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

Module

Clinical Trials

Module titleClinical Trials
Module codeHPDM056
Academic year2021/2
Credits15
Module staff

Dr Shelley Rhodes (Convenor)

Duration: Term123
Duration: Weeks

5

Number students taking module (anticipated)

16

Description - summary of the module content

Module description

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.

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

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 and teaching

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

Scheduled Learning and Teaching ActivitiesGuided independent studyPlacement / study abroad
351150

Details of learning activities and teaching methods

CategoryHours of study timeDescription
Scheduled learning & teaching activities14Lectures, seminars, master-classes to enhance learning through introduction to key topics, specialist areas and contemporary debates. Due to Covid, the following may apply: - Face-to-face scheduled lectures, seminars and master-classes may be replaced with short pre-recorded videos for each topic (15-20 minutes) and/or brief overview lectures delivered via MS Teams/Zoom, with learning consolidated by self-directed learning resources and ELE activities. - Workshops involving face-to-face classroom teaching may be replaced by synchronous sessions on Teams/Zoom; or Asynchronous workshop activities supported with discussion forum
Scheduled learning & teaching activities21Small group work, workshops and case-based discussions to foster critical thinking and academic/research skills development with opportunities for peer and tutor feedback. Due to Covid the following may apply: Small-group work, discussions and workshops may be replaced by synchronous group discussion on Teams/ Zoom; or asynchronous online discussion, for example via Yammer or ELE Discussion board
Guided independent study66Web-based learning; resource gathering and in-depth reading during the period of module delivery.
Guided independent study49Preparation and writing of assignments.

Assessment

Formative assessment

Form of assessmentSize of the assessment (eg length / duration)ILOs assessedFeedback method
Small group projectsVarious and ongoing4-6Verbal
Case-based discussionsVarious and ongoing1-3Verbal

Summative assessment (% of credit)

CourseworkWritten examsPractical exams
70030

Details of summative assessment

Form of assessment% of creditSize of the assessment (eg length / duration)ILOs assessedFeedback method
Individual presentation. Due to Covid, the presentation may take place online via Zoom/Teams3020 mins presentation to peers and tutors1-6Verbal feedback
Coursework assignment702000 words (maximum)1-6Written feedback
0
0
0
0

Re-assessment

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

Original form of assessmentForm of re-assessmentILOs re-assessedTimescale for re-assessment
Coursework assignment (70%)Coursework assignment1-6Typically within six weeks of the result
Individual presentation (30%)Individual presentation to module tutor (20 minutes)1-6Typically 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/

 

 

Resources

Indicative learning resources - Basic reading

 

Basic reading:

 

 

 

• Friedman et al. (Eds.) Fundamentals of Clinical Trials, 4th  Edition, 2010, Springer: New York  

 

• Walker, DM (ed) An Introduction to Health Services Research, 2014, Sage: London. 

 

• Gordis L. Epidemiology. 5th Edition, Elsevier Saunders, 2014.  Available as an online book via the University of Exeter catalogue. 

 

• Coggon D, Rose G, and Barker DJP. BMJ Epidemiology for the uninitiated.  Available as a free download from the BMJ website:   http://www.bmj.com/about-bmj/resources-readers/publications/epidemiology-uninitiated 

 

• Bowling A, Ebrahim S. Handbook of health research methods: investigation, measurement and analysis. Chapter 5: Features and designs of randomized controlled trials and non-randomized experimental designs. Maidenhead: Open University Press, 2005. (Available from Exeter Library as online text)

Getting Started in Health Research

A Paperback edition by David Bowers and Allan House (10 Jun 2011)

MRC Guidance. Developing and Evaluating Complex Interventions: new guidance. 2008. http://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/

 

Indicative learning resources - Web based and electronic resources

ELECollege to provide hyperlink to appropriate pages

A full list of recommended resources will be available of the University of Exeter’s electronic learning environment (ELE, http://as.exeter.ac.uk/it/systems/ele/), including the following:

 

The UKTMN Guide to Efficient Trial Management   https://www.tmn.ac.uk/general/custom.asp?page=Guide 

Barker D, McElduff P, D’Este C, Campbell MJ. Stepped wedge cluster randomised trials: a review of the statistical methodology used and available. BMC Medical Research Methodology, 2016; 16:69. 

Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, et al. (2016) Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS ONE 11(3): e0150205. doi:10.1371/journal.pone.0150205 

Eldrigdge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC. Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clinical Trials, 2004; 1(1):80-90. 

Erik von Elm et al. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ, 2007;335 

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomized trials. BMJ, 2010;340:c869. 

Richards, D.A., (2015). Chapter 18, Feasibility in Practice: Undertaking a feasibility study to answer procedural, methodological and clinical questions prior to a full-scale evaluation. In: Richards, D.A., Rahm Hallberg, I. (eds). Complex Interventions in Health: an Overview of Research Methods. London, Routledge.

Module has an active ELE page

Key words search

Clinical trials, Observational, Experimental, Study designs

Credit value15
Module ECTS

7.5

Module pre-requisites

None

Module co-requisites

None

NQF level (module)

7

Available as distance learning?

No

Last revision date

15/09/2020