2020 in review: COVID-19 and patient centric clinical trials

Views & Analysis
2020 in review: COVID-19 and patient centric clinical trials

The trials and tribulations of 2020 have brought the vital role of research, pharma, and biotech into sharp focus. But how has the push to develop treatments and vaccines for SARS-CoV-2 affected the industry’s commitment to patient centricity?

This time last year, researchers and industry players were working hard to embed patient centricity and engagement into their everyday work.

Then COVID-19 hit, and organisations big and small were forced to pivot operations to tackle the real and present danger of the pandemic. Since then, we have seen some mind-boggling scientific achievements, with innovations in vaccine development being just such one example.

But how has this global push for SARS-CoV-2 vaccines and treatments affected the research community’s commitment to patient centricity? We take a look back over the last 12 months to find out.

Green shoots of engagement

At the start of the year, the industry was busy incorporating the patient voice into trials in a bid to overcome the recruitment and retention problem – the figures showed that fewer than 5% of all those eligible to take part in research signed up, and the global average dropout rate was around 30%.

“The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight.”

While the research community was aware of the benefits of patient centric trials, however, they were still unclear on how to put that into practice, said patient engagement agency, Couch, back in February.

Said the team: “In the Annual Patient Centricity Benchmark Survey, when asked about training or preparing people to behave in patient-focused ways, over half of employees from biopharmaceutical and medical device companies said: ‘We are actively looking at how to teach this to our people’.

“Only 22% selected: ‘We know exactly what and how to teach this to our people’.”

That said, the community was going in the right direction. In March, we reported on how researchers were increasingly using methods such as patient-reported outcomes, remote reporting, and lay summaries to boost engagement.

Widespread interest

But then the pandemic piqued people’s interest in medical research at previously unimaginable scale.

The RECOVERY Trial, a multi-arm RCT studying the efficacy of several repurposed treatments in COVID-19, recruited a staggering 2,000-plus people across 16 NHS sites in little more than three weeks. At the same time, thousands more signed up to report their health status to the King’s College London COVID Symptom tracker app every day.

Speaking to pharmaphorum in May, Dr Sheuli Porkess, Executive Director of Research, Medical and Innovation at the Association of the British Pharmaceutical Industry (ABPI) said, if harnessed correctly, such changes could benefit research efforts for years to come.

“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’.  I think we really need to look into what it was that enabled people to sign up so quickly.”

The pandemic also accelerated the adoption of many patient centric study practices. Remote monitoring, for example, went from a nice to have to a necessity overnight. In doing so, it proved it could provide robust data at the same time as reducing participant burden.

Casualty of speed?

But while the pandemic certainly created a collaborative discovery atmosphere, it also introduced an element of intense urgency – and this has, arguably, had a detrimental effect on engagement in research.

In November, pharmaphorum reported from the Pioneering Partnerships conference, organised by the ABPI, the National Institute for Health Research (NIHR), and the Association of Medical Research Charities (AMRC). We asked if rapid progress and patient engagement were mutually exclusive.

NIHR director, Jeremy Taylor, said: “One of the consequences of the system commissioning lots of urgent COVID-19 research was that, to a certain extent, patient and public involvement got bypassed. For various reasons it was too difficult or too time consuming to do when everybody was in a frightful rush.

“Patient and public involvement turned out to be less embedded than we thought, so I think COVID has been a bit of a shock to the system. It’s made us think that maybe we have been a little too complacent.”

Lessons to learn

The last 12 months have been something of a whirlwind for everyone, but the healthcare and research community have been in the eye of the storm.

In 2021, the research community can build on the widescale adoption of remote monitoring and huge increases in study recruitment rates, but it must also put what it has learned about “doing” engagement at speed and at scale into practice.

  • Want to read more about how COVID-19 has impacted in patient centricity? Check out the latest edition of pharmaphorum’s Deep Dive magazine, which is dedicated to the topic.