In the recent Veeva European R&D Summit, focus was paid to how the COVID-19 emergency and its accompanying reorganisation of healthcare provision has forced the pharmaceutical industry to rethink the way it conducts research and development.
In an exclusive interview with MobiHealthNews, Henry Levy, general manager of Veeva Vault clinical data management system (CDMS), site and patient solutions, explored what this could mean for the future of clinical trials.
Why virtual trials matter
Clinical trials are a necessary component to gaining approval for drugs and treatments, however their processes can be hugely exclusionary. “The actual study design [of clinical trials] is a high burden,” emphasises Levy. “You may have to go into a [trial] site 15 or 20 times over a six month period, every week for two to three hours. If you’re sick or elderly and you maybe live 30-40 miles away, it’s a massive burden on the patient and on the carers.”
Around 50% of these visits are not of high importance, he continues, needed only for recording vital signs or monitoring progress rather than undertaking major tests or scans.
Virtual trials could relieve some of these burdens by taking follow-up appointments to the patients rather than the other way around. “We’ve been trying to push the pharmaceutical industry and trial sites to be more patient-centric, to focus on making it easier for patients to be a part of trials and to make it less of a burden to do so,” says Levy.
They also open up the pool of applicants as the number of necessary hospital trips becomes more manageable. This could be particularly impactful for patients in rural areas and increase overall patient enrolment.
He emphasises that it is not the aim of companies such as Veeva to make all clinical trials completely virtual, however, suggesting that only 5-10% of clinical trials even have the capacity to be completely virtual. “We don’t want this to be the ‘new normal’,” Levy states. “We don’t want every visit to be virtual [but] we’re creating proof points that if we have to do 100%, we probably could, and therefore what we’re asking for is much less.”
Virtual trials and COVID-19
Although acknowledging increased interest in the possibilities afforded by virtual trials, Levy was cautious not to exaggerate their uptake. “The push for virtual visits has been going on for 10 years and I would say that less than probably 0.1% of visits today [before COVID-19] are virtual,” he states. “You still have people entering information into a piece of paper and then providing it to the pharmaceutical company for their assessment.”
This circuitous method of data sharing continues because EHRs and EMRs are not built to capture clinical trial or other research data. Much like the pre-pandemic reluctance to truly exploit the potential of telemedicine as a primary means of healthcare provision, the lack of reliable research-sharing structures underlines a prior lack of enthusiasm to modernise healthcare at an institutional level.
The COVID-19 pandemic, however, significantly impacted the mindset around healthcare provision, particularly surrounding telemedicine, with necessary restrictions to face-to-face contact dispelling earlier apprehensions.
Clinical trials, though, have not been able to adapt in the same way.
“Usually there are around 4,000 new clinical trials per year and about 1,000 trials stopped [because of the pandemic],” discloses Levy. The crisis hindered companies from enrolling new patients onto trials and they faced increasing difficulties in continuing visits with existing participants as it might not be ethically appropriate. This, Levy fears, will have led to many protocol deviations, locking participants out of trial findings and therefore losing a substantial part of the trial’s research data, potentially invalidating the study altogether.
“I would say at least 15 pharmaceutical companies said that they would actually not start any new trials other than COVID-related ones.”
Companies such as Veeva tried to redress this issue by developing and providing remote monitoring solutions to pharmaceutical companies whose trials were close to submission for FDA approval, though Levy notes this benefited only a small percentage of the affected studies.
The positive impact of the pandemic
Levy acknowledges that strides have been made during the pandemic, citing regulators and the FDA creating incentives and recommendations for disruptive technologies such as eSource and virtual trials.
“I’m incredibly optimistic that this can be a catalyst for positive.”
Levy outlined what the acceleration of virtual trials would require logistically, laying out four key components: technology, institutional acceptance, home health and clinical trial supplies.
Ensuring patients have appropriate technology to participate in trials is a small task that, Levy reckons, is easily overcome providing there is the backing by sites and pharmaceutical companies; historically, this has been hard to come by but that has been fundamentally changed since the crisis. The pandemic has also revolutionised home healthcare networks, providing solutions for remote testing and monitoring as never before.
Clinical trial supplies, on the other hand, are logistically much more difficult as they essentially put the control of the trial in the hands of the patients. It involves control of the drug, the randomisation component, security, refrigeration/storage and maintenance. “There is still some work to do around the clinical trials supply, the drug supply logistics, which I think are hard to do without the site. There are ways but this is where we still need some evolution.”
Levy thinks this will need both physical and technological advancement in virtual trials, but, with interest expressed from across healthcare - pharmaceutical companies, health tech innovators, national care providers and hospital administrators - virtual trials appear to have a bright future.