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The review by Lord O’Shaughnessy has been published as part of the package of announcements on life sciences growth in the UK.
Dr Flic Gabbay, President of the Faculty of Pharmaceutical Medicine, said:
“Yesterday’s announcements of further investment into life sciences by the UK Government is welcomed by the Faculty of Pharmaceutical Medicine (FPM). Commercial clinical trials in the UK: the Lord O’Shaughnessy review – final report was also released this morning. Members of FPM gave evidence to this and other reports, also making recommendations used in the UK Government life sciences package.
“The O’Shaughnessy review addresses many challenging aspects of clinical trials, and in response the UK Government has committed to making it easier for innovative healthcare products to get to patients by cutting the regulatory burden of approving clinical trials. UK Government has committed £121 million, made up of new and existing funding, to speed up clinical trials and improve access to real-time data via new Clinical Trial Acceleration Networks.
“The investment is intended to make UK an attractive destination for industry sponsored clinical trials, with regulatory reform and improved access to data, supporting access to innovative treatments for patients. Implementing the recommendation’s proposals, alongside these other announcements, will be welcomed by the many pharmaceutical physicians leading research programmes in pharmaceutical companies and academia and crucially those involved in regulating and managing access to new medicines.
“The FPM Clinical Trial Science and Regulations Expert Group will be reviewing and commenting on more detail in the reports and package in the coming days. The group will also be considering the implications and opportunities for international collaboration.”
Prof Alejandro Frangi, Diamond Jubilee Chair in Computational Medicine and Royal Academy of Engineering Chair in Emerging Technology at the University of Leeds, said:
Is this review based on good evidence?
“The Report has taken a consultative approach and hence represents a solid consensus across sectors and actors in the UK. This is a massive step as it emerges from an emergent realisation that the current status quo is suboptimal and unsustainable for healthcare and the economy.
Do you agree with the recommendations?
“These recommendations are a magnificent contribution to delivering the Life Sciences Vision. When fully implemented, they will represent a substantial step-up to bring back and boost commercial clinical trial activities in the UK. This is crucial if our NHS is to count on solid scientific evidence based on UK demographics on the safety and efficacy of various innovative therapeutic options. Most recommendations will represent an important advancement even if they can be seen as actions to “simply put the house and bookkeeping in order”. For the average citizen in the digital age, realising that the wealth of data collected about their health (today) cannot easily be accessible and integrated to understand better the impact of products or healthcare decisions on the population could be shocking. However, this is where indeed we need to start. I wished the Report would have gone beyond and embraced other approaches to generating scientific evidence, like computational modelling and simulation (aka in silico methods -> www.insilicouk.org), that can complement real-world evidence and go beyond. I am also somewhat concerned that this report reflects once more the important but narrow lens of pharma. The UK has historically been a pioneer in medical devices – implants and imaging, which have their own challenges. We have several thousands of innovative medical device companies in the UK 90% of which are SMEs and provide highly skilled jobs. To what extent the recommendations will address their needs is still unclear but essential to our economy (https://www.uk-cpi.com/news/one-in-five-uk-healthtech-smes-head-to-us-for-product-launch).
What did we learn about how to do clinical trials well during the pandemic?
“To me the most important lesson is that we need to shake up the way we do things; and that when we do this with purpose and clarity of goals, we can achieve similar goals or better than when doing things in the currently lengthy and unsustainable way. It also showed that while the UK has regulatory science and innovation capabilities, this is not necessarily in the current system of regulators but in academia. The challenge is capitalising these learnings so we are caught more prepared.
What are the implications in the real world? Is there any overspeculation?
“I do not think there are overspeculations. If anything, I feel the report is cautious and pragmatic. I believe the proposed clinical trial acceleration networks (CTANs) will be a very important component of future preparedness.”
Prof Sir Martin Landray, Professor of Medicine and Epidemiology, University of Oxford, said:
Context:
“Lord O’Shaughnessy’s review and the government’s response to it, recognise three key facts:
“The UK has many structural advantages but suffers badly from self-inflicted complexity, bureaucracy and procrastination with a substantial burden of well-intended but poorly articulated and executed regulatory and governance processes. Whilst frontline clinicians are keen to get involved in clinical trials and to help find better ways to treat patients, they are wary of yet more unnecessary paperwork and struggle with the lack of dedicated time in their job plan.
