Novel Clinical Trial Design in Translational Medicine

Course overview

Translational and experimental medicine is one of the fastest-growing areas of biomedical research. It aims to take findings from discovery science to develop and improve diagnosis, prognosis or therapeutic inventions and ensure that they are applied for patient benefit in clinical practice. How we set up and deliver experimental medicine is of importance to society, as illustrated by the impact clinical trials had during the COVID-19 pandemic– a period which saw rapid development in trial delivery. 

In this course you will discover how recent developments in trial design, including adaptive platform designs, digital delivery and endpoints, are transforming therapy development in clinical science. Drawing on the expertise of world-acknowledged experts in the field you will gain an overview of translational and experimental medicine, as well as the various types of traditional and novel trial designs that are utilised, through real clinical examples, with a focus on the role of digital technology and a patient-centred approach. 

This course will provide you with the knowledge to transform any clinical problem into a practical plan of action by adopting methods you’ve learned on the course to design a clinical study, and placing the patient at the centre of your work. 

What will I learn?

By the end of the course you will be able to:  

• summarise the concept of translational medicine with relevant examples from clinical practice. 
• outline the differences between classical experimental medicine methodology and novel methodology and explain how they both relate to established clinical trials 
• analyse the different requirements of therapies in the modern treatment era, spanning drug development, gene and cell therapies, and devices and technology 
• explain the impact that clinical trial methodology has on patients and how a digital and patient-centered approach influences trial methodology and design
• design a clinical trial to address a given clinical scenario by adopting methods taught on the course, explaining the choices in that scenario and weighing the advantages and disadvantages of the chosen clinical trial.

Who is this course for?

The course targets people with at least a good degree in a related biomedical discipline or individuals with demonstrable experience and/or qualifications which would allow them to successfully complete the content. In particular, this course is for: 

• established employees in the pharmaceutical or healthcare sectors who are looking to upskill or learn more about novel and digital trial design 
• undergraduate or postgraduate students looking for a career in pharmaceutical or healthcare settings.

Course delivery

Our certificated courses reflect the Cambridge experience and values, with low student to tutor ratios and academically rigorous standards. Our learning model is designed to help you advance your skills and specialise in emerging areas that address global challenges. We will help you build your network through an engaging and impactful learning journey that encourages collaboration. Courses are delivered in weekly modules, allowing you to plan your time effectively. The assessment criteria will be presented to you at the start of the course, so you can approach your studies with confidence and motivation, knowing what is expected of you and how to meet those expectations. 

Throughout your online learning experience, you will have access to your course tutor, who will help facilitate your learning and provide you with support and guidance during your studies. You can interact with your tutor through a range of media, such as live sessions, discussion forums, email or canvas messaging. 

Each course includes a balance of:

• interactive learning and real-world application so you can directly apply what you’re learning to your own context
• diverse teaching methods to enhance learning outcomes which will be delivered via learning activities such as University of Cambridge academic led videos, quizzes and group work  
• optional live sessions (1 hour) with University of Cambridge academics and tutors to deepen your understanding of the week's material. These sessions may include an informal Q&A, a short lecture or a breakout activity that builds on the content introduced that week. All sessions are recorded and made available to stream so you can catch up whenever suits you
• guided critical thinking via our reflective workbook so you can collect, structure and summarise information and your thoughts as you progress through the course. 

What will I get on completion?

Evidence your learning with a Certificate of Achievement from the University of Cambridge on successful completion.