HAR674: Randomised Controlled Trials


Introduction

Randomised Controlled Trials (RCTs) are used to test the effectiveness of interventions. This module covers the appropriate use of trials, the range of trial designs, strategies to optimise recruitment, sample size, outcome measures, the use of economic and qualitative methods alongside trials, the role of clinical trials units, ethical issues and governance procedures.

Objectives

This unit aims to give students a detailed knowledge of key aspects of randomised controlled trials.

Learning outcomes

By the end of the unit, students will be able to:

  • Differentiate across the range of trial designs, evaluating their appropriate use;
  • Critically evaluate the key elements of trial design and analysis;
  • Design and plan a clinical trial within procedures and guidelines.

Teaching Methods

Teaching is lecture based.  Group exercises based around examples from real trials will develop students’ critical understanding of trial design.  Independent study will deepen the understanding of design and analysis of trials.

Assessment

Component Weighting
Assignment 100%

The module will be assessed through one assignment at the end of the module. This assignment will consist of one question, which will test the knowledge and understanding of aspects of the range of trial designs, design and analysis of trials and procedures for undertaking trials. Students are expected to make reference to the methodological literature in their answers.

Students are expected to draw on what they have learnt within the module and to reference the recommended papers and books when these are relevant to their answers. Students are encouraged to read outside recommended texts and are welcome to bring this learning into their assignments. We highly recommend that students pay attention to addressing the questions asked.

The pass mark is 50%.