Outsourcing
Then Covid-19 hit. Lundbeck’s preparation and research came into play, and “gradually and slowly” went out the window. While other companies were starting from scratch, Lundbeck set about putting existing plans into action.
“First, we had to make workarounds and do what we could to get trials going. We were forced to change from physical visits to some remote visits, and some of the outcome assessments that were previously done by the physician and the patient interacting were replaced by phone calls or remote assessments,” says Dalsgaard. “We knew before that there was potentially a lot of value in this way of working, but we didn’t really have the data. Now, we were forced to do it and it really enabled some trials to get going.”
The new ‘norm’
As the Covid-19 emergency eases, the company is now pushing ahead with its decentralisation agenda in an effort to make virtual trials the ‘norm’. “We have identified the first trials to not fully decentralise but to ‘hybrid decentralise’. We take each trial and say, ‘which are the visits that would normally require the patient to come into the clinic? Can we enable this within the home of the patient?’ “With our earlier preparation work, we already had a good understanding of vendors, we already had elements of the infrastructure, we had already worked with digital inputs. So, we had a head start. Now, we’ve done formal mapping around it. There are still a few gaps – for example, around consent – but we know what the ecosystem will need to be in order for us to be 100% virtual. We are using trials one at a time as vehicles to drive closure of those gaps.”
“My sense is that all our clinical trials will now more or less have elements of decentralisation in them.”
Dalsgaard says each trial is used to build knowledge in this way. “We had one trial that was struggling with enrolments, so we did a deep dive – almost an anthropological approach – and, working with a vendor, mapped the journey for patients, caregivers and investigators. We mapped the pain points and the motivating aspects of the trial for these key stakeholders, and it was really revealing.” He says the benefits to patients of virtual trials are clear, especially in terms of cutting logistics and travel time. This is significant given the high number of trials that fail to recruit enough patients for day one. “Enrolment is nuanced in terms of access to patients, especially in rare diseases, where the likelihood that you have a high enough concentration around a few sites is low. It’s also about retainment
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within the trial – ensuring that patients are not surprised by the burden,” he says.
Push forward
Dalsgaard is also excited about improving the quality of data, especially given the push from both industry and regulators towards patient-reported outcomes. “You could argue that a patient-reported outcome better captures the benefits to the patient,” he says. “How accurate is assessment number five after a long day if you’re assessing memory or mood? With decentralisation, instead of just relying on that one single time point, you can assess something three times a day. Some of these measures can almost be continuous. There’s a lot more burden on the analysis, but that gives you a wealth of information and much more richness in terms of what the molecule can do.”
The move to an online or home-based environment is not, however, without its challenges, particularly in terms of investigators. “For some investigators, it may not be easier. It may in fact be easier for them if the patient was there physically, rather than having to use a more cumbersome approach through video or other interactions,” says Dalsgaard. “We have had examples where some investigators have declined to join a trial or where some of the hybridisation or decentralisation needs to be optional for the investigators in order to keep them. I think there needs to be a lot of learning on our side and in collaboration with investigators to find a good model where they also get the benefit of that extra work.” He said finding a balanced approach would
be key. “I hope and I expect that we’ll see more decentralisation, but we still need to refine the model. We need to ensure that we’re not relieving burden on patients and then unloading it on top of the investigators.”
Even so, Dalsgaard says virtual trials in the post- Covid-19 world have moved beyond the point of no return. “My sense is that all our clinical trials will now more or less have elements of decentralisation in them.” He predicts, however, that few trials will become fully decentralised. “Depending on the phase of the trial and the nature of the disease or the molecule, we will need to sometimes have the patients come to the clinic – we’re using home nursing to take blood samples, but there are obviously assessments like PET scans and MRIs, and things like that where you need the patient to come to the clinic. “I think if I look within our own portfolio, the likelihood, at least in the earlier phases, that you can do 100% decentralised – I think that is far-fetched. It’s the hybrid model, which, in my mind, gives a good balance between really taking care of the safety and minimising risk, but at the same time also relieving
Clinical Trials Insight /
www.worldpharmaceuticals.net
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