COLLEGE OF MEDICINE AND HEALTH
Medicine, Nursing and Allied Health Professions

Module

Clinical Trials

Module titleClinical Trials
Module codeCSC3008
Academic year2021/2
Credits15
Module staff

Dr Jenny Lloyd (Convenor)

Dr Siobhan O'Dwyer (Convenor)

Duration: Term123
Duration: Weeks

12

Number students taking module (anticipated)

18

Description - summary of the module content

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

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 and teaching

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

Scheduled Learning and Teaching ActivitiesGuided independent studyPlacement / study abroad
301200

Details of learning activities and teaching methods

CategoryHours of study timeDescription
Scheduled Learning & Teaching activities3015 x 2 hour lectures with small group discussions and practical activities
Guided Independent Study60Preparation for scheduled activities
Guided Independent Study60Assessment preparation

Assessment

Formative assessment

Form of assessmentSize of the assessment (eg length / duration)ILOs assessedFeedback method
Planning your RCT; Research question, rationale, PICO of RCT and clinical phase, key challenges, 3 key references0.5 page (~300 words) in a table format1-10Verbal and/or email feedback.

Summative assessment (% of credit)

CourseworkWritten examsPractical exams
20080

Details of summative assessment

Form of assessment% of creditSize of the assessment (eg length / duration)ILOs assessedFeedback method
Scientific Abstract of presentation 200.5 page (~300 words)1-10Written via E Bart
Presentation with discussion (to include script and additional references and resources).8010 minute presentation and 5 minute discussion1-10Written via E Bart

Re-assessment

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

Original form of assessmentForm of re-assessmentILOs re-assessedTimescale for re-assessment
Scientific Abstract of presentation (20%)Scientific Abstract of presentation 0.5 page (~300 words)1-10Ref/Def
Presentation with discussion (to include script and additional references and resources). (80%) Presentation with discussion (10 minute presentation and 5 minute discussion)1-10Ref/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/

Resources

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

Module has an active ELE page

Key words search

Managing Clinical Trials

Credit value15
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