Managing Clinical Trials: Putting Science into Practice

Module title	Managing Clinical Trials: Putting Science into Practice
Module code	CSC4004
Academic year	2019/0
Credits	15
Module staff	Dr Jenny Lloyd ()

Duration: Term	1	2	3
Duration: Weeks		15

Number students taking module (anticipated)	18

Module description

This optional module will take you through the process of designing and undertaken a clinical trial. It will focus on randomised controlled trial design and the practicalities of managing such a trial. It will consider the practicalities from the perspective of the principal investigator: from building the right team, applying for funding, to resourcing the trial, understanding recruitment and randomisation procedures, selecting outcome measures, collecting and managing data, to analysing and reporting findings.

This module will draw upon the Year Two module, Principles of Medical 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.

Module aims - intentions of the module

This module will provide the information necessary to enable you to understand 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 integrated understanding of the scientific principles underpinning translational research and putting science into clinical practice.
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 and the role of health prevention.
3. Demonstrate an integrated understanding of treatment efficacy 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.
5. Demonstrate an awareness of key human science principles associated with human health, illness and disease.

ILO: Discipline-specific skills

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

1. Not applicable to this module as it is multi-disciplinary

ILO: Personal and key skills

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

6. Manage time, workload, ambiguity, change and stress effectively.
7. Demonstrate professional competence in communicating effectively with patients, healthcare professionals and lay audiences

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
Safety and efficacy
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 and Teaching Activities	30	15 x 2 hour lectures 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
Scientific abstract of assignment	300 words	1-7	Verbal feedback in sessions

Summative assessment (% of credit)

Coursework	Written exams	Practical exams
60	0	40

Details of summative assessment

Form of assessment	% of credit	Size of the assessment (eg length / duration)	ILOs assessed	Feedback method
Written assignment	60	1500 words	1-7	Written (tutor)
Abstract of presentation (as a plain English summary)	10	300 words	1-7
Oral presentation (20%) and discussion (10%)	30	10 minute presentation and 5 minute discussion	1-7	Written, generic group (tutor)

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
Written report (60%)	Written report	1-7	Ref/def
Abstract of presentation as a plain English summary (10%)	Abstract of presentation	1-7	Ref/def
Oral presentation and discussion (30%)	Oral presentation and discussion	1-7	Ref/def

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

Key words search

Managing Clinical Trials

Credit value	15
Module ECTS	7.5
Module pre-requisites	CSC2012 Disease, Diagnostics and Therapeutics. CSC2014 Principles of Medical Research.
Module co-requisites	CSC4020 Research Project.
NQF level (module)	6
Available as distance learning?	No
Origin date	19/10/2015
Last revision date	10/05/2016