By Dr Iain Matheson (Medical Director at DWL)
The Clinical & Contract Research Association (CCRA) has in recent years held annual, highly informative, professional updates at the end of January in the elegant surroundings of the Royal Society of Medicine in London, supplemented in 2017 by an additional day entitled “The Landscape for CROs post Brexit”. With lockdown in force throughout the country, it was not possible to meet in person this year; nevertheless, on 28 January 2021, the CCRA organised a virtual meeting called “The Dawn of a New Era for UK Clinical Research”. The event, opened by Lord Bethell, Under Secretary of State at the Department of Health and Social Care, was chaired by Dr Virginia Acha, Associate Vice President, Global Regulatory Policy, Merck Sharp & Dohme. This blog entry has selected just some of the highlights from that day.
Dr Martin O’Kane, from the UK Medicines & Healthcare products Regulatory Agency (MHRA), gave a very interesting talk entitled “Learning from COVID-19 and Building Back Better”. He reviewed 2020, which had been a challenging year given the pandemic and also the preparations to exit the European Union at the end of the transition period.
COVID-19 as a catalyst for novel clinical trial designs
The MHRA has for some time been supportive of novel clinical trial designs and COVID-19 led to an increase in such clinical trial applications, e.g. RECOVERY, PRINCIPLE and REMAP-CAP. A dedicated team was set up to review COVID-19–related trials to allow expedited clinical trial review and offer an optional informal pre-assessment process prior to formal submission. It was found that all clinical trial applications for COVID-19–related trials required Expert Advisory Group Review. As there is already close liaison between MHRA, ethics committees and the Health Research Authority (HRA), this continued to work well for COVID trials. Dr O’Kane reported that the Clinical Trial Helpdesk at the MHRA had seen a 412% increase in emails compared with 2019. Technical queries relating to COVID trials were usually responded to within 24 hours of receipt.
Because of the pandemic, regulatory flexibilities that already existed but were seldom used came into play. Examples of these include home delivery of investigational medicinal product (IMP), remote visits (phone calls/video calls rather than face-to-face visits), local laboratory processing of samples rather than use of a central laboratory, remote monitoring, risk-adapted safety reporting and use of electronic rather than wet-ink signatures. These were important since trials that would otherwise have had to be stopped were able to continue, thereby maintaining the integrity of trials: patients did not have to travel to study sites; trial conduct became more “patient-centric”, in other words, the trial was brought to the patient, not the other way round. Patients have responded positively to these changes (e.g. they now no longer have to take time off work to attend a trial site and have found trial participation a lot easier).
Interestingly, these new flexibilities have also been reflected in our day-to-day work at DWL, where we have had to translate texts about, for example, the delivery of IMP to the patient’s home or arrangements being made for remote instead of on-site trial visits.Dr Iain Matheson, Medical Director at DWL
The lessons from 2020 are to build resilience into clinical trial designs: be prepared (update standard operating procedures [SOPs], train staff) and build flexibility into protocols (regarding visits, monitoring, follow-up).
Yvette Cleland, CEO of Cpl Life Sciences, addressed the skills shortage in life sciences in the UK. The life sciences industry is very buoyant: it employs over 240,000 people across nearly 6000 businesses and generates turnover in excess of £73.8 billion. The UK currently leads Europe in the number of early-phase trials and phase II trials and ranks third behind Germany and Spain for phase III trials. Globally, the UK occupies fourth place in terms of phase III trials. The improvement in the UK’s performance in phase III trials will significantly benefit patients by making potentially life-saving therapies available to them.
However, the sector faces a skills shortage for several reasons. They include, among others, the fact that large pharma no longer trains the volume of talent it once did; the increase in outsourcing has impacted skills training; the 2008 economic crash meant that Learning & Development (L&D) departments were either downsized or got rid of and the loss of these along with the growth in contract workers have compounded the problem of skills erosion; Contract Research Organisations (CROs) were not set up in sufficient number to develop the required amount of new talent.
The future landscape therefore needs to optimise the processes for setting up and running clinical trials and building a workforce fit for the future with opportunities for all to be involved in research.
It will also be important to harness the UK’s health data to support the efficient design, recruitment and conduct of the full range of clinical trials. Yvette Cleland specifically referred to the role of clinical research apprenticeships. In general, the clinical research sector has been slow to capitalise on the possibility of apprenticeships (and it has to be remembered that in 2017 the UK government announced 3 million apprenticeships by 2020, so far there have been just over 740,000 apprenticeships, meaning a lot of the funds set aside for these—£2.8 billion—have not be used). The clinical research sector needs to make more use of this in order to have the people available with the necessary skills to manage the trials of the future. Importantly, the apprenticeships are also available to mature staff allowing them to acquire new skills.
These issues were also taken up in the talks by Emma Lowe (Acting Head of Research Policy: Clinical Research and Growth, Department of Health and Social Care) and Paul Blakeley (Head of Access to Innovation, Office for Life Sciences). The UK is especially strong in research delivery for high-end new treatments such as cell and gene therapies, where it delivers 12% of total global trials. Covid has highlighted the country’s strengths in clinical trials delivery. However, the global market is becoming increasingly competitive. In particular, China’s clinical research environment is continuing to grow across all trial phases.
On top of that, patients are, rightly, becoming more demanding, and more needs to be done to increase opportunities for patient participation and improve access to clinical trials for all who wish to take part in them.
Paul Blakeley highlighted the barriers that need to be overcome to stop research in the UK being delayed or prevented. Examples include: eliminating delays and variation in trust approvals of trials; reducing dependence on hospital site visits to conduct research and collect trial data.
This would make it easier for subjects to take part; maximising the potential of electronic healthcare data and of the UK’s national health and care infrastructure, along with the skills and capabilities of the workforce.
Other speakers on the day included Professor Atholl Johnston (CCRA President), Dr Camilla Fleetcroft (Interim Group Manager, MHRA), Dr Matthew Hallsworth (Head of External Relations, NOCRI), Janet Messer (Director of Approvals Service, HRA), Dr William van’t Hoff (CEO, NIHR)
For the full programme, please visit the official website of the CCRA.
We look forward to future updates about the landscape of UK Clinical Research from the CCRA.