The module will explore the key concepts and processes used in translating novel drug development into clinical application. The development of pharmaceutical trials throughout history will be discussed to contextualise current ethical practices together with horizon scanning key challenges related to emerging therapeutic technologies (for example genomic medicine).

The practical challenges of clinical trial protocol development will be discussed from the ‘first in man’ trial of new chemical entities through to post-market surveillance (phase I, II, III and IV clinical trials) together with the supporting legislative and regulatory framework. The roles of principal investigators and study coordinators will be discussed together with clinical trial management and adverse incident investigation.

“Good Clinical Practice” will be embedded throughout the module and students will critically appraise clinical trial design and reporting to identify and develop best-practice.

Students will be required to complete two pieces of summative assessment:

Zero-weighted time constrained on-line test to demonstrate Good Clinical Practice competencies (achieve pass mark of 60%) LO 1

100% Written assignment (essay or report). 3000 words max. LOs 2-4 Final summative assessment.

World Health Organisation, 2002, Handbook for Good Clinical Research Practice WHO Geneva

Medicines and Healthcare Products Regulatory Agency, 2012, Good Clinical Practice Guide MHRA London

Wang D; Bakhai A., 2005, Clinical Trials: a practical guide to design, analysis and reporting ReMedica London

None.

1. Demonstrate a systematic understanding of key aspects of the methodologies used at the different stages of drug trials
(KNOWLEDGE & UNDERSTANDING)

2. Evaluate, assess and develop drug trial methodology with reference to appropriate legal and regulatory frameworks, critically assessing the validity of each stage
(ENQUIRY, LEARNING)

3. Provide considered opinion and critical analysis of ethical issues within clinical drug trials
(ANALYSIS, REFLECTION)

4. Communicate and analyse information, ideas, problems, and solutions to support discussion of safe and effective drug trials with reference to current research and practice
(COMMUNICATION, ANALYSIS)

Lectures and seminar discussion in smaller groups of issues related to lectures including problem-based learning and reflection on directed reading.

Directed reading, research and independent study is required in this module.