Selection, Collection and Reporting of Trial Outcomes
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:
- Rationale for Clinical Trials, Key Concepts and Features
- Analyses of Clinical Trials, Interpretation and Communication of Trial Findings
- Early Phase Clinical Trials
It can also be taken on a stand-alone basis.
Outcomes assessment is a fundamental aspect of trial design and implementation. Despite this, the rigor with which outcomes are selected, collected and reported in clinical trials is highly variable. Inappropriate selection of outcomes and outcome measures can lead to trial findings of little value to key stakeholders (such as patients) and heterogeneity in outcomes across trials, which makes data synthesis difficult. Issues arising with the collection of outcomes, such as missing data, can impact on the usefulness of a trial’s findings and inappropriate reporting of outcomes can lead to outcome reporting bias and misleading interpretation of a trial’s findings.
This module will consider the various types of outcomes commonly collected in contemporary clinical trials and their key features, strengths and weaknesses. The module will also provide a detailed understanding of the fundamental principles surrounding trial outcome selection, collection and reporting, and will explore solutions to overcoming barriers to successful measurement and appropriate interpretation of different outcomes in a variety of settings. A key aim will be to equip students with the knowledge and critical analysis skills to construct appropriate trial protocol-style written content focused on outcome selection, justification and collection.
Method of Teaching
The module involves a variety of teaching methods, including lectures, seminars, tutorials, practical classes/workshops and guided independent study.
By the end of the module you should be able to:
- Distinguish between types of outcomes commonly collected in contemporary trials and summarize their key features, including modes of collection and impact on the design and conduct of a trial.
- Explain the fundamental principles and key considerations surrounding trial outcome selection, collection and reporting in different settings.
- Identify and support the most appropriate outcome(s) for different research questions.
- Critically appraise trial outcome selection, implementation and reporting/interpretation in medical research literature.
- Appraise existing strategies and, where appropriate, develop new approaches aimed at optimising trial outcome capture in different settings.
- Construct appropriate trial protocol content around outcome selection, justification and collection, relevant to a specific area of research.
Module Attendance Required
1 block week of teaching
- A 2,500-word extended writing (100%)
Academics involved in the delivery of this module
Dr Derek Kyte
Professor Melanie Calvert
Stand Alone Course
- 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 email@example.com