In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date. Read Part 1 of the conversation. In Part 2, we look at patient engagement and the conduct of clinical research, shifting the conduct of clinical trials for patients and the industry, working with regulators and the future of industry collaboration. This conversation has been edited lightly for clarity.
Trial Conduct: Adaptation at A Global Scale
Is there anything that has surprised you about the conduct of clinical research in the COVID era?
COVID has brought an expansion of things that we’ve already done. Working with sites to get direct access to their electronic health records was a lot of work. We already have that in many places but that remote access to enable remote monitoring was not that widespread.
The amount of work needed to get it done in each case, adding it all up site by site, trial by trial, working at this scale was a lot of effort and we were surprised a bit by how much effort that was to do it all as quickly as we did.
How has COVID impacted enrollment and patient engagement?
Some of the trials that you’d naturally assume would grind to a halt, didn’t stop, and some that you thought would be fine, ground to a halt. You really get to see the different mindsets of the different patients being challenged by different indications and diseases.
In the early days of COVID, we saw a lot of patients enrolling into new asthma trials or new respiratory disease trials because early on, COVID was considered very dangerous to people with asthma or respiratory illnesses. We saw a lot of people without medical coverage try and get on a medicine for a respiratory disease before COVID really arrived. We saw the same for cardiovascular and pulmonary indications, but not as marked.
Engagement with oncology patients probably went up quite extensively, because those people are very conscious of when their next infusion is, when their next treatment is, and they put a lot of forethought into getting those treatments safely. A lot of oncology treatments are immunosuppressive, so these are people with compromised immune system in an environment where a compromised immune system isn’t a great thing. A lot of thought went into engaging those people in those indications. Some of the longer-term chronic indications like diabetes have been harder to keep people engaged.
For people with real life-challenging illnesses, COVID represented a very, very big inconvenience of staying engaged in a trial. We worked to make it easier for them and they worked to be as compliant as they possibly could be.
One of the things we’ve been watching very closely is the patients that you lose during a trial. To prevent trials from running long, you’re watching very closely to making sure you’re not going to lose a bunch of patients, so you put a lot of effort around that. But the loss of patients has not been an issue, because of the work we’ve put in to engage those patients throughout the COVID period. One of our lessons is that this engagement is something that we should do on a daily basis.
How does the clinical research and technology industry evolve and stay agile for the next pandemic, but also for the next status quo?
The CRO industry in general has shown an incredible amount of agility and resilience. And doing the right thing. It’s great to see all the CROs continue to make sure that trials are ongoing, most of the time without contractual coverage from customers. COVID hit and we couldn’t sit there and say, “For us to do all these extra bits and pieces, we’re going to need a change order.” The CROs just got on with it and it done. And our customers have been great, saying we did the right thing, and we’re working it out, financially.
We’ve all been able to shift to remote work. We kept all our people safe. We kept the patients safe. That ability, that instinct to do the right thing – people should be very happy that the CROs all think that way.
What is the industry learning from the handling of the challenge of COVID?
Syneos Health has 39 COVID-specific projects. We’re engaged as the delivery horsepower for the trials to get them done. When you think about the possibility of having a vaccine by the end of the year, it’s amazing that it can be operationalized that quickly. The time it will have taken us to design, approve, execute and put a drug on the market, will probably be a 12-month period. Normally, it takes our regulators 6 months just to approve a trial to start. We’ve got to look at that.
This a common theme: our connectivity to the regulators, our ability to work together as regulator-pharma-CRO-sites-patients – it needs to be pulled together, rather than this very difficult, complex process that we’ve created over several decades to get an experimental drug into a clinical trial.
Yes, the rigor and the discipline around regulatory review needs to be there. But paperwork doesn’t need to sit on the regulator’s desk for six months while they decide that we should get around to talking about this and get it approved. There’s got to be innovation around the approvals process that can come from the digital side that can help us move quicker and help get trials up and running faster.
If we’re going to see something stick, it should be that approval speed. Further, an increased pace obviously saves money. We hear from governments that trials are so expensive, and yes, they are when we sit around on our hands, waiting. The fact that COVID has been a truly global challenge has enabled global solutions between regulators, proving that they can work together.
How is the industry working together and contributing to solving these global challenges?
I’ll take Syneos Health as a microcosm of the industry. We’ve published training materials and advisories on using CPAP and BiPAP machines as a treatment for COVID, as soon as it started. I know that IQVIA has done public service, I know that ICON has, that PRA has, and I know that we have. ACRO got volunteers together in the UK to staff testing centers. Those kinds of things have happened all over the world from our industry.
As the Chair of the industry body this year, I’m super proud to lead an organization and an industry organization where it’s a bunch of really good people who compete like crazy every day with each other to build innovative solutions that are right for our customers and the patients. But when all this happened, all the gloves came off. The industry came together.
We’ve worked together to put volunteers out there, to put doctors back on the front lines instead of working for us practicing medicine. CROs are working with governments on vaccine challenge trials, on public health matters, teams of volunteers and more. It’s the kind of thing that makes the hair on the back of your neck stand up, that you’re involved with people of such high caliber. We should be very grateful to work in an industry where there’s a lot of good people who do good things – the right kind of things.
We’re driven constantly to grow and think about financials, but at the end of the day, when people need help, it’s nice to know that we work in an industry where we will step up to the plate and help the population in general.
Alistair Macdonald is CEO of Syneos Health, and Chair of ACRO’s Board of Directors.