Novel Clinical Trial Design in Translational Medicine

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 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. There is an optional weekly live session, which is recorded for anyone who can’t attend. 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.

Level of knowledge and experience

• A strong biomedical degree or relevant experience in the medical or pharmaceutical sector that demonstrates a solid understanding of basic biomedical science would be desirable. Participants should also have an awareness of clinical trials, their purpose and ethical design, as well as a basic understanding of therapeutic development pipelines.
• An understanding of the causes of disease, clinical conditions and the challenges of conducting trials with specific patient groups would be helpful.
• You’ll also need a good level of spoken and written English to make the most of the course (we recommend English language proficiency equivalent to an IELTS score of 7).

Materials and equipment

• No specialist software or IT equipment required.
• Sufficient internet speed (2 Mbps up/down) for video streaming.
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Access to Virtual Learning Environment
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You can ask for support from your employer to fund this learning as part of your professional development.

Our Employer Funding guide has practical tips and templates to help you feel more confident asking for funding.

If your employer is funding your course or programme, we have several payment options available, including bank transfer (BACs), credit or debit card, and PayPal.

You can request a quote or an invoice for your organisation via our online course booking form, which will include a payment date and next steps for completing your payment.