Translational Medicine

Learning Outcomes

Knowledge and Understanding

Having successfully completed this module, you will be able to demonstrate knowledge and understanding of:

• Evaluating the range of clinical study designs available for assessment of novel devices, processes or software solutions
• Analysing the results of clinical studies using appropriate statistical tests
• Planning the primary outcomes of a clinical study to obtain a clear result and be able to differentiate between these primary outcomes and more secondary or exploratory outcomes
• The pathways for obtaining funding for clinical trials and routes to commercialisation of new technologies, including an appreciation of the technology life cycle
• Designing a clinical study that takes into account all ethical, legal and practical considerations
• Appraising the quality of clinical studies to differentiate between ethically run, well designed clinical studies and those that are not
• The key regulatory bodies involved in oversight and conduct of pre-clinical and clinical research studies, the key legislation underpinning these bodies and the roles and responsibilities of each organisation
• Developing solutions to complex clinical problems with a specific emphasis on patient impacts

Transferable and Generic Skills

Having successfully completed this module you will be able to:

• Develop skills relating to lifelong professional learning
• Develop oral presentation skills
• Develop relationships to enable effective interdisciplinary work
• Plan and implement tasks at a professional level
• Engage in self-directed and reflective learning
• Engage in self-directed and reflective learning
• Develop good communication skills (written, listening and verbal).
• Deal with complex clinical and scientific issues both systematically and creatively

Postgraduate study skills:

Information for writing assignments: Scientific and IT skills for report writing, How to read a scientific paper / Critical appraisal, Academic Integrity, Managing references (searching, storing, citing)

Clinical study conduct

NIHR-accredited Good Clinical Practice (GCP) training

Research Design

Pre-clinical models

National Research Ethics Service (NRES)

Medicines & Healthcare Regulatory Authority (MHRA

Public-patient involvement/engagement

Commercialisation

National Institute for Health & Care Excellence (NICE) and Clinical Commissioning Groups (CCG) – Introduction to these organisations and how decisions are made to implement new technologies in the UK NHS

Funding clinical studies and commercialisation of research – introduction to the funding streams available for trialling new healthcare technologies and possible routes to commercialisation

4 Case studies

Tutorials based on a clinical problem where possible solutions will be explored. Students will work in multidisciplinary teams to design a clinical study which they will present.

Case studies may include:

Harnessing nanoclays for tissue regeneration

Intravascular ultrasound for diagnosis and treatment of coronary artery disease

Intelligent medical sensors for real-time disease monitoring

In vivo imaging of antibody therapies

Transferrable Skills

IT skills

Referencing

Communication skills

Oral presentation skills

Reflection

Multidisciplinary team working

A variety of learning and teaching methods will be adopted to promote a wide range of skills and meet the differing learning styles of the group.

The techniques will include seminars, practical demonstrations and exercises surrounding interpretation of data and clinical scenarios.

Specialist lecturers from a range of academic and health care professional backgrounds will be used to ensure a breadth and depth of perspective is offered, giving a good balance between background theories and principles and practical management advice.

Formative

This is how we’ll give you feedback as you are learning. It is not a formal test or exam.

Assessed Tutorials

• Assessment Type: Formative
• Feedback: Instructor led and peer-peer feedback through discussion during tutorial.
• Final Assessment: No
• Group Work: No

Summative

This is how we’ll formally assess what you have learned in this module.

Referral

This is how we’ll assess you if you don’t meet the criteria to pass this module.