These podcasts aim to inform, educate and answer the common questions around the management and delivery of complex and innovative design (CID) trials. They are presented by a range of experts including experienced researchers, patients, ethic committee members and more. To find out more about how the NIHR supports complex and innovative design trials, visit the NIHR website: www.nihr.ac.uk/innovative-trial
Clinicians in conversation podcast series (2021/2022)
CLARITY IBD: Pragmatic pointers from a trial delivered in a pandemic
Professor Tariq Iqbal, NIHR National Specialty Lead for Gastroenterology and Dr Tariq Ahmad, Consultant Gastroenterologist and Chief Investigator of CLARITY IBD
Professor Tariq Iqbal talks to PDr Tariq Ahmad about CLARITY IBD, the most important gastroenterology study undertaken during the recent COVID pandemic.
In this episode they discuss how this pragmatic trial adopted an agile approach to rapidly answer a key question: Do common immunosuppressants used to treat Inflammatory Bowel Disease (IBD) reduce the effectiveness of COVID19 vaccines? They also explain how this study, which involves almost 7,000 participants from 92 UK hospitals, was set up and recruited to at an unprecedented speed.
- Listen to the CLARITY IBD trial podcast
- Transcript of the CLARITY IBD trial podcast
- Read a case study article about CLARITY IBD
Clinicians in Conversation INTEGRATE UK: Harnessing the power of the UK collaborative research culture
In this episode you will hear from the national trainee leads for Ear, Nore and Throat (ENT); Jameel Muzzaffar, Rishi Mandavia and Matthew Smith - who is also the co-founder of the INTEGRATE UK Trainee Network. They explain how using an innovative and efficient way of working, devised in the UK, they are able to help answer key research questions in ENT with minimal resources. They showcase the SEASHELL study a national multi-center cohort study of patients with sudden onset central hearing loss in the NHS which as recruited over 650 patients at 75 sites with very little funding.
They also about how the NIHR and the INTEGRATE network provides opportunities for trainees to gain vaulable experience in delivering and coordinating clinical research and helps to develop the next generation of ENT researchers.
Perspectives from the pandemic (2021)
Accessible transcript for podcast: How the COVID-19 pandemic broke the innovation pain barrier.
The complexities of communicating results to Complex Innovative Design (CID) trial participants - Professor Matt SydesIf a multi-arm platform trial answers more than one research question, should ALL participants hear about ALL the findings? Or just the findings from the arm they participated in? Matt Sydes, Professor of Clinical Trials and Methodology at the Medical Research Council (MRC) Clinical Trials Unit at University College London, draws on his experiences of the world-renowned STAMPEDE trial to offer some guidance.
Accessible transcript for podcast: The complexities of communicating results to #Complex Innovative Design (CID) trial participants.
NHS: the UK's not so secret weapon against COVID-19 - Professor Sir Munir Pirmohamed
Professor Sir Munir Pirmohamed talks to Professor Allan Gaw about how the UK was able to rapidly adapt to the quest to find new treatments for COVID-19. He points to key ingredients such as the NIHR research workforce, fast-tracked funding decisions, reduced bureaucracy, collaborative research culture - all of which contributed to the UK's success. Importantly, he also recognises that none of this could have been possible without the infrastructure and data systems provided by the NHS and he explains how the UK's integrated health research system was critical to the delivery of the hugely successful COVID-19 platform trials.
Accessible transcript for podcast:NHS: the UK's not so secret weapon against COVID-19.
Why the pandemic provides us with a preface to future research - Dr Hugh Davies
Dr Hugh Davies talks to Professor Allan Gaw about how research ethics approval services adpated during the pandemic to rapidly approve urgent public health research applications. As well as pointing to practical shifts, such as the switch from fewer face to face meetings to more frequent Zoom meetings, Dr Davies also describes a change of mindset. He describes how ethics panels had to revisit how they assess the benefit and risk balance when considering the burden of delivering research in a pandemic situation, against the desperate need to generate clinical evidence for what treatments work, and don't work.
Accessible transcript for podcast: Why the pandemic provides us with a preface to future research.
