Introductory description

This module provides students with theoretical and practical perspectives of the design of clinical trials. Students will appraise the ethics and principles underpinning the design of clinical trials for medical and pharmaceutical research.

Module web page

Module aims

Outline syllabus

This is an indicative module outline only to give an indication of the sort of topics that may be covered. Actual sessions held may differ.

The outline syllabus gives an indication of the sort of topics that will be covered in the module.

1. Clinical Trials: Introduction and ethics in clinical trials.
2. Clinical Trials: Phases, contexts, and ethics.
3. Study protocols.
4. Study populations and cohorts.
5. Clinical Trial Design: Phase I-IV designs.
6. Treatment allocations.

Learning outcomes

By the end of the module, students should be able to:

• 1. Critically evaluate the key concepts, structures and procedures of clinical trial management.
• 2. Explain the phases of clinical trials and contrast the characteristics of a randomized controlled trial (RCT) to other types of clinical trial designs.
• 3. Discuss the appropriateness of a trial design to answer a specific research question.
• 4. Critically evaluate key issues in patient and public involvement in clinical trials.
• 5. Appraise the challenges of involving special populations (children, elderly, adults lacking capacity etc) in clinical trials.
• 6. Develop appropriate techniques for attracting and retaining trial participants.
• 7. Calculate the resource required for development and management of clinical trials as required by regulatory agencies.
• 8. Evaluate methods to maximise compliance with treatment, follow-up and safety monitoring within a clinical trial.

Interdisciplinary

Clinical practice necessitates collaboration across disciplines, and it is appropriate that this is reflected in the Masters in Clinical Research. The module is designed to appeal to a range of clinical professionals, including medical, nursing, pharmaceutical, bioscience and other disciplines.

International

The course will recruit from (and be delivered in) multiple territories, and the content will be tailored to the students’ own territories, reflecting local and international standards for clinical research integrity.

Subject specific skills

Subject-specific skills that will be obtained from the module include:

• Understanding of clinical trial design.
• Resource management.
• Development of a research proposal.

Transferable skills

Improvement of a range of transferable skills, including:

• Written communication.
• Organisation and time management.
• Thinking and problem solving.