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Randomised Controlled Trials - HEA00159M

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• Department: Health Sciences
• Credit value: 20 credits
• Credit level: M
• Academic year of delivery: 2024-25
  • See module specification for other years: 2023-24

Module summary

This course will enable you to develop an understanding of randomised controlled trial methodology and to develop the practical skills to both design and conduct a randomised controlled trial focussing on evaluation of healthcare interventions, and to critically review existing randomised controlled trials.

Module will run

Occurrence	Teaching period
A	Semester 1 2024-25

Module aims

To understand, critically review and be able to design and conduct a randomised controlled trial focussing on evaluation of healthcare interventions.

Module learning outcomes

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

1. Write a funding proposal for a randomised trial.

2. Critically review published randomised trials.

3. Understand the relationships between sponsor, funder, research ethics, and governance.

4. Design trial documents including patient facing information and data collection tools.

5. Plan and achieve successful participant recruitment and retention within a randomised controlled trial.

6. Have developed skills and knowledge required to deliver a randomised controlled trial.

Module content

• Trial Designs (including Weaknesses of observational Studies, Regression discontinuity; Pragmatic trials. Sources of bias in trials, Cluster design, factorial trials Zelen’s method, Preference, Placebo trial designs, n = 1, cross-over, balanced design)
• Randomisation and protocol design (including Random allocation, sample size, unequal allocation, writing a protocol)
• Recruitment and retention methods
• Design of Patient Materials and Patient and Public Involvement
• Research Approvals
• Data Management
• Additional Trial Evaluations (including Trial cost, Economic evaluation, process evaluations)
• Critical Appraisal of Trials
• Dissemination and Impact

Indicative assessment

Task	% of module mark
Essay/coursework	100

Special assessment rules

None

Indicative reassessment

Task	% of module mark
Essay/coursework	100

Module feedback

Written feedback for the summative assessment is provided on the standard proforma, within the timescale specified in the programme handbook.

Indicative reading

Torgerson, D. and Torgerson, C. (2008). Designing Randomised Trials in Health, Education and the Social Sciences. Basingstoke, UK: Palgrave Macmillan.

UK Trial Managers Network (McDonald A, Farrell B, Booth G, Buckland S, Foster K, Harper L et al, editors). The guide to efficient trial management. Available at: https://www.tmn.ac.uk/resources/34-the-guide-to-efficient-trial-management

ICH Good Clinical Practice. Available at: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integratedaddendum-good-clinical-practice.html

Health Research Authority. Available at: https://www.hra.nhs.uk/

National Institute for Health Research (NIHR) Clinical trial toolkit. Available at: http://www.ct-toolkit.ac.uk/