Module Catalogue

MCR8015 : Clinical Trials (E-learning)

  • Offered for Year: 2017/18
  • Module Leader(s): Dr Jennifer Wilkinson
  • Lecturer: Prof. Elaine McColl
  • Owning School: FMS Graduate School
  • Teaching Location: Off Campus
Semesters
Semester 2 Credit Value: 10
Semester 3 Credit Value: 10
ECTS Credits: 10.0

Aims

This module is designed to expand upon principles of the design, conduct and analysis of clinical trials. Students will be introduced to the principles and practices of the design and conduct of trials of both pharmaceutical and complex interventions, assessing the efficacy, effectiveness and cost-effectiveness of the trialled interventions. The module is designed to equip students with the skills required both to critically appraise all aspects of trials designed by others and to design and implement their own trials.

Outline Of Syllabus

The module covers the following subjects:

The drug development process, from bench to bedside
Phase I to Phase IV drug trials, their purpose and design
Patient safety and pharmacovigilance
The role of NICE and other bodies in bringing drugs and technologies into routine clinical practice
Different trial designs (parallel group, cross-over, factorial designs, equivalence trials, non-inferiority trials etc) – their advantages and disadvantages
Explanatory vs. pragmatic trials
Statistical considerations in clinical trials (including sample size calculations)
Economic evaluation alongside trials, including economic modelling
Patient reported outcomes, their choice and application
Recruitment to studies
The MRC framework for complex interventions
The nature and role of pilot studies
‘Marketing’ clinical trials
Consumer involvement in clinical and health-related research
Costing a research study
The role of clinical research networks in supporting trials and other high quality clinical research

Teaching Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Guided Independent StudyAssessment preparation and completion230:0060:00Assessments
Guided Independent StudyDirected research and reading106:0060:00Online content
Guided Independent StudySkills practice12:002:00Software
Guided Independent StudyReflective learning activity102:0020:00eJournal/Blog
Guided Independent StudyStudent-led group activity62:0012:00Wiki
Guided Independent StudyIndependent study103:0030:00Supplemental reading
Guided Independent StudyOnline Discussion82:0016:00
Total200:00
Teaching Rationale And Relationship

Students will learn about the principles of the design, conduct and analysis of clinical trials. Students will gain the knowledge and skills required both critically appraise all aspects of trials designed by others and to design and implement their own trails.
The module will be delivered by e-learning using Blackboard VLE through a series of guided learning opportunities including e-based tutorials, online discussion boards, wiki's and blogs. Work will be submitted via Blackboard VLE for assessment.

Assessment Methods

The format of resits will be determined by the Board of Examiners

Other Assessment
Description Semester When Set Percentage Comment
Written exercise3M55Critical review and selection of patient reported outcome measure(s) for a specific study (2000 words).
Written exercise3M35Review of funding proposal for a clinical trial (2000 words).
Portfolio3M10Participation in collaborative e-learning activities throughout the module (Discussion Board, Blog, Wiki).
Assessment Rationale And Relationship

In the first written assignment, students will be presented with a specific study scenario and will be asked to identify and review candidate measures of patient reported outcomes, and to make a recommendation as to which measure(s) would be the most suitable for use in the specific study scenario.

The second assignment involves a structured review (using the funding body’s peer review form) of a funding proposal for a clinical trial will require students to integrate their learning across this module including practical skills regarding drug trials and complex interventions and involvement of consumers and key stakeholders in research as well as key aspects of health economics (and indeed to draw on learning from other modules), and to comment on the scientific and practical aspects of the proposed study.

A participation grade is included to encourage and reward the student's engagement with the
collaborative activities.

Should a student fail the participation assessment and have to undertake a re-sit they will have to
complete a different form of assessment. The student will be asked to look at 2 participation
activities as identified by the module leader/team and submit a 500 word written summary (approx. 250 words per activity).

Reading Lists

Timetable