Aims

The module aims to develop the students’ knowledge and understanding of the pharmacological and toxicological principles relevant to drug discovery and development, of the key principles involved in developing a drug from first use in man to licensing and early clinical use, and of the design, conduct and regulation of clinical trials in humans.

Outline Of Syllabus

The module covers the following topics, delivered through a series of lectures and formative assessments delivered through e-learning, supported by weekly interactive face-to-face seminars.

UK Research Infrastructure, Research Networks

Research governance and ethics, Good clinical practice

Clinical phases of drug development, phase I-IV trials

Clinical trial design

Statistical analysis of data

Patient recruitment, data collection and management

Monitoring safety

Interpreting, presenting and publishing results of clinical trials

Drug licensing in the EU and USA

Critical appraisal and economic evaluation

Post-marketing surveillance

Teaching Rationale And Relationship

Basic knowledge and information will be provided by e-learning via Blackboard. Weekly interactive seminars, delivered face-to-face, will provide activities and tasks which will encourage students to reflect individually on their previous week’s learning. Students will be asked to work in small groups and use that knowledge to solve problems or undertake tasks relating to different aspects of clinical trials in man such as writing a clinical trial protocol or write a patient information sheet. Seminars also provide an opportunity to develop other skills including interpersonal and oral communication, collaboration and information literacy.
Private study is used for self-directed learning including further reading, preparation for the seminars, undertaking a piece of written coursework and preparing for examinations.

Assessment Rationale And Relationship

The essay-based written examination will test in-depth understanding and knowledge of material covered during the course relating directly to the intended knowledge outcomes, and also the ability to articulate this knowledge clearly in writing. The written report will test achievement of the stated intended skills outcomes and ability to apply these skills to a specific case study.