Scale of ambition:
“We must recognise, that in purely commercial terms, the UK is a small fraction of the global pharmaceutical market, sitting on the doorstep between the much bigger US and EU markets. Therefore it is not sufficient for us to be merely as good at doing clinical trials as our neighbours – we must be substantially better.
“At present the UK contributes just 2% of global recruitment into clinical trials, comparing poorly with countries such as Germany and Poland each recruit double that proportion.
“Here I would be more ambitious than Lord O’Shaughnessy:
“Indeed, the NHS Galleri trial of a novel test for early detection of cancer enrolled over 140,000 patients within the last year and the ORION-4 trial of inclisiran has recruited over 80% of the global target of 15,000 patients in the UK.
Reflections on the recommendations:
“Lord O’Shaughnessy’s report is helpful and timely. The government’s immediate response is an important step in the right direction – although time will tell whether those initial promises are seen through to completion and whether the many other important recommendations and details in Lord O’Shaughnessy’s report are effectively enacted.
“Some changes could, with the right willpower be enacted very fast. Some require funding (and today’s announcements provide a good start on that). But just as important will be to identify the things we should stop doing, the obstacles and processes that add little value but substantial costs in terms of time, money and motivation. An update on implementation is promised in the autumn. It would be good to see progress, not only on the current commitments but across the wider report by then.
“Government will not be able to do this alone and must not try. The key task for the UK health research establishment is to optimise the processes which support the timely, coordinated, proportionate and scalable conduct of clinical trials but which leave space for innovation – both in trial design & delivery and in the types of health intervention & settings in which they are studied – for others. There is a wealth of experience and expertise willing to contribute and huge opportunities for the UK economy, the life sciences sector, sustainable healthcare and patient health both in the UK and globally.
More detailed comments on government response:
“Lord O’Shaughnessy’s review makes 27 recommendations and proposes improvements in many more areas within the detailed text. The government has picked up on 5 of these and made positive immediate responses:
1. Substantially reduce the time taken for approval
“Together with the need to simplify NHS contracting (see below), this is the commonest complaint from those trying to establish clinical trials in the UK. We already have one huge advantage – the ethics committee system, whereby one approval covers the entire UK, is working well under the auspices of the Health Research Authority. But the MHRA review process is in a poor state.
“It will be critical to improve not only the capacity (the number of people) in the MHRA but to increase its access to the level of experience and skills it needs, much of which is outside its walls.
“A good start would be to adopt the Principles of Good Randomized Trials (www.goodtrials.org) co-developed by the very broad-based Good Clinical Trials Collaborative, a recommendation made in Lord O’Shaughnessy’s report and in the G7 100 Days Mission. A similar, outward-looking approach would improve the quality of the MHRA’s inspection system, an area where the UK falls well behind the US Food and Drug Administration.
2. Deliver a comprehensive and mandatory national approach to NHS contracting
“This is a widespread and long-term source of frustration – one ethics approval and one MHRA approval covers the entire UK, but each NHS organisation reviews, negotiates and approves its own contract often going through layers upon layers of internal governance processes. This makes no sense, adds little value, causes delays and ultimately reduces opportunities for participation in clinical trials. A great example of a single-payer, single-logo, multi-bureaucrat paradox.
“The proposal that contracting be agreed with one, lead site on behalf of the whole NHS sense make good sense. There may be further actions needed to ensure that liabilities and risks are appropriately apportioned and that individual sites adhere to the approach without then creating a new set of processes.
3. Provide ‘real-time’ data on commercial clinical trial activity in the UK
“There is little doubt that the quality and method by which data on clinical trial activity is collected and reported in the UK needs radical improvement. There are dangers if it is not done well: Over the last few years, I have heard increasing numbers of complaints that NHS clinical research, staff are having to spend so much time filling in logs and reports about how many patients they have recruited into a studies that they are not able to see patients and recruit them into studies.
