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Managing Clinical Trials: Putting Science into Practice

Module description

This optional module will take you through the process of designing and undertaking a clinical trial. It will focus on randomised controlled trial design and the practicalities of managing such a trial. It will consider the practicalities from the perspective of the principal investigator: from building the right team, applying for funding, to resourcing the trial, understanding recruitment and randomisation procedures, selecting outcome measures, collecting and managing data, to analysing and reporting findings. 

This module will draw upon the Year Two modules, Principles of Medical Research, Introduction to Health Research and Ethical Issues in Health Research; your experience of planning and undertaking your own research projects and/or of working in project teams whilst on placement. You will have the opportunity to develop your critical appraisal skills for applied health care research. 

Students who have previously taken this module have noted that its useful content is interesting and applicable to multiple disciplines.

Module aims - intentions of the module

This module will provide the information necessary to enable you to understand the key principles that underpin the successful design and implementation of a new clinical trial.

Intended Learning Outcomes (ILOs)

ILO: Module-specific skills

On successfully completing the module you will be able to...

• 1. Demonstrate an integrated understanding of the scientific principles underpinning translational research and putting science into clinical practice.
• 2. Demonstrate an understanding of the key principles that influence new clinical trial design; including but not limited to the role of diagnostic biomarkers, the development of complex behavioural interventions and the role of health prevention.
• 3. Demonstrate an integrated understanding of treatment efficacy principles and key considerations surrounding the use of new technologies when designing clinical trials.
• 4. Understand the expected performance standards in relation to scientific probity and multidisciplinary team-based practice.
• 5. Demonstrate an awareness of key human science principles associated with human health, illness and disease.

ILO: Discipline-specific skills

On successfully completing the module you will be able to...

• 1. Not applicable to this module as it is multi-disciplinary

ILO: Personal and key skills

On successfully completing the module you will be able to...

• 6. Manage time, workload, ambiguity, change and stress effectively.
• 7. Demonstrate professional competence in communicating effectively with patients, healthcare professionals and lay audiences

Syllabus plan

Whilst the module’s precise content may vary from year to year, an example of an overall structure is as follows: 

Clinical Trials - what are they and why do we have them? 

Principles of Research Governance 

Setting up a Clinical Trial:

• Identifying and forming a hypothesis
• Power calculations and statistical considerations
• Designing the study / different trial phases
• Defining inclusion / exclusion criteria
• Randomisation process
• Defining critical outcome measurements
• Writing a protocol, including timeline of the trial

Carrying out a clinical trial:

• Trial management and maintenance
• Patients/participants selection, recruitment and retention
• Importance of accuracy of clinical data
• Data Capture and Storage 

Industry / NHS setting specific issues, e.g. pharmaceutical issues, Patient and Public Involvement (PPI) in research 

Working with Academia and Probity 

Presentation and Dissemination of Results

Learning activities and teaching methods (given in hours of study time)

Details of learning activities and teaching methods

Formative assessment

Summative assessment (% of credit)

Details of summative assessment

Details of re-assessment (where required by referral or deferral)

Re-assessment notes

Please refer to the TQA section on Referral/Deferral: http://as.exeter.ac.uk/academic-policy-standards/tqa-manual/aph/consequenceoffailure/

Indicative learning resources - Basic reading

Friedman et al (eds) Fundamentals of Clinical Trials, 4th edition, 2010, Springer: New York.

Students will be expected to read and critically appraise landmark and original papers in journals such as The New England Journal of Medicine, The Lancet, British Medical Journal and relevant specialist journals.

Indicative learning resources - Web based and electronic resources

Web based and electronic resources will be available

Key words search

Managing Clinical Trials