Navigating through the post-COVID-19 R&D bottleneck
Jack Goddard investigates how the COVID-19 pandemic has disrupted R&D, and how the changes it enforced may prevent such widespread disruption in the case of another pandemic
The world’s vaccination effort against COVID-19 is in full swing, slowly but surely bringing the nightmare of the last 16 months to a close. But as the smokescreen – of government briefings, vaccine rollouts, and countless COVID-related deaths – begins to dissipate, the world is now facing problems that could remain years after the last lifted lockdown.
For a start, analysis of recent NHS England data has shown a 16% drop in urgent cancer referrals between March 2020 and January this year. As a result, 350,000 cancer patients in the UK have not been referred for treatment, causing thousands more potentially fatal cases. The shortfall in diagnoses is concerning to the extent that it may cause a decrease in survival rate for the first time in decades.
Clinical Research Delivery
The disruption COVID-19 has caused to research and development (R&D) in the pharmaceutical industry will have implications for future healthcare too, with much of the last 16 months lost due to a refocusing of research, the movement of staff to the NHS frontline, and restrictions that made clinical trials and lab work almost impossible.
Pharmafocus spoke to Dr John Fleming, Oncology Medical Head at GSK UK and Ireland, who said: “The COVID-19 pandemic had a huge impact on delivering clinical research in the UK. Initially, all site visits stopped and set-up of new studies and recruitment to ongoing studies was put on hold.
“This meant we had to find innovative ways of working to run and maintain oversight of our clinical trial portfolio.”
Bryan Deane, Director of New Medicines and Data Policy at the ABPI, explained the main challenges the R&D space had when COVID-19 first hit: “In clinical research [there were] two key challenges,” he said. “The need for social distancing and patients being reluctant to attend hospitals for anything including trial visits, and the redeployment of clinical research staff away from their normal work – to either support the NHS frontline, or work on research for COVID-19.
“Of course, we understand completely why those two things had to happen when the pandemic hit, but they had a fairly significant impact on clinical research and non-COVID research particularly; trials either had to pause or stop completely, and few new trials could be started.”
Speaking about preclinical research, Deane added: “Those areas have probably been affected in the lab as much as anybody else’s work has been. There have been some labs where people have carried on almost as normal but there’ve been a lot of places where you couldn’t have everybody going in. You can’t do the lab work from home but you can also not have everybody going into the labs as you used to. I think there’s been an undefined but clear delay on quite a lot of other preclinical research as well, but the clinical research impact is almost measurable actually.”
In fact, it is measurable. An article by Nature reported in its article ‘Clinical trial recovery from COVID-19 disruption’ that about 1,000 organisations had experienced trial disruption between January and September last year, with a decrease in new patients entering trials of around 80%. It also detailed that, of all active trials on ClinicalTrials.gov between March and May last year, 13% suffered from an increase in trial duration, compared with 9% the previous year.
Back on Track
After such an unprecedented health crisis and disruption, how does R&D get itself on course again? Clinical research prior to the pandemic involved a lot of patient visits to research sites – particularly in hospitals. The industry has had to adapt: remote monitoring of participants via Zoom, implementing digital consent forms, and allowing clinical trial medicines to be delivered to people’s homes. “But”, Deane said, “there is a limit to how much you can do online, particularly when monitoring people in clinical trials who are seriously ill.
“Clinical research in diseases other than COVID is still in the process of getting back on track. When you have an exhausted workforce that’s been dealing with a pandemic for months, it’s understandable that getting back on track takes time.”
GSK were able to work around the pandemic’s issues in a similar way, with Dr Fleming adding: “Direct-to-patient services were implemented, enabling subject visits to take place in the home where needed and direct-to-patient drug supply. We embraced the use of available digital technology to monitor the data we collect in our trials remotely.”
The company were also able to make use of the Urgent Public Health (UPH) scheme run by the National Institute for Health Research (NIHR) to help prioritise research that could help inform national policy and new treatments for COVID-19.
The programme has helped to coordinate and deliver trials, including funding support and the identification of sites to assist with recruitment.
Dr Fleming explained: “The biggest impact was the set-up of new studies, as NHS resources were diverted to run the COVID-19 research programme. These are now starting up again, which is great news for 2021.
