examples of previous statistical analysis plans.
Examples of SAPs:
- SAVE trial, 2017 winner of the ACTA STInG Excellence in Trial Statistics Award
- N3RO trial, 2018 winner of the ACTA STInG Excellence in Trial Statistics Award
- ADRENAL, 2019 winner of the ACTA STInG Excellence in Trial Statistics Award
- ENZAMET, 2020 winner of the ACTA STiNG Excellence in Trial Stastics Award
- PEPTIC, 2021 winner of the ACTA STInG Excellence in Trial Stastics Award
- PADDI, 2022 winner of the ACTA STInG Excellence in Trial Stastics Award
- ASCOT, 2023 winer of the ACTA STInG Excellence in Trial Stastics Award
- BRACE, 2024 winner of the ACTA STInG Excellence in Trial Stastics Award
Other Resources:
Resource Documents
Statistical Analysis Plan Template
This document provides a template for statistical analysis plans and will enable the user to develop a detailed and structured plan pre-specifying the analysis of a clinical trial.
Protocols and SAPs for Adaptive Trials
A repository of protocols and SAPs for adaptive trials.
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