Randomised Controlled Trial Design

This document provides an overview of the design aspects, types, strengths & limitations, and applicable methods for randomised clinical trials.

Knowledge Resource
Oct 18, 2023

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Randomised Controlled Trial Design Knowledge Resource


A randomised controlled trial (RCT) is a type of scientific study—often considered the gold standard in clinical research—that aims to reduce bias when testing a new treatment. The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard or placebo treatment as the control. Randomisation minimises selection bias and the different comparison groups allow the researchers to determine any effects of the treatment when compared with the no treatment (control) group, while other variables are kept constant.


This document summarises key design aspects for randomised clinical trials (RCTs), a cornerstone of evidence-based medicine. The document begins with a definition of RCTs and an overview of fundamental characteristics. Next, it explores different types of RCTs, strengths and limitations, and applicable methods for different stages of design, conduct, analysis, and reporting.


1. Definition

2. Purpose

3. Types of Case-Control Studies

4. Strengths & Limitations

5. Methods

6. Sources

Important notice: The information contained in this document has been compiled with the greatest care. However, the authors shall have no liability for inaccuracies, nor for damages of any kind arising out of the use, reference to or reliance on the contents of this document, even if advised of the possibility of damages arising.
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