Design and Delivery of Further Clinical Trials
This is a core module on the MSc/PGDip Clinical Trials programme. It is available as an optional module on the PGCert when taken alongside the following modules:
- Rationale for Clinical Trials, Key Concepts and Features
- Analyses of Clinical Trials, Interpretation and Communication of Trial Findings
It can also be taken on a stand-alone basis.
Overview
Many research questions cannot be effectively answered in a simple parallel trial design or can be more efficiently answered within an advanced design. This short course introduces examples of advanced designs, such as adaptive, cluster, factorial and cross-over trials, building on the key concepts and features of clinical trial design and their delivery, considered in earlier courses within the programme. The benefits and challenges of each design will be considered from the perspectives of different stakeholders, including patient, funder, investigator, biostatistician and trial management staff. The course also considers feasibility studies and pilot trials (often needed to inform a definitive trial in the evaluation of a complex intervention or for difficult to recruit to trials), and how qualitative research can be embedded within trials to more efficiently answer research questions.
By the end of this short course, students will be equipped with an understanding of the available designs and when and where they are applicable.
Method of Teaching
This short course involves a variety of teaching methods, including lectures, seminars, tutorials, practical classes/workshops and guided independent study.
Learning Outcomes
By the end of this short course you should be able to:
- Summarise the role and key features of feasibility studies and pilot trials to inform complex trials and illustrate how qualitative methods can be used to more efficiently answer research questions.
- Describe the key features of advanced trial designs covered in the course, and explain how each design differs from a simple parallel randomised trial.
- Evaluate the impact of a specific trial design on patients and investigate what aspects of the design may or may not encourage participation.
- Evaluate the impact of each trial design on investigators and trial management groups, the logistical challenges of such designs, and the trade-off between parsimonious and statistically efficient designs, incorporating the funder’s perspective.
- Recognise regulatory and non-regulatory requirements associated with the design and reporting of each trial design.
- Describe the statistical implications, in terms of design and analysis, of each trial design.
- Design and critically appraise an appropriate trial under specified conditions.
Attendance Required
2 block week of teaching.
Assessment
A 2-hour unseen examination (40%)
2500-word design task (60%)
Academics involved in the delivery of this course
Mr Piers Gaunt
Prerequsites
Pre-existing knowledge required - require introductory knowledge of introduction to RCT trial design or experience working within trials.
To apply please contact the programme team at clinicaltrialsmsc@contacts.bham.ac.uk