Clinical Trials
| Module title | Clinical Trials |
|---|---|
| Module code | CSC3008 |
| Academic year | 2021/2 |
| Credits | 15 |
| Module staff | Dr Jenny Lloyd (Convenor) Dr Siobhan O'Dwyer (Convenor) |
| Duration: Term | 1 | 2 | 3 |
|---|---|---|---|
| Duration: Weeks | 12 |
| Number students taking module (anticipated) | 18 |
|---|
Module description
This optional module will take you through the process of managing and designing a clinical trial. It will focus on randomised controlled trial design and the practicalities of undertaking such a trial. It will consider the practicalities from the perspective of the principal investigator and the Trial Manager from building the right team and applying for funding, to resourcing the trial, understanding recruitment and randomisation procedures, selecting outcome measures, collecting and managing data, to analysing and reporting the findings.
This module will draw upon the Year Two modules, Experimental Design and Statistics, 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 enjoyed applying their knowledge to their own trial and noted that the content is applicable to multiple disciplines and increases knowledge of potential job opportunities.
Module aims - intentions of the module
This module promotes the understanding of 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 understanding of the challenges associated with designing and delivering a clinical trial.
- 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, blinding, intention to treat and randomisation.
- 3. Demonstrate an integrated understanding of treatment efficacy and effectiveness 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.
ILO: Discipline-specific skills
On successfully completing the module you will be able to...
- 5. Understand the expected performance standards in relation to scientific probity and multidisciplinary team-based practice.
- 6. Demonstrate an integrated understanding of the scientific principles underpinning translational research and putting science into clinical practice.
- 7. Create a valid research question and design a study to address it.
ILO: Personal and key skills
On successfully completing the module you will be able to...
- 8. Manage time, workload, ambiguity, change and stress effectively.
- 9. Demonstrate professional competence in communicating effectively with patients, healthcare professionals and lay audiences.
- 10. Use feedback and experience to reflect upon your progress
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)
| Scheduled Learning and Teaching Activities | Guided independent study | Placement / study abroad |
|---|---|---|
| 30 | 120 | 0 |
Details of learning activities and teaching methods
| Category | Hours of study time | Description |
|---|---|---|
| Scheduled Learning & Teaching activities | 30 | 15 x 2 hour lectures with small group discussions and practical activities |
| Guided Independent Study | 60 | Preparation for scheduled activities |
| Guided Independent Study | 60 | Assessment preparation |
Formative assessment
| Form of assessment | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|
| Planning your RCT; Research question, rationale, PICO of RCT and clinical phase, key challenges, 3 key references | 0.5 page (~300 words) in a table format | 1-10 | Verbal and/or email feedback. |
Summative assessment (% of credit)
| Coursework | Written exams | Practical exams |
|---|---|---|
| 20 | 0 | 80 |
Details of summative assessment
| Form of assessment | % of credit | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|---|
| Scientific Abstract of presentation | 20 | 0.5 page (~300 words) | 1-10 | Written via E Bart |
| Presentation with discussion (to include script and additional references and resources). | 80 | 10 minute presentation and 5 minute discussion | 1-10 | Written via E Bart |
Details of re-assessment (where required by referral or deferral)
| Original form of assessment | Form of re-assessment | ILOs re-assessed | Timescale for re-assessment |
|---|---|---|---|
| Scientific Abstract of presentation (20%) | Scientific Abstract of presentation 0.5 page (~300 words) | 1-10 | Ref/Def |
| Presentation with discussion (to include script and additional references and resources). (80%) | Presentation with discussion (10 minute presentation and 5 minute discussion) | 1-10 | Ref/Def |
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
| Credit value | 15 |
|---|---|
| Module ECTS | 7.5 |
| Module pre-requisites | CSC2012 Disease, Diagnostics and Therapeutics. CSC2023 Experimental Design and Statistics |
| NQF level (module) | 6 |
| Available as distance learning? | No |
| Origin date | 07/06/2019 |
| Last revision date | 02/12/2020 |
