Novel Clinical Trial Design in Translational Medicine

Translational and experimental medicine is one of the fastest-growing fields in biomedical research – focusing on turning scientific discoveries into practical solutions for patient care. How we design and implement experimental medicine is critical to the health of our society, as illustrated by the transformative role clinical trials played during the COVID-19 pandemic – a period that saw rapid development in trial delivery.

In this cutting-edge eight-week course, you’ll explore how recent advances in trial design – including adaptive platforms, digital delivery and new endpoints – are reshaping therapy development in clinical science.

Drawing on the experience of experts from the University of Cambridge, you’ll gain practical insights into translational and experimental medicine through real-world clinical examples. With a focus on the integration of digital technology and a patient-centred approach, you will learn a variety of ways to run clinical trials, as well as explore how to design trials to improve patient outcomes.

By the end of the course, you will be equipped with the knowledge to transform clinical problems into actionable plans that can be applied to areas such as repurposed drugs, medical devices, public health interventions or therapies. And, crucially, you’ll be empowered to design clinical studies that place patients at the heart of your work.

This course equals 64 hours of the CPD Certification Service(Opens in a new window) time.

This course starts with an introduction to translational and experimental medicine, covering drug discovery and therapy development. You’ll explore traditional trial designs, focusing on randomised controlled trials, and learn about novel treatment methods like gene therapies and digital technologies. The course also examines the challenges of digital trial delivery and the importance of a patient-centred approach. Real-world examples, including those from the pandemic, will be used to analyse trial design strengths and weaknesses, culminating in an assignment focused on clinical scenarios.

• Module 1: Introduction to translational and experimental medicine

• Module 2: Traditional trial designs

• Module 3: Novel methods of trial design

• Module 4: Novel methods of trial delivery

• Module 5: Review and integration week

• Module 6: The patient-centred trial

• Module 7: Real-world exemplars of novel trial design

• Module 8: Assessment completion

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.

On successful completion of the course, you’ll receive a certificate from the University of Cambridge, along with valuable Continuing Professional Development (CPD) points and a digital badge to display on your LinkedIn profile. These Cambridge credentials not only showcase your knowledge and expertise, but also demonstrate your commitment to professional development – helping to future-proof your career.

This course is designed for professionals with a strong background in biomedical science, either through a relevant degree or demonstrable experience and qualifications in the medical or pharmaceutical sector.

• Established professionals in the pharmaceutical or healthcare sectors: Designed to upskill and deepen understanding of novel and digital trial design methodologies.

• Undergraduate or postgraduate students: Ideal for people seeking a career in pharmaceutical or healthcare settings, eager to learn about the latest advancements in clinical trial design and patient-centred approaches.

The course assumes participants have a foundational knowledge of biomedical science and therapeutic development pipelines, enabling them to engage fully with the advanced content covered.

Our flexible, online courses – delivered via a world-leading learning platform – reflect the University of Cambridge experience and values, with low learner-to-tutor ratios and academically rigorous standards.

Our online learning model is designed to help you advance your skills and specialise in emerging areas that address real-world challenges. We will help you build your network through an engaging and impactful learning journey that encourages collaboration with academics and fellow learners.

Courses are delivered in weekly modules, allowing you to plan your time effectively around existing commitments. 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 exactly what’s expected of you and how to meet those expectations.

Throughout your online learning experience with Cambridge Advance Online, you’ll have digital access to a dedicated course tutor, an expert in the field, who will help steer your learning and provide you with support and guidance every step of the way.