Module Catalogue 2022/23

MCR8008 : Clinical Trials (Inactive)

  • Inactive for Year: 2022/23
  • Module Leader(s): Professor Dawn Teare
  • Lecturer: Dr Alastair Greystoke, Dr Ruben Thanacoody, Dr Lynne Corner, Dr Thomas Chadwick, Dr Alison Steel
  • Owning School: FMS Graduate School
  • Teaching Location: Newcastle City Campus
Semesters
Semester 2 Credit Value: 20
ECTS Credits: 10.0
Pre Requisites
Pre Requisite Comment

N/A

Co Requisites
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 trialed interventions.

Outline Of Syllabus

The drug development process, from bench to bedside
Phase I to Phase IV drug trials, their purpose and design
The role of NICE and other bodies in bringing drugs and technologies into routine clinical practice
Pharmacoeconomics
Explanatory vs. pragmatic trials
The nature and role of feasibility and pilot studies
Patient preference trials
Recruitment and retentions strategies for trials
‘Marketing’ clinical trials
Ethical issues in clinical trials
Different trial designs (parallel group, cross-over, factorial designs, equivalence trials, non-inferiority trials etc) – their advantages and disadvantages
Statistical considerations in clinical trials (including sample size calculations)
Patient reported outcomes, their choice and application
The MRC framework for complex interventions
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

Learning Outcomes

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 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 and engage effectively with statistician colleagues in designing and implementing a trial
• Discuss the key health economics issues in economic evaluation alongside trials, and engage effectively with health economist colleagues in designing and implementing economic evaluations
• Discuss the meaning 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 rate
• Describe the ethical issues associated with specific trial types and contexts
• Discuss the importance of ‘marketing’ a trial to the relevant stake-holders propose strategies for doing so
• Describe the role of the NIHR research networks in supporting clinical research and engage effectively with these networks
• Identify the 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 Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Scheduled Learning And Teaching ActivitiesLecture181:0018:0019 lectures of varying length.
Guided Independent StudyAssessment preparation and completion601:0060:00N/A
Guided Independent StudyDirected research and reading501:0050:00N/A
Guided Independent StudyReflective learning activity201:0020:00N/A
Guided Independent StudyIndependent study521:0052:00N/A
Total200:00
Teaching Rationale And Relationship

Face-to-face contact in this module will take the form of lectures, with group work incorporated into many of these. Self-guided learning, in the form of preparatory and post-session reading for lectures, and preparation of the written assessments.

Reading Lists

Assessment Methods

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

Other Assessment
Description Semester When Set Percentage Comment
Written exercise2M60Critical Review and Selection of Patient Reported Outcome Measure(s) for a Specific Study (max 2000 words).
Written exercise2M40Review of Funding Proposal for a Clinical Trial (max 2000 words).
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 written assignment is in the form of a structured review (using the funding body’s peer review form) of a funding proposal for a clinical trial. This will require students to integrate their learning across this module including practical skills trial design and conduct, 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.

Timetable

Past Exam Papers

General Notes

N/A

Disclaimer: The information contained within the Module Catalogue relates to the 2022/23 academic year. In accordance with University Terms and Conditions, the University makes all reasonable efforts to deliver the modules as described. Modules may be amended on an annual basis to take account of changing staff expertise, developments in the discipline, the requirements of external bodies and partners, and student feedback. Module information for the 2023/24 entry will be published here in early-April 2023. Queries about information in the Module Catalogue should in the first instance be addressed to your School Office.