Early Phase Clinical Trials10 credits

This is a core module on the MSc/PGDip in 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
• Selection, Collection and Reporting of Trial Outcomes
• Analyses of Clinical Trials, Interpretation and Communication of Trial Findings

It can also be taken on a stand-alone basis.

Overview

Medical treatments typically pass through many different trial phases before they are adopted as part of standard of care. Early phase clinical trials, colloquially those at phases I and II, seek to identify promising doses and investigate early efficacy signals of novel treatments. They typically use experimental methods quite distinct from traditional phase III trials.

The first half of this course will cover methods for dose-finding. This phase provides the foundation for subsequent research and errors here can compromise the rest of the trial pathway. As experimental treatments evolve, methodology must also adapt. We will study historic and novel modern approaches for dose-finding, justified by the clinical setting.

The second half of this course will cover early efficacy studies, the general pre-requisite to a larger and more costly confirmatory trial. The perennial challenge here is the level of uncertainty pertaining to the treatment effect, time horizon, method of delivery, adverse events, and patient subgroups.

By the end of this short course you should be able to:

• Explain the typical role, rationale, and objectives of early phase clinical trials.
• Discuss the ethical obligations to patients and critique experimental designs, in light of these obligations.
• Identify, explain and justify the experimental features commonly used in early phase clinical trials.
• Interpret and critically appraise the results from an early phase clinical trial.
• Synthesise existing evidence to create a defensible plan to conduct an early phase clinical trial in an experimental treatment.

Attendance required

1 block week of teaching

Course dates

24-28 March

Assessment

A 2 hour unseen examination (100%)

Credits

10 credits

• Pre-existing knowledge required - knowledge of introduction to RCT trial design or experience working within early phase 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.