Rationale for Clinical Trials, Key Concepts and Features

Course Type
Postgraduate, Continuing professional development, Module

Rationale for Clinical Trials, Key Concepts and Features

This is a core module on the MSc/PGDip in Clinical Trials programme

Module Overview

This module will provide students with a thorough understanding of why clinical trials have become so important in the evaluation of healthcare, social care and public health interventions. Whilst providing an overview of the different phases of clinical trials, the module will focus on the fundamental features of definitive randomised controlled trials.  Key decisions surrounding the design of trials, such as methods of randomisation, blinding and sample size, will be explored. The module will also introduce key statistical concepts applicable to the design, analysis and interpretation of trials. By the end of the module students will be equipped with the knowledge and skills to recognise when a clinical trial is needed and contribute to the design of a subsequent trial.

Method of Teaching

The module involves a variety of teaching methods, including lectures, seminars, tutorials, practical classes/workshops and guided independent study. 

Learning Outcomes

By the end of the module you should be able to: 

  • Distinguish between observational and interventional study designs and identify the most appropriate design for different research questions.
  • Explain the fundamental principles of randomised controlled trials and propose methods to reduce bias in the design of trials.
  • Summarize the factors that have driven the development of Good Clinical Practice (GCP) guidelines and regulatory requirements in trials.
  • Construct appropriate research questions with consideration of population, intervention, control and outcomes.
  • Demonstrate that systematic reviews are essential for contextualising trials and recognise the essential processes involved in undertaking a systematic review.
  • Critically appraise medical research literature, including systematic reviews, relevant to a particular area of healthcare, social care and public health research.
  • Explain key statistical concepts such as probability and statistical inference and interpret measures of treatment effect, confidence intervals and P-values.
  • Discuss the need for sample size calculations and the impact of changing trial assumptions on the required size of a trial.

Module Attendance Required

2 block weeks of teaching

Module Dates

Module dates to be confirmed


  1. A 2.5-hour unseen examination (80%)
  2. A 1500-word critical appraisal (20%)

Academics involved in the delivery of this module

Lee Middleton
Dr Jon Bishop