Remote research: Life sciences adapts to clinical trial disruption
INSIGHT ARTICLE |
Massive pandemic-induced workplace disruptions and social distancing protocols remain a challenge for businesses in multiple industries, but companies in the life sciences space have found themselves in an especially unique position: Researchers must simultaneously work at a rapid pace to develop a vaccine and treatments for COVID-19, support previously scheduled and ongoing clinical trials, manage restricted access to labs and research facilities that are crucial in making such innovations possible, and support the safety, engagement and enrollment of patients at trial sites.
It makes sense, then, that a company whose product is a virtual research and development marketplace has seen interest in its platform surge during the pandemic. Scientist.com describes itself as the “world’s largest AI-powered marketplace for medical research,” a resource that connects scientists and helps organizations effectively manage their outsourced R&D and manufacturing.
A tool that may prove particularly useful in scientists’ efforts to monitor the impact of COVID-19 on the research and trials landscape is Trial Insights, a database that launched in 2019 and is available on Scientist.com. Trial Insights collects real-time clinical trial submissions to provide curated reports on trends of trials happening globally. Information about trials related to COVID-19 is currently available for free; users can pay a fee to access information related to trials for other therapeutic indications, said Scientist.com CEO Kevin Lustig.
A dashboard view of Trial Insights data on clinical trials related to COVID-19. Source: Scientist.com and Trial Insights.
As the global coronavirus pandemic intensified months ago, clinical trials for COVID-19 vaccines and treatments exploded: Activity spiked in April, with about 1,423 new registered trials related to the disease, noted Lustig, followed by 1,136 more in May and 740 in June.
"I think scientists really stretched to try to figure out how to develop new vaccines and treatments quickly,” he said. “It’s remarkable how fast it went.”
Though this spike has subsided and there are now a few dozen front-runners racing toward a vaccine, the rest of the life sciences ecosystem faces new challenges for existing or soon-to-launch trials for non-COVID-19 diseases. According to Lustig, there wasn’t a slowdown in the overall number of clinical trials during the height of the pandemic; historically, there are roughly 1,300 ongoing trials globally in any given week and today’s level is roughly the same, according to a Scientist.com analysis of recent data. But what was significant was just how many of those trials were related to COVID-19.
“At the peak, COVID-19 trials accounted for one quarter [of all trials],” Lustig said. “Which means that March through June, other clinical trials were put on the backburner.”
The pandemic resulted in hundreds of trials related to a range of other diseases getting put on hold, NPR reported in April. There has been a global resumption of trials since then, but given that the largest disruptor to clinical trials is a failure to meet recruitment milestones, it is likely that the United States will continue to see the resumption of trials lag until our coronavirus case counts decline and the economy reopens more broadly.
COVID-19's disruption in the life sciences space hardly stops with clinical trials, however. Companies have also had to grapple with supply chain issues that have led the industry to question whether and how to repatriate parts of supply chains back to the United States, Lustig remarked.
To remain resilient and relevant as the pandemic continues, life sciences companies should embrace a virtual research model, Lustig said. Doing so would allow scientists to continue making research progress even if another wave of lockdowns and stay-at-home orders occurs.
Biotech, pharma and medical device companies should also diversify their supply base and develop backup plans for how to adjust operations if laboratories are inactive or operating at a reduced capacity or if supply chain issues reoccur. For pharmaceutical and biotech companies that may have experienced a temporary lab closure due to the pandemic, Scientist.com allows the flexibility to continue experiments remotely: The platform enables researchers working from home to order complex technical lab services from over 3,400 pre-contracted CROs, most of which have stayed open during the pandemic. The platform also helps biotech and pharmaceutical companies find nearby suppliers to work with, as opposed to sourcing from China or India.
“There is an enormous trend to outsource drug R&D,” said Lustig. “When I started the business [in 2007], 10% of total R&D budgets was being spent on outsourced work. Now, it’s 50%.”
Along with diversifying supply chains, Lustig encourages life sciences companies to focus on advancing preclinical research programs. That way, there will be other non-COVID-19 drug candidates ready to enter the clinical pipeline in the future—once a vaccine for the coronavirus is available.
"It's about doubling down on preclinical research now and investing in the future despite the fact that we’re in a pandemic,” Lustig said.
Drug development and tangible supply issues aren’t the only issue researchers have to contend with. Teams are persevering and adapting to the new normal, Lustig said, finding ways to operate remotely on tighter timelines and thinner margins while maintaining a collaborative culture that brings projects to fruition. This is one example of how the life sciences industry has continued to demonstrate its ability to research and innovate in the face of unprecedented global challenges.
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