COVID, the role of digital, and the future of clinical research: A conversation with Alistair Macdonald – Part 1
In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date and what lessons can be learned. From public perceptions of clinical research to the rise of digital platforms to the impacts on patients and trial sites, in Part 1 of this conversation, we look at what this year has meant for Syneos Health’s work and the broader industry. This conversation has been edited lightly for clarity.
Participation is at the core of clinical research. How has COVID impacted how you think about participation in clinical trials?
From a different angle, COVID created a massive amount of inconvenience to people. We couldn’t engage in public life. But some of the restrictions on people during COVID are restrictions that many people in clinical trials are already dealing with. People with immune deficiencies, cancer, acute CNS disorders and schizophrenia have issues getting to a doctor or to a hospital. There is something that stops people from feeling like they can go out. Seeing clinical trials through the lens of COVID accentuates the problems that people have with participating in clinical trials – it’s inconvenient.
COVID has been a kind of pressure test in terms of where the industry was already moving. What we’ve been doing as an industry is trying to work out how we get more people interested and engaged in clinical trials and how we drop the inconvenience. How we make it easier. How we make clinical trials easier to do business with.
Has public perception of clinical trials changed in the COVID era?
This is the first time that a lot of people have recognized that clinical trials are important. The COVID experience for patients and the general population has shown them why clinical trials are important. And it will create a tailwind for people thinking of trials, and not just remembering a trial where there have been problems that made headlines. This is the first time globally that clinical trials have been seen in the right light – the way we see clinical trials on a daily basis.
So much of our lives have moved to digital platforms. We’re on webcams for work and children are attending school virtually. Is digital the answer to reducing inconvenience?
The answer is not always digital. If I’m a cancer patient, I don’t want a digital appointment, I want to go see an oncologist. Now, there is a place for it and there are elements of it that you can bring into trials to make participation easier from a patient perspective, absolutely. And I think a lot of those things have come to the fore during COVID because we’ve had to work out how to keep patients in a trial, how to make it more convenient for them so that we’re not losing patients from trials. It’s been an accelerator in the way people think about the convenience of clinical trials and how we can engage patients more readily.
Because we’ve had to do it from the middle of March onwards. We’ve had to have mechanisms where we can talk to sites, look at the data, get engaged with patients from an enrollment perspective, all from a purely virtual stance. Most of that virtual connectivity has been between CROs and the sites, because there’s very little direct-to-patient engagement for the CRO, but certainly engaging patients through their data, or engaging their care providers through data and digital, is something that everybody is doing but that we will do more of post-COVID.
At Syneos Health, we’ve invested in digital technologies where we could shift to remote monitoring, and on the commercial side, the remote detailing of doctors, making sure that their orders got fulfilled and patients got reimbursed. That all proved to be very robust. And we have a platform where we can engage doctors face-to-face where they want education, or offer the support they need around a specific product. Rather than taking samples into a doctor’s office, we’re able to do that digitally. I think there’s been a lot of pressure on the smaller CROs who don’t have the ability leverage the systems they have and move as quickly as the big ones.
Were sites and patients ready for this sudden emphasis on digital?
Right across the business, I think customers who are used to engagement in a traditional fashion, who are expecting to see a monitor or a nurse educator face to face, they were forced to accept digital engagement. But it’s personal engagement over a digital medium, so it’s more telemedicine or a telepresence rather than a true shift to some whiz-bang “platform.” If you read the news around this industry, you’d think that we did nothing but decentralized trials, but we’re a long, long way from that. That’s a part of our future but it’s more the digital engagement of end users that has been the big change rather than a shift to a completely digital trial format.
Were you worried about any of those shifts to digital?
Not really. We’ve been investing in these channels for a while. We see a lot of this digital engagement as just a tool for people – a way to cut down travel and give people a better work-life balance. We do recognize the ongoing progress in making visits virtual or making trials decentralized and we do that already, so we’ve been seeing that transition coming. The big shifts for us during COVID were transitioning the whole workforce to work from a remote location, establishing how the sites can engage with that configuration, and how the patients are going to stay on treatment if sites have completely closed. Patient-based business got down to maybe 20% during April and it’s now back up to maybe 60-70% so it’s coming back.
But you’ve got to think about the providers. We’re the coordinators – the general managers of the trial. You’ve got the treatment end, which is the sites and the physicians. And then you’ve got the patients who are the customers. And you’ve got to think about those three constituencies – how each one operates. We were confident in our piece of the operation and how we plug into the sites, but then you worry about that last connection – the site to the patient. You’ve got to think about how we can help them make sure these three constituencies come together consistently. We’ve done a lot of work around that, making sure medication got delivered safely and compliantly to patients at the right time for them to take.
How are digital tools helping you engage patients with sites being closed?
If patients couldn’t get into a site, we used AiCure. It’s an app that watches the patient take their medicine, and it can tell if someone hides the medication in their mouth without taking it. It’s all about facial expression. We have mechanisms that we can use on trials of a specific type to make sure that we could see compliance to medication.
Syneos Health has over 24,000 people around the world. What kind of changes has the digital shift brought to your workforce?
There has been a lot of use of digital tools. The flexibility of the team has been fantastic. The resilience of the team has been something that I’ve been very pleased with. Culturally, they’re stronger now than when they went into COVID because they’ve had to work through things together and challenge themselves, all while doing it from individual locations in their own homes. That was probably the hardest part – making the call on going to a fully remote stance, globally.
We pulled Asia out of the field and then we pulled Europe and America out of the field about a week or 10 days before government lockdowns went in place, because it was inevitable. And it gave us an extra week or so shift everything remote, to make sure the systems were able to scale to the levels we were expecting them to. That was probably the hardest transition – making sure people had everything they needed and that they were able to work from a location that they were going to make it through while taking care of their mental health and wellbeing.
I’m an advocate for mental health. Making sure that people were physically safe was our number one priority. And secondarily, with people out of the field, ensuring that we keep this community together, keep people engaged and stimulate their mental health. And I think that we’ve done a relatively successful job at that. From the earnings calls across the industry, which is our window into what everybody else is doing, it’s a pretty common story.
We’re lucky to be in a sector that can’t shut down. A cancer patient doesn’t have the option to say, “I’ll stop taking this medicine for six months.” COVID is a secondary issue for that patient. We’ve got to be able to continue as an industry. Our two priorities became, one, keep everybody safe, and two, make sure we keep patients current and compliant with their medicines. Because they need us to. These are experimental medicines so the doctor can’t just call the pharmacy and order a new one. It doesn’t work like that. Making sure those supply chains were intact, making sure we could serve our customers – the patients and sites – became the two overriding principals in how we handled COVID.
Alistair Macdonald is CEO of Syneos Health, and Chair of ACRO’s Board of Directors.
Stay tuned for Part 2 of this conversation.