“To be useful, it is critical that data on clinical trial activity is collected in a way that is timely, accurate, well analysed and transparent, but avoids, adding burden or distraction from getting on with the job of doing the research.
4. Establish a common approach to contacting patients about research
“The proposal that the Health Research Authority work closely with other government, NHS, and regulatory organisations to streamline the process by which patients can be approached about the search is welcomed. HRA are well-positioned to lead here and need to be adequately resourced to do so. This not a new area though: For example, for the NHS-Galleri trial of early cancer detection, NHS DigiTrials generated invitation letters to suitable participants in much the same way as its predecessors enabled the recruitment of over 12,000 patients into the ORION-4 trial of inclisiran and tens of thousands of people into a succession of similar cardiovascular trials over the past 3 decades.
5. Establish clinical trial acceleration networks (CTANs)
“Lord O’Shaughnessy’s report calls for Clinical Trial Acceleration Networks to be commissioned to provide joint leadership between industry, NHS, academic and medical research charities; focus on a field that has high unmet need, addresses a large market or is otherwise globally significant in its potential; aligns to the strategic interests of the UK; and would be capable of delivering a significant and growing level of clinical trial activity over time.
“Here there appears to be a disconnect between Lord O’Shaughnessy’s recommendation to commission 8-10 of these during 2023 and the government’s response which is to establish just 2-3 of these over a longer period of 2 years. It is unclear whether discrepancy is driven by funding considerations or by resistance within some part of the existing government research system to the idea that the delivery of innovative, efficient and effective approaches for clinical trials could be provided by others.
“It will be important that the process and decision-making for commissioning these is driven by people and processes with experience of facilitating and supporting innovation (not a typical feature of many conventional funding agencies). There is a whole economics literature about why big organisations can’t innovate and a reason why alternative funding approaches such as ARPA-H in the United States were set up and the success of the Vaccines Taskforce in making funding decisions at-risk is well documented.”
Prof Nikola Sprigg, Professor of Stroke Medicine, Stroke Trials Unit, University of Nottingham, said:
“The review is excellent and highlights the vital importance of research and suggests achievable steps to help us tackle the current barriers.
“Doctors, nurses and clinicians want to deliver and take part in research, patients want to have access to new treatments – but multiple delays, barriers and risk adverse complexities often make it impossible.
“The government response is a start but unfortunately does not go far enough. Research needs to be an integral part of the NHS – rather than an additional optional extra… for staff and patients.”
Dr Melanie Lee, LifeArc CEO, said:
“As an organisation that helps turn scientific ideas into medical breakthroughs for patients, LifeArc have been concerned by some of the hurdles being faced and the recent drop in UK clinical trial activity. We have heard from both patients and clinical professionals that they would embrace more opportunities to participate in clinical research.
“It is encouraging that this review, and the Government’s response, acknowledges many of these challenges and the steps needed to overcome them. Transforming this landscape is crucial for both patients and the UK’s health system, science base, and economy. It is needed to keep the UK at the forefront of knowledge, developing new therapies and ensuring patients get broader access to new treatments.
“We are particularly pleased to see suggestions on how the NHS can best embed clinical research and how the use of clinical data can be maximised. Improvements here could be transformational in areas such as medicines repurposing and personalised medicine, which are a core part of our strategy.
“We look forward to working with the Government and the wider community to turn this plan into a reality and to seeing the difference it can make for the life science community and patients.”
Prof Nick James, Prostate and Bladder Cancer Research Team Leader, Deputy Dean (Clinical Studies), Institute of Cancer Research, and NIHR Senior Investigator, said:
“Lord O’Shaughnessy has accurately identified both the problems and the fact that other countries, faced with the same issues such as Covid-19 have improved faster than us. We are becoming increasingly uncompetitive internationally. The successes of the pandemic have not translated into benefits post pandemic – quite the opposite, trials structures have been left under-funded, deprioritised and dysfunctional.
“The proposed solutions are comprehensive and relate to the excessive UK bureaucracy, chronic issues with NHS R&D departments, fragmented approval processes and lack of prioritisation in the NHS.
“The report identifies clear benefits both financial and clinical from wider participation in trials. This should provide an engine for change as it should be revenue generating.
