MSc Model-based Drug Development - Pharmacokinetic and Pharmacodynamic Modelling / Course details

This introductory unit provides an overview of the basic requirements and procedures employed in planning and conducting clinical trials. It also provides guidance on ethical, regulatory and statistical aspects as well as the managerial requirements.

The unit aims to enable students to:

• acquire and develop an advanced knowledge and in depth understanding of the theory of setting up and running clinical trials
• acquire and develop the advanced skills to make an effective contribution to clinical trial practice
• demonstrate the ability to analyse the different clinical trial phases and the purpose of each
• identify their own learning needs, develop themselves as critically reflective practitioners and advance their own learning to sustain continuing professional development
• critically evaluate literature, theories and methodologies and apply approaches to creating a clinical trials project plan.

Students are provided with the learning material in soft copy form. The learning material comprises 14 chapters covering the key concepts relating to clinical trials. Each chapter contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. A reference list of further reading is provided at the end of the unit allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.

Students should be able to demonstrate an advanced knowledge and detailed understanding of:

• historical background of how clinical trials have developed and evolved to modern standards
• drug development process
• basic requirements for developing and conducting clinical trials
• practical and theoretical aspects of the design, conduct, analysis of outcomes and reporting of clinical trials
• ethical and regulatory aspects of the proper conduct of clinical trials.

Students should be able to critically analyse, evaluate and where appropriate formulate an informed opinion about:

• clinical trial reporting
• impact of poor practices in clinical trial conduct
• effectiveness of current systems and processes.

Students should be able to: 

• analyse approaches to project management
• offer guidance on Project Management in Clinical Trials, including Project Management Tools and how to use them effectively, and how to
• plan approaches to manage when things don’t go as planned, for example when there are unexpected outcomes or accidents in the conduct of clinical trials
• complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material
• engage in critically reflective practice as a process of continuous personal development
• network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation.

Students will be able to: 

• critique information from a range of sources to formulate opinions
• project manage in accordance with organisational requirements, demonstrating high level knowledge on a process driven approach
• assess current working practices based on knowledge and experience gained and adapt working practices as necessary
• prioritise and effectively manage time to complete work by required deadlines.

Marks and feedback sent by email within 15 working days.

• Di Giovanni I and Hayes G (2001). Principles of Clinical Research. Wrightson Biomedical Publishing: Petersfield (UK), Philadelphia (USA).
• Greenhalgh T (2001). How to Read a Paper. Published by BMJ.
• Griffin JP and O’Grady (2002). The Textbook of Pharmaeutical Medicine. Ed. Published by BMJ.
• Machin D, Day S and Green S (2004). Textbook of Clinical Trials. John Wiley & Sons; Chichester.
• Wang D, Bakhai A (2006). Clinical Trials: A Practical Guide to Design, Analysis, and Reporting. Published by Remedica.