MCR8015 : Clinical Trials (E-learning)
- Offered for Year: 2017/18
- Module Leader(s): Dr Jennifer Wilkinson
- Lecturer: Prof. Elaine McColl
- Teaching Location: Off Campus
|Semester 2 Credit Value:||10|
|Semester 3 Credit Value:||10|
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.
Practical aspects of trial design and conduct, including ‘marketing’ the trial, consumer involvement and engagement with clinical research networks, will also be considered. The module is designed to provide students with a firm basis for appraising existing and proposed trials, and for designing 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
|Guided Independent Study||Assessment preparation and completion||2||30:00||60:00||Assessments|
|Guided Independent Study||Directed research and reading||10||6:00||60:00||Online content|
|Guided Independent Study||Skills practice||1||2:00||2:00||Software|
|Guided Independent Study||Reflective learning activity||10||2:00||20:00||eJournal/Blog|
|Guided Independent Study||Student-led group activity||6||2:00||12:00||Wiki|
|Guided Independent Study||Independent study||10||3:00||30:00||Supplemental reading|
|Guided Independent Study||Online Discussion||8||2:00||16:00|
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.
The format of resits will be determined by the Board of Examiners
|Written exercise||3||M||55||Critical review and selection of patient reported outcome measure(s) for a specific study (2000 words).|
|Written exercise||3||M||35||Review of funding proposal for a clinical trial (2000 words).|
|Portfolio||3||M||10||Participation 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.
Written communication, planning and organisation and information literacy are practiced and assessed in the critical review and selection of patient reported outcome measures and in the review of a funding proposal for a clinical trial. Interpersonal communication is practiced and assessed in a written format in both assessments. Clear communication is crucial in both of these written pieces. Computer skills are practiced through the use of Word and for accessing pertinent information for the two reviews for assessment. Adaptability, initiative, some numeracy and problem solving are practiced in the module and may be critical in the production of these two reviews also.
A participation grade is included to encourage and reward the student's engagement with the
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 List Website : rlo.ncl.ac.uk