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Clinical Trials

Module description

This is an online module.

This module will focus on clinical trials in an applied health research setting, with a focus on current trends in clinical trial design. You will learn how to evaluate health care technologies, including complex interventions, using a range of observational and experimental trial methods, from standard randomised clinical trials to pilot/feasibility studies, cluster trials, stepped wedge, observational and non-randomised designs. On top of covering different trial designs, through structured practical sessions, you will learn how to navigate the intricate connections between research ethics, sponsor and governance; to design a case report form; to plan and achieve successful recruitment; to implement good project management skills. You will develop competencies in the design, conduct, analysis and interpretation of experimental and observational study designs. You will critically use different research reporting standards to plan and disseminate the findings of clinical trials that involve patients or community-based participants. At the end of the course, you will have a grasp of key methods that underpin a robust, ethical and well managed clinical trial in either the health service or commercial sector.

Module aims - intentions of the module

You will develop competencies in the design, conduct, analysis and interpretation of experimental and observational study designs. You will critically use different research reporting standards to plan and disseminate the findings of clinical trials that involve patients or community-based participants. At the end of the course, you will have a grasp of key methods that underpin a robust, ethical and well managed clinical trial in either the health service or commercial sector.

Intended Learning Outcomes (ILOs)

ILO: Module-specific skills

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

• 1. Critically evaluate, analyse and address the design and conduct of observational studies in healthcare settings
• 2. Critically evaluate, analyse and address the design and conduct of experimental studies in healthcare settings

ILO: Discipline-specific skills

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

• 3. Recognise how observational studies and experimental studies, with different sources of bias and uncertainty, may contribute to our understanding of the effectiveness of health care interventions
• 4. Demonstrate an understanding of how feasibility and pilot studies support the development of research methods

ILO: Personal and key skills

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

• 5. Apply appropriate techniques to assist designing, conducting and reporting of trials, including structuring of case report form, tools for successful recruitment and good management skills
• 6. Examine specific policies within the healthcare system that influence and govern high quality research

Syllabus plan

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

• Introduction to clinical trials – How to choose between observational and experimental study design to address different types of healthcare research questions

• Clinical trials – with extensions to RCT, cluster RCT, stepped-wedge trial

• Observation studies – with extensions to genetic epidemiology

• Feasibility and pilot studies

• Current trends in clinical trial design

• Research ethics and governance, funding, project management, budgeting and monitoring

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

Same as for the original summative assessment, to include response to the written feedback and undertaken during the University’s agreed referral/deferral period.  

If it is impractical for reassessed presentation to be given in person then a video-conferenced/Skype presentation or a video submission may be accepted at the assessor’s discretion. Same as for the original summative assessment, to include response to the written feedback and undertaken during the University’s agreed referral/deferral period.

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