Associate feature: Adapting to the new medical research world

Scotland has always played a significant role in medical research, but since the spread of coronavirus this has become more important than ever.

Bolstered by a world-class research infrastructure, leading expertise and the willingness of patients and the public, the NHS has adapted to a new research environment and made a significant contribution to global efforts to tackle and mitigate the impact of COVID-19.

Of the many coronavirus-related research projects that Scottish researchers are involved in, three in particular stand out: GenOMICC, RECOVERY and the Oxford vaccine trial.

GenOMICC is an “enormous study of huge importance” and already “hugely successful”, according to Scotland’s chief scientist, Professor David Crossman.

The project is studying the human genome to try to find out why some people are severely affected by coronavirus while others only get a mild illness.

Led by Dr Kenneth Baillie at the University of Edinburgh, it has already worked with 3,000 COVID patients.

GenOMICC has also been expanded to look the genetics of the SARS-CoV2 virus itself, which has changed since it was first detected in China in December.

The universities of Edinburgh and Glasgow are both involved in the COG-UK (COVID-19 Genomics UK) consortium, which is working on the RNA sequencing to understand the transmission and evolution of the virus – an area in which the UK is leading the world – and Scotland has been a major contributor to that programme.

The RECOVERY trial, run from Oxford and involving every health board across Scotland, has become the world platform for phase two and phase three drug research in COVID-19.

RECOVERY tests whether existing drugs used for other illnesses can help to treat coronavirus. Crossman says that like GenOMICC it has been a “huge success” and is “world leading”.

No other country has put together such a consortium approach and it has been reported as the fastest growing clinical trial in medical history. 

So far RECOVERY has had two significant results.

One is that dexamethasone, which is a routine and cheap steroid, improves survival in people with severe respiratory problems caused by COVID-19.

The other is that hydroxychloroquine has not been found to help treat coronavirus.

The third and perhaps most high-profile research project is the Oxford vaccine trial, which is at the forefront of trying to find an effective vaccine to protect against COVID-19.

Researchers in Scotland have been involved in this project, which is now at the testing stage, and Scotland has joined with the other nations in the UK in encouraging the public to get involved in the large-scale trials that are needed to develop a vaccine.

A central database, the NHS COVID-19 vaccine research registry, has been created by the National Institute for Health Research and NHS Digital on behalf of the four UK nations.

This allows those interested in volunteering for COVID-19 vaccine trials to register online and give permission to be contacted by research teams, helping these trials to proceed more quickly.

You can register to take part in the trials at www.nhs.uk/researchcontact.

Research has been a rapidly moving area: over 60 COVID-19 studies are running in Scotland and in April the Chief Scientist Office awarded nearly £5m of funding to 55 rapid research studies across 15 Scottish universities and other institutions for coronavirus-related research that can be completed within six months. Key to all this is the research environment in Scotland.

Crossman explains: “We have a proud history of medical research in Scotland, but COVID-19 has really shone a light on its importance, and this gives clear sight of three really important and powerful things about Scotland.

“One is the infrastructure that is in place for doing research. You can’t just say, ‘I’m going to do some research,’ you need to have all supporting infrastructure to maintain the quality and integrity.

“Scotland is quite unique in this respect and our research infrastructure is very well coordinated – all our health boards are research active, the partnerships across NHS and academia are solid and our country-wide collaborative approach allows us to work at scale, reduce duplication and accelerate the pace of research.

“The second is expertise. Scotland is home to some of the most respected researchers and scientists in the world. It is an impressive group across NHS and academia.

“And the third is, of course, the patients, who seem to have significant alacrity for participating in research.

“And I think that not only are they to be thanked, those that have taken part, but they are to be acknowledged for their support of research and seeing the importance of it.”

All this new research has been turned around with great speed, considering the first case of coronavirus in Scotland was only at the beginning of March.

“We’ve turned the service of research in the NHS around to COVID-19 research extraordinarily quickly. That’s a major achievement. It really is,” says Crossman.

“Every part of the research process has been expedited, from approvals to ethical evaluations, prioritisation of studies, set-up and recruitment of patients.

“People have gone the extra mile to make sure that things have got done at the speed they need to. And I think it’s a very impressive effort and provides important lessons for the future of research in Scotland.”

While COVID-19 research has been the focus for the past few months, non-COVID-related medical research that had been put on hold during the peak of the crisis is now restarting, but that is not necessarily easy in the new environment.

“Before the pandemic, Scotland had a really strong and diverse portfolio of health and social care research. Restarting this research is a big undertaking for a number of reasons,” says Crossman.

“The first is, COVID-19 research is still ongoing, and so we’re restarting research in other therapy areas alongside that.

“There will probably be more vaccine trials and there may be more clinical research trials in COVID-19, so it is a complex environment.”

There are other practical challenges, too.

“The most obvious thing to say is, we can really only restart clinical research as the clinical services restart,” Crossman explains.

“So, 45 per cent of our non-COVID studies are embedded in clinical service, of which the vast majority are cancer studies.

“Diseases don’t stop because of the pandemic, and so getting research restarted is critical – it offers future treatment options and is vitally important for so many patients – but this has to be done safely.

“Patient and staff safety is priority. Site readiness and viability of studies are also part of the assessment on restarting research.

“We also need to be mindful that things won’t be at the same pace as before because obviously distancing measures, additional cleaning of machinery, access to some of the required additional scans and such like have all changed. The way the NHS operates is different and this all factors into when it is safe to restart.”

NHS Research Scotland has a restart advisory group that meets every month, supported by a restart operations group, and their metrics suggest both commercial and non-commercial studies are restarting.

Crossman again praises the “alacrity” of the Scottish people, and their willingness to get involved in research.

A recent survey of patients found that only 15 per cent of them said they would not go to hospital to take part in a research study because of coronavirus fears.

But some of the other changes may be more permanent and, like many other aspects of life, researchers have to take account of the new normal.

Crossman says: “In terms of restarting, we are having to adapt to the change in the way that clinical services are delivered.

“The remote consultation and Near Me processes, for example, are quite significant and will impact on primary care and outpatient visits, so we will have to adapt to that in research terms.

“The research methodology needs adapted to support electronic consent, remote access to patients and the ongoing interaction.

“Like all areas of NHS, we are having to adapt and think about how we deliver important research. It is a different world, there is no doubt about it, but one constant is that research is a vital and integral part of our NHS.”

This piece was sponsored by NHS Research Scotland