Module Catalogue 2024/25

Pre Requisite Comment

None

Co Requisite Comment

Students wishing to graduate in MRes Translational Medicine and Therapeutics (4822F) are required to undertake the co-requisite module Drug Discovery and Development (MMB8006).

All other MRes students may enroll on this module if they wish - timetable permitting.

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

Intended Knowledge Outcomes

By the end of the module students should be able to:

Explain the research governance framework in the UK and the legal requirements before conducting research in man.

State and distinguish the clinical phases of drug development and explain the purpose and key features of each phase.

Describe different trial designs and compare their strengths and weaknesses.

Examine and discuss the importance of blinding, randomisation, choice of control group, choice of appropriate endpoints in the design of clinical trials.

Debate and discuss ethical and funding considerations in clinical trials.

Describe the types and classification of adverse events and the legal requirements for reporting of adverse events.

List the regulatory authorities involved in drug licensing in the UK, EU and US and describe the methods for obtaining marketing authorisation for a drug in the and EU.

Intended Skill Outcomes

By the end of the module students should be able to:

Complete all the requisite applications to conduct a clinical trial in man, including
•       ethics application
•       patient information sheet and consent form
•       clinical trial protocol
•       funding application

Analyse data from clinical research, perform simple statistical analyses and present the results

Critically appraise clinical trial results

Teaching Rationale And Relationship

Basic knowledge and information will be provided by e-learning via Canvas. Weekly interactive seminars, delivered in person, 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 written coursework.

Assessment Rationale And Relationship

The written report will test achievement of the stated intended skills outcomes and ability to apply these skills to a specific case study.

The data analysis coursework will test the ability to perform statistical analysis on a clinical trial dataset and summarise the results as a poster for a scientific audience. This is intended to prepare students for their research project.

General Notes

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