Module Catalogue

MCR8008 : Clinical Trials

  • Offered for Year: 2017/18
  • Module Leader(s): Prof. Elaine McColl
  • Lecturer: Dr Ruben Thanacoody, Dr Lynne Corner, Dr Thomas Chadwick, Dr Alison Steel, Dr Alastair Greystoke
  • Teaching Location: Newcastle City Campus
Semester 2 Credit Value: 20
ECTS Credits: 10.0


This module is part of the Clinical Research Programme and is designed to expand upon principles of the design, conduct and analysis of clinical trials. Students will be introduced to the principles and practices of the design and conduct of trials of both pharmaceutical and complex interventions, assessing the efficacy, effectiveness and cost-effectiveness of the trialled interventions.

The focus is on the design and conduct of trials of the efficacy, effectiveness and cost-effectiveness of a range of interventions, including pharmaceutical, surgical and complex interventions. Practical aspects of trial design and conduct, including ‘marketing’ the trial, consumer involvement and engagement with clinical research networks, will also be considered. The module is designed to equip students with the skills required to critically appraise all aspects of trials designed by others and to design and implement their own trials.

Outline Of Syllabus

The drug development process, from bench to bedside
Phase I to Phase IV drug trials, their purpose and design
The role of NICE and other bodies in bringing drugs and technologies into routine clinical practice
Explanatory vs. pragmatic trials
The nature and role of feasibility and pilot studies
Patient preference trials
Recruitment and retention strategies for trials
'Marketing' clinical trials
Ethical issues in clinical trials
Different trial designs (parallel group, cross-over, factorial designs, equivalence trials, non-inferiority trials etc) – their advantages and disadvantages
Statistical considerations in clinical trials (including sample size calculations)
Economic evaluation alongside trials, including economic modelling
Patient reported outcomes, their choice and application
The MRC framework for complex interventions
Consumer involvement in clinical and health-related research
Costing a research study
The role of clinical research networks in supporting trials and other high quality clinical research

Teaching Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Scheduled Learning And Teaching ActivitiesLecture181:0018:0019 lectures of varying length.
Guided Independent StudyAssessment preparation and completion601:0060:00N/A
Guided Independent StudyDirected research and reading501:0050:00N/A
Guided Independent StudyReflective learning activity201:0020:00N/A
Guided Independent StudyIndependent study521:0052:00N/A
Teaching Rationale And Relationship

Face-to-face contact in this module will take the form of lectures. Self-guided learning, in the form of preparatory and post-session reading for lectures, and preparation of the written assessments.

Assessment Methods

The format of resits will be determined by the Board of Examiners

Other Assessment
Description Semester When Set Percentage Comment
Written exercise2M60Critical Review and Selection of Patient Reported Outcome Measure(s) for a Specific Study (max 2000 words).
Written exercise2M40Review of Funding Proposal for a Clinical Trial (max 2000 words).
Assessment Rationale And Relationship

In the first written assignment, students will be presented with a specific study scenario and will be asked to identify and review candidate measures of patient reported outcomes, and to make a recommendation as to which measure(s) would be the most suitable for use in the specific study scenario.

The second written assignment is in the form of a structured review (using the funding body’s peer review form) of a funding proposal for a clinical trial. This will require students to integrate their learning across this module including practical skills regarding drug trials and complex interventions and involvement of consumers and key stakeholders in research as well as key aspects of health economics (and indeed to draw on learning from other modules), and to comment on the scientific and practical aspects of the proposed study.

Written communication, planning and organisation and information literacy are practiced and assessed in the critical review and selection of patient reported outcome measures and in the review of a funding proposal for a clinical trial. Interpersonal communication is practiced and assessed in a written format in both assessments. Clear communication is crucial in both of these written pieces. Computer skills are practiced through the use of MS Word and for accessing pertinent information for the two reviews for assessment. Adaptability, initiative, some numeracy and problem solving are practiced int he module and may be critical in the production of these two reviews also.

Reading Lists