Early Phase Clinical Trials
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.
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.
Method of Teaching
The module involves a wide variety of teaching methods led by academic trialists at the University of Birmingham, including lectures, seminars, tutorials, practical classes/workshops and guided independent study. Students will also perform hands-on analysis and visualisation using R and RStudio.
By the end of the module 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.
Module Attendance Required
1 block week of teaching
14-18 March 2022
- A 2 hour unseen examination (100%)
Academics involved in the delivery of this module
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