The University of Southampton
Courses

MEDI6219 Translational Medicine

Module Overview

The Translational Medicine module gives an overview of the regulatory, ethical and practical requirements of translating novel devices, processes, engineering or software solutions into a clinical setting. The use of pre-clinical models and the UK regulatory framework for using pre-clinical models are introduced. In addition to full training in Good Clinical Practice (GCP) and the design of Clinical Trials, the importance of public-patient engagement with the research design process will also be presented. The funding opportunities for running clinical trials and possible routes for eventual implementation/commercialisation will also be explored. The course will concentrate on the UK regulatory framework as an exemplar, but many of the principles will be appropriate to other national and international regulatory regimes. In addition to a range of lectures from a range of backgrounds, students will form multidisciplinary teams to explore translational solutions relevant to current medical problems under the guidance of tutors who have experience of translational medicine

Aims and Objectives

Module Aims

• Provide you with an overview of the relevant ethical, regulatory and safety principles and requirements of conducting pre-clinical and clinical research • Provide you with skills in clinical research design and enable you to conduct that research to GCP standard • Outline the current pathways to commissioning novel devices, processes or software solutions in the UK NHS • Introduce the funding streams available for trialling new healthcare technologies and possible routes to commercialisation • Provide the opportunity for working in a multidisciplinary team to explore translational solutions to relevant to current medical problems

Learning Outcomes

Knowledge and Understanding

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

  • Appraise the quality of clinical studies to differentiate between ethically run, well designed clinical studies and those that are not
  • List 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
  • Evaluate the range of clinical study designs available for assessment of novel devices, processes or software solutions
  • Explain the pathways for obtaining funding for clinical trials and routes to commercialisation of new technologies, including an appreciation of the technology life cycle
  • Plan 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
  • Design a clinical study that takes into account all ethical, legal and practical considerations
  • Analyse the results of clinical studies using appropriate statistical tests
  • Develop 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:

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

Syllabus

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: Microsensors for real-time detection of anaesthesia levels during surgery Portable, fast, low-cost early-warning device for osteoporosis Intelligent medical sensors for real-time disease monitoring Monitoring microvascular function & tissue health in diabetes Transferrable Skills IT skills Referencing Communication skills Oral presentation skills Reflection Multidisciplinary team working

Special Features

The module will be taught by an international faculty, at the forefront of their respective academic disciplines and professions. Adult learning methods will be used throughout and an emphasis placed upon interactive learning, practical demonstration and the interpretation of clinical scenarios to reinforce learning

Learning and Teaching

Teaching and learning methods

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.

TypeHours
Independent Study120
Teaching30
Total study time150

Resources & Reading list

Module Blackboard site TBC. 

Assessment

Assessment Strategy

A qualifying mark of 40% on each assessed component of the module must be achieved. Each of the component marks is then combined, using the appropriate weighting, to give an overall mark for the module. If the overall mark is less than 50% when the weighting has been applied to the components, this constitutes a failure of the module.

Summative

MethodPercentage contribution
Group Oral Presentation  (10 minutes) 20%
Individual assignment  (3000 words) 80%

Referral

MethodPercentage contribution
Individual assignment  (3500 words) 100%

Repeat Information

Repeat type: Internal & External

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