ABPI’s Sheuli Porkess on how COVID-19 could improve clinical trial conduct
COVID-19 has shifted the global gaze onto the topic of medical research – and is starting to transform the way we see and do clinical trials. We speak to the Association of the British Pharmaceutical Industry’s (ABPI) Sheuli Porkess about seizing the opportunities of the pandemic crisis.
Improving recruitment, expanding inclusion, and deepening public involvement are three elements of clinical trial conduct that the industry has been working to improve for some time.
And with the advent of the COVID-19 crisis, progress on all three has accelerated significantly. It’s the perfect opportunity to learn lessons and apply them across therapy areas, says Dr Porkess, Executive Director, Research, Medical and Innovation at the association.
“Now, more than ever before, people are looking to research for answers, and I am very conscious that, in order to provide those answers, the research we are doing needs to be robust and reliable,” she says.
“The current laser focus on COVID-19 research is absolutely the right thing to do to make sure we get the vaccines and treatments as soon as we can, but we need to make sure we do that in the right way so that those products are safe and effective.”
Studies are being improved “at incredible speed” and different ways of conducting trials – methods that have been discussed for years – are now springing up almost overnight.
“We need to learn from what is going on right now so that, at some point in the future, we can apply these learnings to all trials,” says Dr Porkess.
Accelerating recruitment
The issue of poor trial recruitment and retention is a well-known stumbling block in the industry. Fewer than 5% of all those eligible to take part in studies sign up, and the global average dropout rate is around 30%.
But recent developments have yielded unheard of results. The RECOVERY Trial, a multi-arm RCT studying the efficacy of a number of repurposed treatments in COVID-19, recruited a staggering 2,000-plus people across 16 NHS sites in little more than three weeks.
Thousands more people are currently reporting their health status to the King's College London COVID Symptom tracker app every day.
“The studies are being covered on the news and that’s great for letting people know how they can get involved in research right now.
“What’s more, that ongoing exposure to discussions around trials and what people do when they are in a trial will, in the future, help people to say ‘yes, I want to be involved’. That’s not necessarily all about COVID, but it might be in disease areas that are more relevant to them.
“I think we really need to look into what it was that enabled people to sign up so quickly. These are things we are keen to explore at the ABPI.”
Accelerating digitalisation
The digitalisation of clinical trials is not new, but approaches such as remote monitoring and patient-reported outcomes have struggled to make it to primetime. Now, that too is changing.
In April, the National Institute of Health Research (NIHR) published its “commitments to public involvement, participation and engagement during COVID-19”.
The document, which is aligned to the UK Standards for Public Involvement, sets out how the body’s Public Involvement Senior Leadership Team aims to ensure patients, carers and the public have a say in shaping health and care research during the pandemic.
Jeremy Taylor, NIHR Director for Public Voice and Director of NIHR Centre for Engagement and Dissemination, said: “Health research should be a shared enterprise with patients, carers and communities.
“COVID-19 has not changed that. Indeed, the public contribution to research on the pandemic is vital.”
Dr Porkess welcomes the news, saying such initiatives would make patient involvement easier and help build the knowledge base for future trials.
“The NIHR has said we still need patient and public involvement, even though people can’t get out, so it should be done remotely. That way of thinking has opportunities going forward, because if we start realising that we don’t necessarily need patients to come into the hospital or the consultation room, we can be more inclusive,” she says.
Such methods are now a necessity and researchers have no choice but to make them work.
“Everyone has sat in a meeting over the last couple of months where the video has frozen or the sound has dropped out. But with each case study, we are building best practice within the patient engagement community.
“I think we will get through those issues and it will become normal,” says Dr Porkess.
Accelerating involvement
COVID-19 is without doubt the biggest challenge the healthcare sector has faced in years. But that doesn’t mean it is without opportunity.
“Different parts of the ecosystem, whether that’s industry, the NIHR, or the research and patient communities, all understand that if we want to have good medicines and a good health system, we need to involve patients. Right now, it does feel like it’s all coming together.
“I think COVID gives us a huge impetus to make sure we get things right, learn from them, and take the changes with us into the future,” concludes Dr Porkess.
