Clinical Trials
| Module title | Clinical Trials |
|---|---|
| Module code | HPDM056Z |
| Academic year | 2022/3 |
| Credits | 15 |
| Module staff | Dr Shelley Rhodes (Lecturer) |
| Duration: Term | 1 | 2 | 3 |
|---|---|---|---|
| Duration: Weeks | 5 |
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)
| Scheduled Learning and Teaching Activities | Guided independent study | Placement / study abroad |
|---|---|---|
| 35 | 115 | 0 |
Details of learning activities and teaching methods
| Category | Hours of study time | Description |
|---|---|---|
| Scheduled learning & teaching activities | 14 | Lectures, seminars, master-classes to enhance learning through introduction to key topics, specialist areas and contemporary debates. |
| Scheduled learning & teaching activities | 21 | Small group work, workshops and case-based discussions to foster critical thinking and academic/research skills development with opportunities for peer and tutor feedback |
| Guided independent study | 66 | Web-based learning; resource gathering and in-depth reading during the period of module delivery. |
| Guided independent study | 49 | Preparation and writing of assignments. |
Formative assessment
| Form of assessment | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|
| Small group projects | Various and ongoing | 4-6 | Verbal |
| Case-based discussions | Various and ongoing | 1-3 | Verbal |
Summative assessment (% of credit)
| Coursework | Written exams | Practical exams |
|---|---|---|
| 70 | 0 | 30 |
Details of summative assessment
| Form of assessment | % of credit | Size of the assessment (eg length / duration) | ILOs assessed | Feedback method |
|---|---|---|---|---|
| Individual presentation (via Zoom/Teams) | 30 | 20 mins presentation to peers and tutors | 1-6 | Verbal feedback |
| Coursework assignment | 70 | 2000 words (maximum) | 1-6 | Written feedback |
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 |
|---|---|---|---|
| Coursework assignment (70%) | Coursework assignment | 1-6 | Typically within six weeks of the result |
| Individual presentation (via Teams/Zoom) (30%) | Individual presentation to module tutor (20 minutes) | 1-6 | Typically within six weeks of the result |
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/
| Credit value | 15 |
|---|---|
| Available as distance learning? | Yes |
| Last revision date | 06/09/2022 |
