September 29, 2021

expert reaction to ABPI report on the clinical trials environment and the impact of the pandemic

The Association of the British Pharmaceutical Industry (ABPI) have published a report on clinical research in the UK.

Prof Sir Martin Landray, Professor of Medicine & Epidemiology, University of Oxford, and Co-lead RECOVERY trial, said:

“During COVID-19, we have seen the huge benefits that high quality clinical trials can bring to patients and public health.  We now have an opportunity to learn from that experience to improve the treatment of many other conditions that place burden on patients, their families, and the NHS.

“As is highlighted in this report from the ABPI, there is much to learn from the UK’s successful delivery of definitive clinical trials of treatments for COVID-19.  For example, the RECOVERY trial has provided clear evidence of the benefits of dexamethasone, the rheumatoid arthritis drug tocilizumab, and most recently the antiviral combination made by Regeneron (and marketed as Ronapreve).  These treatments have become standard of care for patients hospitalised with severe COVID not only in the UK but around the world, saving hundreds of thousands of lives.

“Particularly for later phase trials, i.e. those that will directly inform licensing decisions, changes in treatment guidelines, and improvements in patient care.  The key challenge is not ‘How do we do more trials?’ but ‘How can we do better trials?’ – trials that produce meaningful answers to important questions.  So while the ABPI summary of the number of trials conducted in the UK compared with elsewhere are informative, we need to look beyond the metrics.

“Over the past 2 decades, clinical trials have become increasingly challenging to conduct and burdensome for patients to participate in – large (phase 3) trials of treatments for common diseases such as diabetes and heart disease typically cost 0.5-1 million dollars.  This is important because it discourages the development of affordable medicines for conditions that place substantial burden on patients, their families and the NHS.

“Much of the experience of trials such as RECOVERY has been that things don’t need to be that way.  It is possible to design and conduct clinical trials that are embedded in clinical care, make effective use of routine NHS data to increase the quality of the trial results and minimise work for clinical staff, and which produce results that change clinical practice and improve public health.

“Many exceptional things happened to make this possible – we now need to turn the exceptional into sustainable business as usual.  We cannot afford for clinical trials to slip back to pre-pandemic practices.  The recommendations produced by ABPI are a good start – embedding clinical trials in routine healthcare, streamlining clinical trial approvals, diversifying patient recruitment and involvement, and adopting smart approaches to trial design and delivery (including the use of routine healthcare data).  Similar themes emerged from the G7 in June, with a particular emphasis on the need for better regulation – focusing on issues that matter (rather than what is easy to check but less relevant), placing an emphasis on principles and purpose rather than process, and embracing flexibility and innovation.”

Dr Allyah Abbas-Hanif, Incoming Chair of the Policy and Communication Group at the Faculty of Pharmaceutical Medicine, Member of the Paediatrics and Pregnancy Expert Group of the Faculty of Pharmaceutical Medicine, and Honorary Senior Clinical Lecturer at Imperial College London, said:

“This report is timely and highlights that despite a multitude of unprecedented challenges, including a global pandemic and Brexit, the UK is still an attractive and diverse platform for international clinical research.  To drive innovation, the UK must now pivot and prioritise diversified patient recruitment in clinical trials as well as continue to pioneer in cutting edge therapeutic areas.  As recommended, adopting innovative clinical trial design and streamlined access to regulatory input will allow marginalised and disproportionately affected groups access to Covid-19 and other research.  The UK, with the more dynamic MHRA at its helm can spearhead creativity in drug development for ethnic minorities, pregnant and postpartum women, children and other overlooked groups.  To do this government commitment to significant and sustained investment plus continued collaboration across the academic, biopharmaceutical and healthcare industries is required.”

Dr Doug Brown, Chief Executive of the British Society for Immunology, said:

“During the COVID pandemic, the UK research community has come together like never before to drive forward the clinical research agenda and deliver game-changing developments in our knowledge of COVID-19 biology to both prevent and treat this disease.  This innovation was evident throughout the medical spectrum, and particularly in immunology through nationwide initiatives such as the UK Coronavirus Immunology Consortium.  There are many lessons that we can now take from the research community’s response to the pandemic to develop agile, innovative and collaborative research approaches that will benefit other areas of medical science to tackle some of the greatest health challenges to humankind.

“The British Society for Immunology welcomes the publication of today’s report from the Association of the British Pharmaceutical Industry on clinical research in the UK.  Our own observations concur with the ABPI’s findings on the negative impact that the pandemic has had on non-COVID clinical research.  However, the report’s recommendations provide a pragmatic path to improve this situation, which we endorse.  The UK has the clinical expertise, research environment and infrastructure which allows us to be ambitious in developing a pioneering approach to clinical research.  To do this, we need to ensure we have significant research funding available and that the NHS is properly resourced to support a culture of clinical research.  This is ambitious but is eminently achievable and if we get this right, we have the potential to deliver life-changing benefits to patients.”

‘Clinical research in the UK: an opportunity for growth’ by the Association of the British Pharmaceutical Industry was published at 00:01 UK time on Wednesday 29 September 2021.

Declared interests

Prof Sir Martin Landray: “Co-lead of RECOVERY trial. Longstanding clinical trialist.”

Dr Allyah Abbas-Hanif: “I co-chair the ABPI maternal health group.

Incoming Chair of the Policy and Communication Group at the Faculty of Pharmaceutical Medicine.

Member of the Paediatrics and Pregnancy Expert Group of the Faculty of Pharmaceutical Medicine.

Honorary Senior Clinical Lecturer Imperial College London.

No conflicts to disclose.”

Dr Doug Brown: “Doug is a Trustee of the Association of Medical Research Charities.”