Analyses of Clinical Trials, Interpretation and Communication of Trial Findings

Course Type
Postgraduate, Continuing professional development, Module

Analyses of Clinical Trials, Interpretation and Communication of Trial Findings

This is a core module on the MSc/PGDip in Clinical Trials programme. It is available as an optional module on the PGCert when taken alongside the following modules. Either:

  • Rationale for Clinical Trials, Key Concepts and Features
  • Selection, Collection and Reporting of Trial Outcomes
  • Early Phase Clinical Trials

Or:

  • Rationale for Clinical Trials, Key Concepts and Features
  • Design and Delivery of Further Clinical Trials

It can also be taken on a stand-alone basis.

Module Overview
This module focusses on the final stages of a trial, after patients have been recruited and treated and outcome data collected.  The module provides an overview of how statistical methods are used to reach conclusions from a trial’s data, drawing examples from a variety of clinical areas, types of data and analysis methods. The focus is on understanding the principles and correct interpretation of analyses, and appropriate presentation of results, rather than the implementation of statistical methods.  A range of problems arising in the analysis of trials will be covered, including missing data, non-compliance and interaction effects, and the impact of such problems on the interpretation of results will be considered.  The module will also focus on problems in the interpretation of traditional trials, and some potential solutions.  The process of publication and dissemination of trial results will be examined, and the longer-term use of trial findings, including incorporation of trials into meta-analyses and systematic reviews, health economic analyses, and use in clinical guidelines and decisions about service provision, by bodies such as NICE. Throughout the module concepts will be illustrated with real trials, and a major theme will be critical evaluation of published trials.  There will be a mix of lectures, facilitated small group discussions, and assignments.

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: 

  • Explain the rationale and main features of methods of statistical analysis used in parallel randomised controlled trials
  • Recognise the need for health economic evaluations within trials and interpret the main findings of such evaluations
  • Identify common problems that arise in the analysis of trials and propose appropriate solutions to minimise bias
  • Critically evaluate the design and analysis of published trials and interpret the results of statistical analyses to reach justified conclusions
  • Explain the principles of trial reporting and justify why certain features need to be reported; effectively present trial data, results and conclusions through oral and written communication
  • Describe how trials’ results are used to inform guidelines for clinical practice and decisions about service provision


Module Attendance Required
2 block week of teaching

Module Dates
2019/20

10-14 February 2020
24-28 February 2020

Assessment

  1. 2000-word extended writing (60%)
  2. Exhibition/poster display (20%)
  3. 1500-word critical appraisal (20%)


Academics involved in the delivery of this module
Professor Simon Gates
Peter Fletcher

Stand Alone Course 

Fee
£1028

Entry requirements

  • An interest in evidence-based practice
  • 2:1 honours degree (or equivalent) in a health or life sciences related subject (for example, medicine, pharmacy, nursing, psychology, health sciences), medical statistics or health economics
  • Individuals not meeting the above requirement who have equivalent relevant work experience will be considered on an individual basis.

To apply please contact the programme team at clinicaltrialsmsc@contacts.bham.ac.uk