“The report provides clear solutions with best practice examples, it is in everyone’s interests that these are properly resourced and implemented swiftly.
“In conclusion, this is a timely and excellent report with clear recommended action points. If the ongoing slide of the UK in the clinical trial arena is to be halted, the Government needs to act on it urgently.”
Paul Schreier, Interim Chief Executive, Wellcome, said:
“The O’Shaugnessy review of the clinical trials’ environment is a very good piece of work in an area where the U.K. has both a strong history, and much potential for the future. We welcome it, and the government’s commitment to its implementation, for which there is not a moment to be lost.”
Dr Jenny Rivers, Acting Director of Research and Innovation at Great Ormond Street Hospital said:
“We welcome this report and the spotlight it shines on challenges and opportunities for driving clinical research in a setting as complex as the NHS. We believe that Lord O’Shaughnessy could have gone further in acknowledging the extreme pressure the UK healthcare system is under and we would welcome further support to tackle NHS capacity more broadly than doctors and nurses, but to wider healthcare professionals, research delivery staff and the R&D workforce.
“While we recognise the use of metrics as a useful tool for measurement, they can be a blunt instrument when it comes to research and that we should exercise caution when extrapolating patient impact from recruitment numbers, or approval times – especially in rare and complex diseases. For example, at GOSH we focus on opening trials as soon as we can and sometimes this means we must wait for the right patient. This might appear as a long delay in the data, but really it just ensures we are ready for that child when they are in need. We are also encouraged to see that the report urges us not to prioritise commercial trials at the detriment of academic studies, though this will be a challenge and we will need to think through how we achieve the right balance to meet patient needs in the immediate and longer term.
“We very much see the report, and the Government response, as an early step in a journey we have already begun. We agree that further investment is required to achieve this and we look forward to ongoing discussions across the sector to determine how this will be deployed for most impact to the UK Life Science Sector. We have seen improvements in research delivery since 2020, but it’s encouraging to see the focus on a better use of clinical data and the value that lies within it. To this end, we have recently launched a partnership with Roche Pharmaceuticals to explore the type of data we collect, what we could be doing better to improve efficiency, advance robust research and, crucially, lead to stronger impact across healthcare, wherever that may be.”
Prof Dame Anne Johnson PMedSci, President of the Academy of Medical Sciences, said:
“The UK is renowned for having a strong life sciences sector that delivers significant health and economic benefits through world-leading, life-saving research. For this to continue, the UK must be internationally competitive and an attractive destination for world-class talent, investment and innovation, which is why we welcome the substantial support package announced by Government.
“Among the measures and funding news, we are pleased that the UK Biobank has been recognised as a national asset to generate new discoveries that benefit patients and leverage new partnerships and investment from across the health research system.
“The Lord O’Shaughnessy review into commercial clinical trials in the UK, also published today, highlights that our strength in life sciences is intimately linked with the excellence of the UK health research system, from universities to charities. It rightly points out that the NHS is a critical part of this system and therefore must be an active and engaged partner to our life sciences industry as well as our academic and charitable sectors. It is positive to see that the report also highlights the importance of patient involvement and the need for the NHS workforce to be able to engage in research.
“These findings, along with the commitments made to ensure regulation is fit for purpose, align strongly with our recently published report on future-proofing UK health research. This set out some of the steps needed by Governments, funders, universities, industry and the NHS to deliver on the ambitions that are reflected in the announcements. We look forward to working with partners across sectors to realise the full potential of the UK’s life sciences sector in driving economic growth and improving public health.”
Associate Prof Marion Mafham, A Research Director at Health Data Research UK and the University of Oxford, said:
“The focus on improving the landscape for carrying out clinical trials in the UK in the O’Shaughnessy review is excellent news.
“Randomised controlled trials are essential to reliably assess the effects of medicines, surgery and other healthcare interventions to treat or prevent disease. Patients stand to benefit from access to new and better treatments more rapidly.
“To reliably detect effects on important but uncommon health outcomes (for example, on heart attack or cancer recurrence), randomised trials need to be sufficiently large so researchers have enough data to get a reliable answer – often requiring several thousands of participants over many years.
