Statistical Analysis Plan (SAP) – ACTA – Australian Clinical Trials Alliance

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

Other Resources:

JAMA Guidelines for Statistical Analysis Plans

Statistical Analysis Plan Template

Type of resource: doc Type of resource: pdf

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.

DOC PDF

Protocols and SAPs for Adaptive Trials

Type of resource: URL

A repository of protocols and SAPs for adaptive trials.

VISIT WEBSITE

Examples of SAPs:

Other Resources:

Resource Documents

Statistical Analysis Plan Template

Protocols and SAPs for Adaptive Trials

Latest Resource

Webinar recording: APT Virtual Clinic – the PANTHER trial

STInG Chat – How to build a career as a clinical trials biostatistician

Webinar recording: APT Virtual Clinic – SEISMIC and IVCare

Webinar recording: APT Virtual Clinic – ED Asthma and CAPTIVATE

Webinar recording: Historical and non-concurrent controls in clinical trials

ACTA Consumer Remimbursement and Remuneration Policy

STInG Chat – ‘Securing Funding: Tips and Tricks for Investigator Grants’

Webinar recording: APT Virtual Clinic – ACT-GLOBAL Adaptive Platform Trial for Stroke

Workshop: How to better develop cross-network collaborations and linkages

Webinar recording: APT Virtual Clinic – UNSW / Black Dog Institute on Treatment-Resistant Depression

Webinar recording: Introduction to Git for Clinical Statisticians

The processes involved in a Data and Safety Monitoring Board/Committee with special reference to the role of the various statisticians

ACTA 2022-2023 Annual Report

ACTA Whistleblower Policy

ACTA STInG grant advice for trial statisticians

Webinar recording: APT Virtual Clinic – PLATIPUS: A Platform for Adaptive Trials in Perinatal Units

ACTA STInGChat – ‘Climbing the Career Cascade’

Webinar recording: APT Virtual Clinic – Schizophrenia Platform for Improving Recovery with Integrated Trials

Seamless Phase 2_3 Trials in Oncology

Adaptive Design Clinical Trials

Career paths for academic biostatisticians

HEAT webinar recording: Design of economic evaluations along the development process

Workshops and Virtual Clinics on Adaptive Platform Trials

Webinar recording: APT Virtual Clinic – the BAT and PASSPORT Trials

Exploring greater partnership between Clinical Trial Networks, Clinical Quality Registries and Trial Coordinating Centres with Industry

HEAT Webinar Recording-Flexible survival models and why we (might) need them

HEAT Webinar Recording- Use of Administrative Data for Measuring Events and Healthcare Use

ACTA STInG: N-of-1 Trials Webinar Series – Webinar 2

Recommendations to improve cultural and linguistic diversity in clinical trials

ACTA STInG: N-of-1 Trials Webinar Series – Webinar 1

Adaptive Platform Trial Summaries

Approaches to prioritising researchfor clinical trial networks: a scoping review

HEAT Webinar Recording- Economic Evaluation Alongside Adaptive Trials

ACTA 2021-2022 Annual Report

Effective strategies to manage data integrity risks webinar

The Data Lifecycle: Ethical use of data webinar

Approaches to prioritising research
for clinical trial networks: a scoping review