Perth based not-for-profit clinical trial facility, Linear, got early warning on the seriousness of COVID-19 thanks to a staff member who was visiting China and staying in the province next to Hubei. The trained nurse who is the Head of China Business Development for Linear, not only played a crucial role in alerting the organisation about the rapidly developing situation in Wuhan, but also managed to secure 400,000 N95 medical masks for her state of WA from China.
This is a neat illustration of what Linear’s CEO, Jayden Rogers, believes has put Linear in a good position to deal with the challenges presented by COVID-19. For him it’s all about the people and long term investment in innovation and culture.
“The true north for us, when COVID first hit, was always going to be to protect our volunteers and staff, that was going to be the key to all the decisions that our teams made,” he said. “I think the reason it has worked so well is because of our investment in our people. And that’s not something you can just turn on, we put a lot of effort into training and development and recently people have shown how agile, adaptable and flexible they can be when change is coming at a rate of knots.”
Putting volunteers and staff first meant reducing capacity on healthy volunteer trials. This resulted in less people undertaking trials so participant safety could be ensured. A number of healthy volunteer trials were slowed down or delayed. This had to be communicated to sponsors, but overwhelmingly they have been supportive of Linear’s approach. A strong focus was placed on those undertaking trials who were vulnerable.
“We have some very vulnerable patient groups in our clinic, we engaged very closely with specialists and the patients to understand the risks that COVID presented to them. In many cases these patients (for instance on oncology trials) are in such a challenging situation that the risk of not being able to access a trial is worse than the risk of COVID itself.”
With that in mind, Linear doubled down to protect vulnerable patients, by effectively locking down the clinic well before the practice became common, and before any domestic or international travel bans were put in place. A reduction in the overall capacity of the clinic was put in place as well as the creation of separate trial zones. Distancing between each clinical trial participant occurred by leaving an empty bed between each participant. Staff teams were divided up and worked separately to ensure participant safety.
“Thanks to our investment in technology we could move to remote monitoring, which means that only the people who must be in the clinic are there. We made the tough decision with our patients that family members couldn’t accompany them unless absolutely required. And we could get a majority of our staff working from home very rapidly.”
Another reason to continue trials for vulnerable patients was to help them stay out of hospital so that more beds are free for anyone who may get infected with the virus. For Linear it was vital to be well across the local situation in Western Australia. A local private company was engaged to undertake COVID-19 screening for Linear’s clinic, but only once it was established that this was not going to impact supply of COVID-19 tests for the state authorities.
“The testing has given us another tool in our arsenal of screening assessments to give us a higher level of comfort that we are unlikely to have anyone in the clinic who is positive to COVID-19,” said Jayden. “We also engaged very early with the Sir Charles Gairdner Hospital and the wider medical community in terms of what we could do around the broader response to COVID-19. We brought in experts such as infectious disease and emergency medicine specialists to evaluate what we were doing. That was really helpful and gave us a lot of comfort on the processes that we were putting in place.”
But Jayden is keen to point out that it’s not just Linear that is going above and beyond when it comes to responding to COVID-19. He believes that the whole sector across Australia is doing good work as well as the authorities. However, we are at the beginning of a long battle. Linear has a planning ahead team for COVID-19 as well as a COVID-19 team that meets daily.
“It’s about continuing to innovate and find ways not to just cope with it, but to fight it. That’s been part of our mantra. It’s a psychological battle as much as it is an infectious disease. So it’s important to fight it in as many ways as possible. I think we are privileged in some ways to work as an industry that is at the heart of that fight.”
While acknowledging that the sector as a whole is doing great work in dealing with the challenges of the pandemic Jayden has three tips that have helped steer Linear’s course ahead of the curve.
- Ongoing investment in people, culture and technology is crucial
- Listen to what the data is saying and move quickly
- Communication is key with all stakeholders including trial participants, staff, investigators, sponsors, institutions, suppliers and authorities
Linear has recently announced it will be an Australian testing site for a COVID-19 vaccine and has put a call out for healthy volunteers.
(Interview and article on behalf of Bellberry by Alison Rogers, Living Stories)
For more information about practical adjustments to modify Clinical Trials for the COVID-19 period please refer to:
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