Octopus: Growing the armoury of MS treatments - Dr Emma GrayDr Emma Gray talks to Professor Allan Gaw about the clinical trial platform for Multiple Sclerosis studies, known as 'Octopus'.She explains how the Multi-Arm, Multi-Stage (MAMs) platform trial design will help to speed up the development of novel or repurposed treatments for MS that can slow neurodegeneration and/or protect nerves from further damage (neuroprotective). She also explains how the research team looked to the STAMPEDE prostate cancer trial for inspiration, and how cross-sector collaboration with the NIHR, the life sciences industry and charities was crucial.
Accessible transcript for podcast: Octopus: Growing the armoury of MS treatments.
Lessons learned from a flagship platform trial: FOCUS4 - Professor Tim MaughanProfessor Tim Maughan talks to Professor Allan Gaw about lessons learnt from delivering the world-renowned, molecularly stratified FOCUS4 platform trial He explains how this flagship trial was designed to respond to a need for a systematic approach to quickly understand which emerging, innovative cancer treatments worked against which cancers. He also describes why one of the biggest challenges was engaging life science companies. Finally he points to how this, and other ground-breaking cancer platform trials, have paved the way for COVID19 platform trials like RECOVERY which have saved thousands of lives around the globe.
Accessible transcript for podcast: Lessons learned from a flagship platform trial: FOCUS4.
The AGILE initiative: Influencing future treatment development - Professor Thomas Jaki
Thomas Jaki, Professor in Statistics at Lancaster University, talks to Professor Allan Gaw about the AGILE platform trial which specifically looks at novel (new) treatments for COVID19, as opposed to repurposed treatments. Professor Jaki describes how the efficient platform approach enables investigating treatment benefit (efficacy) and dosage in parallel and explains why AGILE is a stellar example of cross-sector collaboration. He also looks to the future: "we're hoping that the learning from AGILE is going to lead to a much better, much faster, setting up of studies and a much more efficient way to undertake treatment development in the future."
Accessible transcript for podcast: The AGILE initiative: Influencing future treatment development.
Harnessing the power of digital technology in clinical trials - Dr Camille Carroll
Dr Camille Carroll talks to Professor Allan Gaw about harnessing the power of the technology in clinical trials. She describes some of the advantages of using innovative digital technologies by highlighting some of the disadvantages and challenges faced when using traditional trial assessment methods. Zooming in on wearable sensor technologies, Dr Carroll also explains the concept of ecological validity and how these innovations can help researchers to overcome obstacles such as bias, recall error and human error to achieve accurate and objective results.
Accessible transcript for podcast: Harnessing the power of digital technology in clinical trials.
CATALYST trial: Accelerating treatment development for COVID-19 - Professor Pam KearnsProfessor Pamela Kearns talks about CATAYLST; a phase 2 platform trial which was designed to rapidly identify potential COVID19 treatments during the pandemic. She explains how the adaptive design of the trial and the bayesian statistical approach were crucial to quickly acquire go/no go decisions on which drugs should be trialled in larger COVID19 trials like RECOVERY. She also recognises how the collaborative research culture in the UK, combined with the coordinated efforts of the UK research ecosystem, made the UK "a fantastic place to be able to find the best treatments for COVID-19."
Accessible transcript for podcast: CATALYST trial: Accelerating treatment development for COVID-19.
How to avoid the pitfalls when planning a platform trial: A regulators perspective - Kirsty Wydenbach, MHRA
MHRA's Kirsty Wydenbach talks about the different types of complex, innovative design trials (CID) which became more commonplace during the pandemic. She provides some practical advice for researchers and sponsors designing such trials and explains how they need to work with the MHRA to make their study happen. She highlights some potential pitfalls to be aware of, and emphasises the importance of planning, communication, transparency and clear objectives.
Accessible transcript for podcast: How to avoid the pitfalls when planning a platform trial: A regulators perspective.
The power of virtual trials: Overcoming geographical boundaries - Professor Yan Yiannakou
Professor Yan Yiannakou talks about Relieve IBS-D which was one of the one of the UK’s first fully virtual, intervention trials. He recounts why the trial transitioned from a site-based trial to a virtual version, pointing to geographical exclusion as the biggest barrier to recruitment, even with 28 sites open across the UK. The virtual trial generated overwhelming interest leading to rapid recruitment. However, Yan is quick to zoom in on the logistics delivering the trial, explaining why biggest challenge of the virtual approach was having the clinical and administrative capacity to screen and enroll eligible patients.
