Module 4 Design of Clinical Trials

This MSc Clinical Research 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.

Principal module aims

This module enables students to:

  • Evaluate key concepts in the design of clinical trials.

  • Consider the most frequently utilized study designs.

  • Be aware of key concerns in clinical trial management (data, people resources, safety, regulatory).

Learning outcomes

  • Critically evaluate the key concepts, structures and procedures of clinical trial management.

  • Explain the phases of clinical trials and contrast the characteristics of a randomized controlled trial (RCT) to other types of clinical trial designs.

  • Discuss the appropriateness of a trial design to answer a specific research question.

  • Critically evaluate key issues in patient and public involvement in clinical trials.

  • Appraise the challenges of involving special populations (children, elderly, adults lacking capacity etc) in clinical trials.

  • Develop appropriate techniques for attracting and retaining trial participants.

  • Calculate the resource required for development and management of clinical trials as required by regulatory agencies.

  • Evaluate methods to maximise compliance with treatment, follow-up and safety monitoring within a clinical trial.

Teaching Topics

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

  • Introduction and ethics in clinical trials.

  • Study protocol and trial designs

  • Methodological considerations for clinical trials

  • Study populations and cohorts.

  • Clinical Trial Design: Phase I-IV designs.

  • Treatment allocations.


Randomised Control Trials – a critical review (100%)

A 4,000-word critical review of two given published randomised control trials. The assessment will require students to consider the ethics, principles, study design and conduct of two clinical trials.