“Some randomised trials have become so complex and costly to run that their very existence is under threat. The clinical trial costs of developing new treatments are currently estimated to be $500 million to $3 billion, encouraging the pharmaceutical industry to focus only on developing high-income drugs.
“As the O’Shaughnessy review points out, it is possible to make the clinical trials process more efficient and effective, and to make the UK a more attractive place for pharma to carry out its trials. I’m particularly pleased to see support for the safe use of data already collected in the NHS to identify and invite patients to join clinical trials relevant to them, and for researchers to be able to analyse health outcomes for patients in trials without having to collect and check the data by hand.
“This could potentially transform clinical trials – enabling more UK patients to take part in research studies and producing robust results which improve care.”
Richard Torbett, Chief Executive, Association of the British Pharmaceutical Industry (ABPI), said:
“Today’s announcements show that the government recognises the huge opportunity waiting to be grasped if the UK can unlock the economic potential of its life science industry – already worth £94.2bn in 2021. These measures demonstrate the government has listened to industry and will help put the UK on track to meeting its life science vision.
“Lord O’Shaughnessy is right that making the UK an attractive destination for industry clinical trials requires regulatory reform, speedier study set-up and approvals, and improved access to data. Implementing his proposals, alongside these other announcements, can be a springboard to delivering on the UK’s ambition to be a science superpower, and we now must press forward with delivery at pace.
“However, improving research is only one part of the equation. To get innovative medicines to patients and fully capture the growth opportunity, we must also fix the commercial environment, and for that, we also look forward to agreeing with Government to a new and improved Voluntary Scheme as soon as possible.”
Nicola Perrin MBE CEO of the Association of Medical Research Charities (AMRC), said:
“This is an important and wide-ranging review with the potential to help transform clinical trials in the UK. The system has been struggling and these timely recommendations have the potential to really change things to give better access for patients both to new research and innovative treatments.
“These recommendations are incredibly welcome, as is the announcement of funding to deliver new clinical trial acceleration networks. We are also pleased to see the Government prioritise the need to provide real-time data on clinical activity. Monitoring the full trial portfolio will ensure early phase clinical trials and academic clinical research are not destabilised by the focus on incentivising commercial trials.
“The proposal to update legislation to make clinical research part of direct care is potentially an exciting way to ensure all patients can benefit from the opportunities of taking part in clinical trials and we look forward to seeing further details.
“We thank Lord O’Shaughnessy for recognising the vital role of charities in raising awareness of research and helping recruitment for trials and look forward to supporting the NHS in this work.”
Prof Anthony Gordon, Chair in Anaesthesia and Critical Care, Imperial College London, said:
“Clinical trials are vital to improve healthcare and we need both commercial and academic-led trials to achieve maximal benefit. This review makes important recommendations that focus on commercial trials but if these recommendations are implemented, they should facilitate all clinical trial activity in the UK.
“Providing resources for clinical staff to deliver trials, making important governance processes streamlined and ensuring safe ways to share data are all vital to delivering clinical research. We saw during the COVID-19 pandemic, when resourced appropriately and with unnecessary bureaucracy removed, just how quickly the NHS was able to deliver high quality clinical trials that improved care for patients in the UK and worldwide. We now need the willingness and resources made available to allow clinicians, industry and academics to work together, to embed clinical trials into the everyday activity of the whole NHS, so that all patients and all areas of health can benefit.”
Dr Samantha Walker, Director of Research and Innovation at Asthma + Lung UK, said:
“I’m pleased Lord O’Shaughnessy’s review highlights the areas where clinical trials aren’t currently working in the UK and that the government proposes to accept his recommendations. Clinical trials are an essential part of developing new and better treatments for people. However, without a consistent way to connect people in need of treatment with the appropriate trial, the system supporting clinical research in the UK breaks down and faces collapse. This undermines the UK’s ambition to be a science superpower.
“Of particular interest to the charity in the review is the recommendation to promote research to the public. When clinical trials struggle to recruit, it becomes harder to conduct research and attract funding. In addition to this, people lose access to pioneering treatments that could transform their lives. In the UK lung conditions are the third biggest killer, we look forward to working with the government, the NHS and industry to find ways to increase clinical trial recruitment and to give people with lung conditions access to lifesaving clinical lung research.”
