Design and Delivery of Further Clinical Trials20 credits

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 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

1 block week of teaching

Course dates

28 April - 2 May

Assessment

A 2-hour unseen examination (40%)
2500-word design task (60%)

Credits

20 credits

Pre-existing knowledge required - require introductory knowledge of introduction to RCT trial design or experience working within trials.

For further information, please contact the programme team at clinicaltrialsmsc@contacts.bham.ac.uk

Why choose a Postgraduate Microcredential short course?

• Microcredentials offer the perfect opportunity to boost your CV without the commitment of a full degree
• Usually taken from existing modules within a Masters, they can be used as standalone credentials with some also counting as academic credits at postgraduate level
• Add a postgraduate level qualification to your CV
• Develop the specialist skills you need for your career goals
• Alumni status with the University of Birmingham
• Learners will have the same access to our student support and campus facilities as our students on full degree programmes.

Please note the deadline for submitting an application:

• Applicants eligible for Home fees are to apply a minimum of 6 weeks before the module start date.
• Applicants eligible for Overseas fees are to apply a minimum of 3 months before the module start date.

Please note that once registered for the microcredential you cannot swap for the non-credit short course version.

Non-credit short course

The microcredential and the non-credit short course follow the same course structure, the difference between them both is with the non-credit short course you do not take the assessment at the end therefore you will not receive credits but will receive a certificate of completion, this certificate cannot be converted to credits.

Please note if you apply for the non-credit short course, you cannot swap to the microcredential version once registered.

Places on the non-credit short course are limited so please enquire before if spaces are available.