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.
Many research questions cannot be effectively answered in a simple parallel trial design or can be more efficiently answered within an advanced design. This module 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 modules 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 module 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 the module, students will be equipped with an understanding of the available designs and when and where they are applicable.
Method of Teaching
The module involves a variety of teaching methods, including lectures, seminars, tutorials, practical classes/workshops and guided independent study.
By the end of the module 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 module, 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.
Module Attendance Required
2 block week of teaching
- A 2-hour unseen examination (40%)
- 2500-word design task (60%)
Academics involved in the delivery of this module
Mr Piers Gaunt
Mr Richard Fox
Stand Alone Course
- An interest in evidence-based practice
- 2:1 honours degree (or equivalent) in a health or life sciences related subject (for example, medicine, pharmacy, nursing, psychology, health sciences), medical statistics or health economics
- Individuals not meeting the above requirement who have equivalent relevant work experience will be considered on an individual basis.
To apply please contact the programme team at firstname.lastname@example.org