Accessible transcript for podcast: The power of virtual trials: Overcoming geographical boundaries.
Pre-pandemic perspectives (2020)
An introduction to complex and innovative clinical trials
Emma Lowe, Department of Health and Social Care
Emma Lowe talks to Professor Allan Gaw about the design and delivery of complex and innovative design clinical trials.
In this episode they discuss what the term 'complex innovative design' (or CID) means in relation to clinical research. Emma explains that it focuses on 'how the research is done' as opposed to 'why it is being done'. She also highlights some of the benefits of delivering research in new and innovative ways, compared to the traditional randomised controlled trial (RCT).
The Life Sciences Sector Deal published on 5 December 2018 sets out the Government’s commitment to consolidate the UK as a world-leader in delivering complex and innovative trials. In relation to this, Emma describes some of the activities undertaken by the NIHR to:
- showcase UK expertise in designing and delivering complex and innovative design trials and;
- promote understanding of complex and innovative design trials across the UK clinical research workforce.
How can Complex Innovative Design (CIDs) trials speed up the drug development pathway for immuno-oncology drugs?
Sarah Blagden, Associate Professor of Experimental Cancer Therapeutics at the University of Oxford
Sarah Blagden talks to Professor Allan Gaw about why she co-led a paper outlining 10 consensus statements offering guidance to the clinical research community on the design and conduct of Complex Innovative Design (CID) trials.
She explains how these types of trials can speed up the drug development pathway and help to clear the backlog of of immuno-oncology drugs that are waiting to be tested, enabling cutting edge treatments can be offered to patients sooner. Sarah also describes why she thinks the UK is ideally positioned to conduct CID studies.
Better data equals better research equals better health care
Catey Bunce, Medical statistician
Catey Bunce talks to Professor Allan Gaw about the challenges and opportunities presented by #ComplexInnovativeDesign trials from a statistician's perspective.
As these trials typically answer multiple research questions, Catey explains why statistician needs to think critically about how to navigate the study so that it answers the questions without increasing the chance of a falsely significant result or even a falsely non significant result.
The advantages of the adaptive platform trial design
David Seabag Montefiore, Professor of Clinical Oncology and Consultant Clinical Oncologist
Professor David Seabag Montefiore talks to Professor Allan Gaw about the advantages of the platform trial design.
He zooms in on the PLATO trial (PersonaLising Anal cancer radioTherapy dOse) explaining how a traditional approach would have required three separate clinical trial proposals, three separate applications, and three separate trials with three separate teams to manage them. In contrast, the platform approach enabled one research team to answer multiple research questions within one overarching trial platform.
Podcasts produced by the HRA
The NIHR collaborated with the Health Research Authority (HRA) to create the podcast series: Effective trial planning and design of Complex Innovative Design (CID) trials. Further podcasts are available on the HRA Soundcloud page:
- What is a Complex Innovative Design and why do them
With Professor Pam Kearns, Professor of Clinical Paediatric Oncology, Director of the Cancer Research UK Clinical Trials Unit and Institute of Genomic Sciences in Birmingham
- What is the role of the Data Monitoring Committee in CID trials
With Louise Brown
- Transparency and publication of finished arm data
Professor Pam Kearns, Professor of Clinical Paediatric Oncology, Director of the Cancer Research UK Clinical Trials Unit and Institute of Genomic Sciences in Birmingham
- What information is important to patients and their families
With Debbie Keatley, Patient Representative from the Independent Cancer Patients’ Voice
- What do REC members need to know about CID trials
With Stephanie Ellis, Chair of the Hampstead and Cambridge Central Ethics Committee
- How to write patient facing documents that make sense
With Stephanie Ellis, Chair of Hampstead and Cambridge Central Ethics Committee and Debbie Keatley, Patient Representative from the Independent Cancer Patients’ Voice
- Complex Innovative Design trials and HRA approval
With Will Navaie, Engagement Manager at the Health Research Authority