Course Catalogue

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During this module students will learn about the key issues involved in developing a candidate drug from late stage pre-clinical drug discovery through to clinical implementation, covering the clinical components of target validation and disease linkage, the use of pharmacodynamic biomarkers in early clinical trials and the development of companion diagnostics to enable personalized medicine strategies. Early clinical trials teaching will focus on design elements required to achieve key milestones in early drug development including proof of mechanism, proof of principal and proof of concept.

Lectures, workshops, seminars and tutorials spread over 3 weeks.

Students taking this Drug Development and Clinical Trials course must also take the preceding Drug Discovery course.

Students taking this Drug Development and Clinical Trials course must also take the preceding Drug Discovery course.

Students will be provided with an example of a putative drug and a relevant area of unmet clinical need. Students will be asked to outline and critically evaluate a clinical development programme.

The required word count will be 1500-2000.

The course aims to provide a clear understanding of the principles of Clinical Trials with particular reference to trials involving medicines-it will cover organisational, ethical and regulatory considerations for conducting trials in human subjects, and will include an understanding of how to choose the optimal trial design to achieve the required drug discovery milestones, and how to apply biostatistics to the design process.

By the end of this course students will be able to:

1. Discuss the package of preclinical and clinical information which is required and desirable to support a clinical development programme;

2. Summarise and critically discuss the main phases and decision points of clinical drug development; Critically discuss the regulatory and ethical framework required for the design and implementation of clinical trials in the UK and internationally.;

3. Critically discuss the role of predictive biomarkers and how to integrate them into a drug development programme;

4. Discuss the role of pharmacodynamics and pharmacokinetic biomarkers in early and late stage clinical development;

5. Critically discuss the different types of clinical trial design in common use;

6. Critically evaluate clinical trial publications from all phases of drug development;

7. Design and critically evaluate a clinical trial outline;

8. Critically discuss current issues regarding market access for new technologies from an industrial and health economic perspective.

Students must submit at least 75% by weight of the components (including examinations) of the course's summative assessment.