Delivering complex and innovative trials: Case study library
Case studies demonstrating delivery of complex and innovative trial design
- FOCUS4 - Foundations for fighting COVID-19
Learn how forward-thinking approaches to cancer clinical trials from the last decade have featured in the UK’s fight against COVID-19.
- National Lung Matrix Trial - laying the groundwork for combatting COVID-19
Learn how our history of cutting-edge cancer research underpinned the UK’s COVID-19 research response.
- STAMPEDE - a turning point in trial design
Find out why the STAMPEDE trial is a milestone in the history of clinical trial design in the UK.
- The UK's flagship COVID-19 treatment trial - the RECOVERY trial
The NIHR-supported RECOVERY trial is leading the way in identifying treatments for this new infectious disease.
- REMAP-CAP tests treatments for COVID-19
A nationally-prioritised study which aims to provide answers about the best treatment options for COVID-19 patients who develop pneumonia.
- REMAP-CAP also featured in: Case study: UK achieves site activation world record for Roche during COVID19 pandemic
The UK’s Urgent Public Health response has been applauded by global life science company, Roche.
- TAILoR trial: Adopting an adaptive approach to help HIV patients on antiretroviral therapy (cART)
Finding the right dose of any therapy is crucial and adaptive trial designs offer a novel way of finding the most appropriate dose for licensed drugs being repurposed for another indication.
- Using an adaptive model to trial a new treatment for rare kidney disease
An adaptive trial model is being used to investigate a new drug being developed by Novartis, after showing promising results in the lab.
Case studies demonstrating innovative delivery techniques
RELIEVE IBS-D: Pushing virtual boundaries to improve patient engagement and accessibility
Discover how the NIHR and Enteromed collaborated to deliver the UK’s first fully virtual, commercial, interventional trial for Irritable Bowel Syndrome with Diarrhea (IBS-D).
- PD-STAT: Paving the way for the future of remote trial delivery
Learn how the NIHR supported the PD-STAT trial to transition to a virtual model during the COVID-19 pandemic.
Research register provides rapid access to rare renal disease patients
A research registry in the UK, which provides rapid access to almost 24,000 patients with rare renal disease, is transforming how research in rare renal conditions is done, and making the UK an attractive prospect for new academic and commercial studies.
NURTuRE: New biobank brings a wealth of new opportunities for UK renal research
Research registries and biobanks present an efficient way of doing research. In the UK the life sciences industry, charities and academia are collaborating to maximise this new approach and open up a wealth of new opportunities to accelerate new advances that will benefit kidney disease patients.
SIMPLIFIED: Using data to answer to the vitamin D question for dialysis patients
The SIMPLIFIED study is the first renal registry-facilitated trial of its kind.
Novel social media approach to recruit 40,000 volunteers with experience of depression or anxiety
The GLAD Study utilised social media as a vital tool for getting driving recruitment.
ROCOCO: Real-world research in a pharmacy setting
The real-world approach adopted by the Rococo study meant that it was the first cough medicine study in the UK to be delivered entirely in a pharmacy setting
Podcast series looking at complex and innovative trial design and delivery
These short podcasts inform, educate and answer the common questions around the management and delivery of CID trials. They are presented by a range of experts inclufing experienced researchers, patients, ethic committee members and more. Both series have been created in collaboration with the Health Research Authority.
- Transcript of podcast 1 - Emma Lowe - Discusses the definition of complex and innovative trials
- Transcript of podcast 9 - The development of the consensus statement for the design and conduct of CID Trials with Sarah Blagden
- Transcript of podcast 10 - Defining, Designing and Analysing CID Trials with Catey Bunce
- Transcript of podcast 11 - Defining a Platform trial and the advantages of using a platform trial design with David Seabag Montefiore
Listen to Complex and Innovative Design Trials podcast series two: Perspectives from the pandemic (2021)
Transcripts are available on SoundCloud once you have accesed a specific podcast.
- Emma Lowe explains the importance and impact of innovation in clinical research during the COVID-19 pandemic
- Professor Matt Sydes discusses the importance of communicating trial results to the study participants
- Professor Sir Munir Pirmohamed describes the NHS as the UK's "not so secret weapon" in delivering COVID-19 research
- Dr Hugh Davies talks about how the pandemic and clinical experience can be a new preface to clinical research
- Dr Emma Gray explains the development of the Muliti-Arm, Multi-Stage (MAMS) design trial ‘Octopus’ for people with progressive Multiple Sclerosis (MS)
- Professor Tim Maughan reveals lessons from running the adaptive FOCUS 4 trial
- Professor Thomas Jaki discusses the AGILE initiative and the advantages and challenges of platform trials
- Professor Pam Kearns talks about the CATALYST trial: Accelerating drug development for COVID-19
- Dr Camille Carroll explains the role of digital technology in clinical trials
- Kirsty Wydenbach provides the regulators perspective complex deign trials, and how COVID-19 has impacted the MHRA ways of working
- Yan Yiannakou talks about running a wholly virtual trial during the COVID-19 pandemic.