Prof Charlotte Summers, Professor of Intensive Care Medicine, University of Cambridge, said:
“The O’Shaughnessy review has captured many of the issues contributing to the decline in commercial clinical trial activity within the UK, and the government’s commitment to implement the proposed recommendations is to be welcomed. If we are to become a science superpower, it is vital that we use this as opportunity to expand clinical trial activity in the UK, and that we do not implement these reforms in a manner that leads to decreased non-commercial research activity – our patients need both.”
Prof Andrew Morris, Director of Health Data Research UK, said:
“The government’s set of announcements to support the life sciences in this country is welcome. The investment in infrastructure, the new public-private partnerships and the boost to research on mental health conditions are good news for the sector.
“But I believe that the two reviews announced today are just as important: the publication of Lord O’Shaughnessy’s recommendations to make it easier for clinical trials to be run in the UK and the review of regulatory systems in the life sciences led by Professor Dame Angela McLean.
“Figures from the pharmaceutical industry body the ABPI show that the number of industry clinical trials started in the UK each year fell by 41% between 2017 and 2021. We have fallen behind many other international countries in a short space of time. This is devastating for pharma in the UK and its impact on jobs and the economy, but more importantly for patients in the UK. Involvement in clinical trials tends to make it more likely that patients can access new and effective treatments more quickly. The recommendations in the O’Shaughnessy review point to ways forward to reverse this decline.
“The one missing thing in today’s announcements that would transform life science research in the UK is a positive conclusion to the talks for the UK to access the EU’s Horizon research programme. Research today is built on team science with collaborations across the globe. Working alongside other top scientists in Europe benefits everyone and keeps all our research at the cutting edge, speeding benefits for patients and the public.”
Darius Hughes, Moderna’s General Manager for the UK, said:
“Today’s announcement is a huge boost to UK life sciences and reinforces our excitement to be making a big investment in this country, delivering onshore manufacturing and R&D capabilities.
“We particularly welcome the recommendations in the Independent Review, all of which demonstrate a commitment to reinvigorate the UK’s world class reputation in clinical research that will bring benefits to patients, and we look forward to working with the government on its implementation.”
Steve Bates OBE, CEO of BIA, said:
“Running effective commercial clinical trials in the UK is a win for all involved. NHS patients who get access to novel therapies, the NHS which gets income and upskilled, engaged clinical teams, while the life science industry gets the valuable, timely data that companies need to progress products to global registration and market.
“This detailed report from Lord O’Shaughnessy demonstrates that we can do this and provides a sharp and detailed focus on what more needs to be done to ensure the UK wins much, much more of this sought-after work in the months and years ahead.
“Sir Patrick Vallance’s review of life sciences regulation provides sensible and tangible actions on how regulators can help rather than hinder the development and delivery of biology-based innovation, from innovative medicines to lab-grown meat. The UK has a competitive advantage in engineering biology, which will be crucial to delivering our net zero ambitions and countless other benefits for society and our economy, but we must create a supportive environment for small innovative companies developing these cutting-edge technologies. We urge the Government to move swiftly to implement Sir Patrick’s recommendations.”
Dr Ian Walker, Executive Director of Policy, Information and Communications at Cancer Research UK, said:
“The O’Shaughnessy Review has rightly recognised that the UK’s clinical trials system needs to change. The system has been under pressure for many years, but has been pushed close to breaking point by the pandemic and related pressures on the NHS.
“Many of the review’s recommendations recognise the value that medical charities like Cancer Research UK bring to clinical trials, offering patients early access to innovative new treatments. Taking trials to sites outside of hospitals and cutting red tape will help get more trials up and running, get more patients joining trials and make faster progress towards new treatments.
“But fundamentally we must urgently address the lack of time and capacity available for research within the NHS. Right now, staff within cancer services are overstretched, struggling to set aside time to deliver promising clinical trials which could ultimately make smarter use of the NHS.
