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This module will introduce the main issues in the design, analysis and interpretation of clinical trials.

Intended learning outcomes

Upon successful completion of the module, a student will be able to:

• Explain fundamental principles of comparative clinical trials in investigating and ensuring efficacy and safety of treatments.
• Describe the main features of clinical trials, including methodological and organisational considerations.
• Explore key decisions surrounding design, delivery and assessment of clinical trials.
• Explain the principles of trial conduct, reporting and meta-analyses.

Session Content

The module is expected to cover the following topics:

• General principles of comparative clinical trials.
• Randomisation (including the rationale, organisation, ethics and methods of randomisation).
• Size of trials (including power calculations, the need for large trials, and problems of small trials).
• Data monitoring.
• Clinical trials reporting.
• Alternative trial designs.
• Drafting a trial protocol.
• Principles of meta-analysis.

Mode of delivery

This module is delivered predominantly face-to-face. Where specific teaching methods (lectures, seminars, discussion groups) are noted in this module specification, these will be delivered by predominantly face-to-face sessions. There will be a combination of live and interactive activities (synchronous learning) as well as self-directed study (asynchronous learning).

Assessment

Assessment for this module will be in the form of a written assignment. The written assignment will contain short answer questions. Students will be asked to consider various trial scenarios in relation to the topics covered on the course, for example: trial size; randomisation; data monitoring; reporting of results and interpretation; multiplicity and subgroup analyses; and alternative trial designs.

Credits

• CATS: 10
• ECTS: 5

Module specification

For full information regarding this module please see the module specification.

Please note: information based on the 2024-25 module specification subject to change for 2025-26 entry.