Module Catalogue 2024/25

Pre Requisite Comment

none

Co Requisite Comment

none

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

Intended Knowledge Outcomes

Upon completion of this module students will be able to:

• distinguish between the different phases of drug trial and identify the key features of Phase I to Phase IV trials respectively
• identify the key phases in the development and evaluation of a complex intervention
• select the most appropriate design of a trial to address specific research questions and to appraise the strengths and weaknesses of different trials designs
• discuss the key statistical issues in trial design, conduct and analysis, so that they can engage effectively with statisticians in designing and implementing a trial
• engage effectively with health economists in designing and implementing economic evaluations
• discuss the meaning of and importance of consumer engagement in clinical research
• demonstrate an appreciation of the challenges of site and patient recruitment to clinical research studies, and identify strategies for enhancing recruitment and retention rates
• discuss the importance of ‘marketing’ a trial to the relevant stake-holders and be able to propose strategies for doing so
• describe the role of the NIHR topic-specific and comprehensive research networks in supporting clinical research and appreciate how to engage with these networks
• identify different types of costs in clinical research and cost a study realistically

Intended Skill Outcomes

Upon completion of this module students will be able to:

• Critically appraise and select appropriate patient reported outcome measures for application in clinical research
• Critically appraise a clinical trial proposal for funding or protocol for an existing trial
• Design a trial to address a particular clinical research question

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 Canvas VLE through a series of guided learning opportunities including e-based tutorials, online discussion boards, wiki's and blogs. Work will be submitted via Canvas VLE for assessment.

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).

General Notes

N/A