Newcastle University

Aims

This module, ‘Clinical Trials’ (MCR8008), is part of the Clinical Research Programme and 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 focus is on the design and conduct of trials of the efficacy, effectiveness and cost-effectiveness of a range of interventions, including pharmaceutical, surgical and complex interventions. 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 equip students with the skills required to critically appraise all aspects of trials designed by others and to design and implement their own trials.

Outline Of Syllabus

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

Teaching Rationale And Relationship

Face-to-face contact in this module will be a mixture of lectures and seminars/workshops. Self-guided learning, in the form of preparatory and post-session reading for lectures and seminars, and preparation of the written assignments. Students will be assessed through written work, comprising a critical review of a grant application for a clinical research study, and a critical review, with recommendation for choice of measure, of a range of patient reported outcome measures for use in a specific study.

Assessment Rationale And Relationship

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.

In the second 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.

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 commuication 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. Adaptibility, initiative, some numeracy and problem solving are practiced int he module and may be critical in the production of these two reviews also.