‘No going back’ for clinical trials

‘No going back’ for clinical trials after COVID

Trial sites have adapted swiftly to the restrictions of COVID-19, and patients have seen many knock-on benefits as a result. The next step is ensuring the industry does not regress to old ways of working once the pandemic is over, say Karen McIntyre and Allyson Small.

COVID-19 has changed everything for clinical trials – but in most cases these are changes that were well overdue.

“For years and years, the industry has debated the practicalities and safety of decentralising clinical trials, using telemedicine, and where study activities should take place,” says Karen McIntyre, executive director, global lead Catalyst Program & site relationships at Syneos Health. “We were always having these discussions, but nothing moved forward.”

When the pandemic hit, regulators around the world rapidly updated their guidelines to reflect the realities of conducting trials amidst lockdowns and social distancing mandates.

“For example, drugs are now able to be delivered directly to patients to allow for a clinical trial visit to take place remotely,” says McIntyre.

“These changes didn’t necessarily need to involve advanced technology – we just had to adapt the way we worked.”

She says that sites quickly rose to the occasion.

“We really saw sites’ commitment and dedication come to the fore. They adapted quickly and were incredibly flexible, and rapidly became confident that, yes, they can continue to work effectively and safely with patients in the new normal.”

McIntyre had first-hand experience with just how effective alternate ways of interacting with patients can be when her husband presented with shingles just days after lockdown began

“Normally, we would phone our GP surgery in the morning to try and get an appointment. In the likely event that we couldn’t get an appointment that day, we’d have to phone again the next day, and the next, until we’re finally able to see a doctor.

“This time, though, I just took a photograph of my husband, emailed it to the doctor and got a phone call 11 minutes later to say that there was a prescription at the chemist.”

Now, she says, the industry is wondering why it was ever afraid of change.

“These approaches have all worked, and they’ve made clinical trials much more inclusive. Everything has changed, and I think that there’s no going back.”

Diversity and access

One change McIntyre has seen is that the industry has stopped focusing on the challenges of implementing new clinical trial technologies and is now looking at what sites already have and what they need going forward.

She adds, though, that the industry has to be wary of imposing technology on sites.

“One size won’t fit all. Technology that works for a large academic hospital won’t necessarily be optimal for a dedicated research site. The industry also needs to think long-term – don’t make technology for one specific study, but technology that can be reused for multiple trials.”

A huge boon of adaptations like remote monitoring is they make patient access to trials wider than ever before.

“Most people live hours away from their nearest clinical research centre – and for people with rare diseases it might even be in another country,” says Allyson Small, COO at the Society for Clinical Research Sites. “If you are working full time, or have a family to look after, that means you’re prohibited from being included in many studies.

“Having flexibility therefore means that clinical studies can be much more diverse, allowing researchers to bring in patients from all over the country or even the world.”

She notes, though, that it will be important to ensure patients have as many options as possible for how they participate in trials – for example, many patients still value human interaction above anything else and are keen to get back to their trial sites. For this reason, Small and McIntyre say hybrid trials are likely to be the dominant format in the future.

Similarly, many patients also have safety concerns with remote trials, and making sure that all patients feel safe outside of a typical trial setting has been a key task for sites.

“Before COVID-19, a term that was being bandied about a lot was ‘siteless trials’ – but really you can never have a siteless trial, because you will always need clinical oversight,” says McIntyre. “It’s not just about bricks and mortar, it’s about being able to conduct these procedures safely, and sites are just as important for remote and decentralised trials as for traditional trials. I think people realise that now – I haven’t heard anyone use that terminology in months now.”

A pledge for progress

It’s too early to say whether regulators will want to keep more flexible rules in place once the risk of the pandemic is gone – especially when each regulator is different, and this has been a worldwide phenomenon. But McIntyre says the industry’s opinion on the matter couldn’t be clearer.

“Everybody you talk to will have different opinions, but overwhelmingly, the industry response has been that there is no going back.

“We have learned that we can reduce the timelines of study start-up and increase diversity of participants, and that there are multiple ways we can collect safety data and get investigation products to patients. It’s been amazing to see the collaborations that have driven that.

“We need to keep progressing and not regress back to endless discussions and debates. We’ve learned that it can work, that we can stop thinking that a clinical trial site is a place – rather, a clinical trial site is an activity.”

To this end several companies have come together to support the #NoGoingBack movement launched by Signant Health – which is asking people from the industry to pledge to keep clinical trials moving forward into this bold, patient-centric future and not let progress slip away.

The movement’s charter asks signatories to honour the lessons the industry has learned – namely that patients deserve and want flexible options for trial participation, that the industry can adapt faster than it thought it could, that collaboration between competitors is needed for acceleration, and that pharma has an “unparalleled opportunity” to make huge improvements in drug development.

“We need to keep this acceleration in technology adoption and new ways of working moving forward,” says Small, who is one of the campaign’s chairpeople. “It was amazing to see everyone, from sponsors to CROs and sites, rallying together at the beginning of the pandemic to share experience and ensure clinical trials could continue to serve patients, and we want to make sure that effort wasn’t in vain.

“If we do that, we can move away from a ‘one size fits all’ approach to trials. Every patient is different, and to have one protocol with no flexibility adds unnecessary challenges to sites.”

McIntyre adds: “So far everything we’ve done has been through protocol deviations, and now we’re asking for regulators to work with the industry to create protocols that will allow for those flexibilities and are inbuilt into the clinical trial process.”

She believes this goal is eminently possible.

“I think regulators are seeing the benefits. We’ve proven that we can do this. Never before in my career have so many people from all levels come to ask me what’s happening with the sites. That shows there’s a real drive here, and now we just need to make sure that sticks.”

Karen McIntyre is executive director, global lead Catalyst Program & site relationships at Syneos Health. Karen brings almost three decades of industry experience in a variety of therapeutic areas including cardiovascular and metabolic disorder, women’s health, neuroscience and infectious diseases in phase II through phase IV clinical trials. With a special interest in site support Karen has been involved in the development of Site Support Management tools with the goal to improve quality, transparency and compliance across investigative sites since 2005. Karen is also an active member of National Research Ethics Committee, Scotland.

Allyson

Allyson Small is chief operating officer of the Society for Clinical Research Sites (SCRS). With nearly 20 years of experience working in the healthcare industry, Small joined the SCRS team in 2013. She plays an integral role in strategic growth, developing key partnerships, and increasing global membership by 80%. Small also oversees all development and production of four International Summits. Small is a champion for creating a voice for clinical research sites across the globe and assuring site sustainability.

Syneos Health is the only fully integrated biopharmaceutical solutions organisation. The company, including a contract research organisation (CRO) and contract commercial organisation (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry-leading companies – INC Research and inVentiv Health – it brings together approximately 24,000 clinical and commercial minds to help its biopharmaceutical customers shorten the distance from lab to life.

George

George Underwood is a senior member of the pharmaphorum editorial team, having previously worked at PharmaTimes and prior to this at Pharmafocus. He is a trained journalist, with a degree from Bournemouth University and current specialisms that include R&D, digital and M&A.

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