“In addition, the UPH, which was instrumental in getting all the COVID-19 studies set up and recruiting in record time, is being piloted on non-COVID-19 studies. This has the potential to reduce set-up times going forward – a positive impact of the pandemic.”
The UPH isn’t the only positive development to emerge from the disruption to R&D. Pharmafocus spoke to Sheuli Porkess, Chair of the Policy and Communications Group at the Faculty of Pharmaceutical Medicine (FPM) in the UK, to discuss the faculty’s report into how the space can better plan for disruption to clinical trials in future.
As a result of the Clinical Trials Resilience Survey the FPM conducted in October and November last year,the faculty has identified four key themes to consider moving forward:
- The need for risk planning for pandemics to be reviewed and updated, in relation to all activities related to clinical trials and pharmaceutical medicine
- More of a focus of attention – and more funding – on infection
- Ensuring that small companies with innovative products and ideas are not overlooked, and instead are engaged and incentivised to participate in collaborations
- The need for more relevant pharmaceutical medicine and medicines development expertise in decision-making positions
Porkess explained: “We said [in September and October last year], we really need to see what has happened, what are the lessons we can learn, and what do we need to do differently for the future? There is not necessarily just going to be one wave [of COVID-19], we are thinking there will be further disruptions, and it might not be this pandemic – it could be different disruption. But we don’t want to be in a position in the future where we have such a level of disruption.”
Of course, these aims have been acted on over the course of the current pandemic, with Porkess especially keen to highlight the positive impact collaboration has had. “A lot of what’s come out [of COVID-19] will improve research and collaboration, because as anyone involved in clinical research [will say], we have had to have lots of discussion and thinking together – to decide how to trial for new vaccines for COVID, through to deciding what to do about trials for other diseases that got paused in the pandemic, and how we support patients back into research,” she said.
“We’ve had to have conversations and collaborations on a scale that hasn’t been done before and if we can keep that collaboration going that would be a really good thing. That’s certainly something the Faculty is really keen to do – say look, ‘We’ve got the expertise; how can we collaborate with the rest of the system, to really share that expertise and make sure that we can have the UK as a great place for clinical research, and also
Deane echoed these sentiments, adding: “An unprecedented scale of collaboration between pharmaceutical companies, academic researchers, health systems and healthcare professionals, governments and non-government organisations, such as the WHO, GAVI, and COVAX has helped accelerate research, and the development of vaccines in particular.”
These developments bode well for the future of R&D, while it also appears pharma companies are determined to make up for lost time by investing more in the space, as found by Binder Dijker Otte’s (BDO) 2021 Life Sciences CFO Outlook Survey.
The accountancy and business advisory firm quizzed numerous chief financial officers in the industry on their future plans for R&D, with 69% planning to increase their spending in the area this year.
This is despite R&D spending in the UK rising by 6.9% in 2019, according to data from the Office of National Statistics – an eight-year high.
Data are not yet available for last year, although Mark Tighe, Chief Executive of R&D tax relief specialists Catax told DDW Online in November: “It is a sector whose fate is intertwined with scientific endeavour and it would not be surprising at all to see its total R&D spending increase this year , although the industry will have to wait until next November to find out.”
If this proves to be the case then it will simply underline the amount of spending that has been apportioned to COVID-19 research, rather than standard R&D, which has fallen behind. BDO summarised their report by saying that they expected a “significant bounce back” of R&D investment outside of COVID-19 research this year.
So, how does R&D get fully back on track? Attracting patients through digital innovation, ironically brought about through necessity because of COVID-19, will help.
Porkess explained, “For research, we are considering how we can use technology to engage patients in research without them necessarily having to traipse into the hospital because they’re part of the clinical trial and we really have to think about how we make research happen in a way that can engage patients.”
Deane agreed, adding: “We’ve learnt a lot from the pandemic about just what can be done in a socially distanced way safely, and in ways that are more convenient to the patient.
“And we are learning more about COVID all the time, and discovering new vaccines and treatments, which are, in turn, helping to reduce the pressures that COVID causes in the NHS.”
The aim, ultimately, is that COVID-19 is managed as just one more disease in our midst. Until then, the new normal will continue, mitigating disruption and preparing the pharma industry for the future.