“If the UK doesn’t address this core problem now, it will lose the chance to lead globally renowned clinical trials in the future as trial sponsors look to other countries with better infrastructure already in place. The UK Government needs to urgently deliver a programme which offers contracts with protected time for research to key NHS staff, to give them the time and space needed to get trials back on track. More broadly, we need a fully funded strategy to recruit, train and retain the staff we need to ensure cancer services are fit for the future.”
Prof Sir Rory Collins, Principal Investigator and CEO of UK Biobank, said:
On the Life Sciences moment:
“Today’s announcements highlight the UK’s potential to transform our health, knowledge and economy by cranking up our science. One key way to do that is to bring all NHS data into one place.
“During the pandemic, the Secretary of State enabled medical records to be shared for public health research. The insights were enormous and will have saved lives, but this data has now been locked away in silos once more.
“At UK Biobank we have 500,000 volunteer participants who altruistically signed up to share all their health-related data, but currently they cannot share the most useful data of all – the data controlled by their GP. Our aim is to honour our participants’ wishes, fix this, and have these data released for life-saving research.”
‘Commercial clinical trials in the UK: the Lord O’Shaughnessy review – final report’ was published at 22:30 UK time on Thursday 25 May 2023.
Declared interests
Prof Alejandro Frangi just got an ERC grant to further his research on AI “in-silico” clinical trials – https://www.leeds.ac.uk/news-technology/news/article/5284/pioneering-safer-cheaper-and-quicker-clinical-trials-with-ai-digital-twins
Prof Sir Martin Landray is Chief Executive of Protas, a non-profit organisation focussed on facilitating smarter randomised trials for common health conditions, and Professor of Medicine & Epidemiology at University of Oxford. He was appointed by Wellcome Trust and Bill & Melinda Gates Foundation to lead the Good Clinical Trials Collaborative. He co-leads the RECOVERY trial of treatments for patients hospitalised with COVID-19.
His work receives funding from the pharmaceutical industry, government, charitable and philanthropic organisations through grants to Oxford University and to Protas.
He has no personal financial interests in companies involved in the life sciences, alcohol, tobacco or health sectors.
Prof Nikola Sprigg: “I am a clinical academic – with research funding from charity and NIHR. Have taken part in academic and commercial research and recognise the problems in the report.”
Prof Nick James: “I receive funds to run commercial trials via various trials groups but not personal reimbursement for this. It’s my job to run trials so clearly I want them to be easier and faster!”
Prof Marion Mafham: “Lord James O’Shaughnessy, who led the independent review of the UK clinical trials landscape, is a board member of Health Data Research UK.
Declaration of interest:
I am employed by the Nuffield Department Of population Health, university Of Oxford
and funded by the Oxford BHF CRE;
– I have an Honorary contract with Oxford University Hospitals NHS Foundation Trust;
– I receive no honoraria or personal payments from industry in compliance with the
NDPH policy for maintaining scientific independence*;
– I am a co-applicant on research grants from The Medicines Company/Novartis and
NOVO Nordisk to the University Of Oxford, and work on projects funded by research
grants from, or supported in kind (supply Of study medication) by, Abbott, AbbVie,
Bayer, Boehringer Ingelheim. Merke, Mylan, Roche, Regeneron and Solvay.
* https://www.ndph.ox.ac.uk/files/about/ndph-independence-of-research-policy-jun-20.pdf/@@download
Prof Anthony Gordon: “Professor Anthony Gordon is Chair of Anaesthesia and Critical Care at Imperial College London and an intensive care consultant working at St Mary’s Hospital, London. He is the UK Chief Investigator for the international REMAP-CAP trial (evaluating treatments for COVID-19 and influenza), the International co-Chief Investigator for AstraZeneca’s TILIA trial (evaluating tozorakimab for viral pneumonia) and is an NIHR Senior Investigator.”
Prof Charlotte Summers: “Chief Investigator of HEAL-COVID, and NIHR funded non-commercial UK-wide platform clinical trial.”
Prof Andrew Morris: “Lord James O’Shaughnessy, who led the independent review of the UK clinical trials landscape, is a board member of Health Data Research UK.”
For all other experts, no reply to our request for DOIs was received.