“Normally it would take five to six months, minimum,” says Lona McDonald, Operations Programme Leader, Clinical Operations, at Roche. “Depending on how many countries and sites you're in, it could take up to a year or more. It depends on studies, indications, the size of the study. But the first study we set up during the pandemic took just over two weeks. To be honest, even after having lived it, it doesn't seem real saying it.”
How did they do it? “The short answer is ‘pandemic,’” Lona says.
But behind-the-scenes details tell the full story. Focus, teamwork, simply a lot of work compressed into a tight timeline – while working remotely under lockdown conditions, no less – got the trial from zero to the first active study site within a mere 15 days.
“First, it was absolute prioritisation,” Lona says. “This study was incredibly important in terms of global efforts to address the pandemic. We were given an email that basically said, if you need resources or someone to do something, take this to the highest level in any department, and they will give you what you need. I didn't quite believe it, but I used the email and it happened.”
Lona was working on two other projects when the call came to assemble and lead a launch team. Immediately.
“I literally walked away from those projects overnight,” she says. And everyone who came into the urgently formed team had that same spirit. That's true prioritisation. We generally don't do that very well. But if you take this approach, it needs to be for something really important. A lot of teams were disrupted for us to be able to do this. So there has to be a level of acceptance within the broader organisation that to support a priority programme, there will be disruption elsewhere.”
Another integral piece of the puzzle is the co-creation with vendors, colleagues and affiliates across many countries. More than 300 people were involved in this programme, with some 40 to 50 on the core team.
“It was very collaborative,” Lona says. “We worked as one team, and everyone just did what needed to be done. Nobody said ‘we don’t have time’ or that's not my role.’ This time it was a case of ‘it needs to be done, we'll just get on with it and do it.’”
The heightened sense of urgency and cooperation wasn’t just at Roche. It extended to government health authorities, ethics committees, study sites – everyone was prepared to do what it took.
“We had health authorities agreeing to meet at all hours,“ Lona says. “The FDA reviewed our protocol in 48 hours. That’s not normal. That was a pandemic situation. Normally this would take 30 days.”
Subsequent Roche trials, also launched during the pandemic, were fast, but not as fast as the first.
“Health authorities and ethics committees are now settling into a new normal,” Lona says. They still review things quicker, but not as quickly as say, meeting at 10 o'clock at night to review the protocol.”
Another aspect that helped the team succeed was a high level of trust. The core team knew one another and many had worked together for more than 10 years. “Without that, I think it would have been more difficult,” Lona says.
In the first hours and days as the team assembled in early March, they perhaps didn’t realise the magnitude of what was happening, Lona says.
“We were still coming into the pandemic,” she says. “Everyone was in a bit of a ‘we'll be OK, it'll be fine’ mindset. Within days, even hours, we realised this was something much bigger. We knew we had to rely on each other; no room for doubt. In my 23 years at Roche, the entire time in clinical development, I’ve never seen anything like this. The internal pressure was unprecedented.”
The core team worked 16-hour days, 7 days a week, for 10 weeks. Lona says that tenacity is a testament to the caliber of people throughout Roche, and their commitment to serving patients. “There wasn't a single person I came across who complained – and I spoke to many people in my direct team and in all functions – and everyone just got it,” Lona says.
When news came in that the final patient for the study had been recruited, the team took a few hours to reflect. While there was backend cleanup work still to be done, the pace has slowed a bit.
“I think a few of us shed a tear,” Lona says. “In my small operations team, we had a short video call, and raised a glass. Then we slept.”
Other groups within Roche are asking the team for tips on best practices and lessons learned. Have they transformed the way Roche clinical trials are launched?
“That is not sustainable,” Lona says. “People ask, can we replicate this? No, we can't do what we did on a regular basis. But we can pull from lessons learned to see how we can change our processes and do things quicker, or do things differently in the future.”
You need a protocol This detailed technical document maps out how the trial will be conducted, and includes objectives, design, methodology, background, quality control and assurance, a timeline, and ethics and information on how the study will be organised and conducted. This document ensures safety for trial participants and integrity of the data and results.
Clinical Research Organisation (CRO) Roche partnered with a CRO to help navigate the exacting and document-heavy and labour-intensive process of running a robust clinical trial at great speed. CROs may help with data input, clinical monitoring systems, statistics and more.
Central Laboratory Central laboratories help compile and conduct lab tests and reports, provide randomisation systems, and arrange courier services and delivery of lab kits and biosamples to and from sites where trial participants receive diagnostics and treatment or placebos.
Clinical site selection Roche Business Insights and Analytics helped with information and projections of where the pandemic was heading, which in turn helped the study team work with the CRO to target site selection.
Patient recruitment Patients must be recruited to participate in the study based on the timeline and total number of participants stated in the protocol.
Deliver the treatment The drugs and placebos (inactive substance that looks just like the drug) used in randomised, double-blind clinical trials must be packed, labeled and delivered to all study sites under very careful care and tight timelines.
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