For Medidata, the impact of the pandemic became clear when doctors and nurses working on clinical trials stopped entering data.
“Things got real quiet,” said Glen de Vries, co-CEO of Medidata. “Evidence generation wasn't happening.”
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Medidata is a life sciences software provider that supports clinical trials with a primary focus on evidence generation. The company has counted Novartis and Tesaro as clients, among other large and small pharmaceutical companies and biotechs. Medidata's cloud platform was used in the clinical trials for Moderna's COVID-19 vaccine.
So when companies suddenly had to figure out a way to quickly take their clinical trials virtual during the pandemic, Medidata was one of their first calls. De Vries said his company works on decentralized trials and some of the many solutions companies adopted to complete their research.
“All the stuff has been around, [but] nobody really realized how important it was until all of a sudden, regardless of what therapeutic area you were in, patients weren't coming in for the clinical trials,” de Vries said. “So participation just went effectively to zero, because people didn't want to or couldn't go to the clinics where these clinical trials were being run.”
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Medidata got to work setting up ways for patients to report symptoms and reactions on their phones, connecting people who administer clinical trials with clinics that were still operating virtually and providing guidance on how to ensure decentralized trials are done right.
The company also compiled data from client companies to develop reports that could inform the entire industry as they worked through all the struggles of the pandemic.
“The more people could see what was going on around them the better,” de Vries said. “You don't want a company like Novartis to only know what's happening in Novartis.”
Companies were becoming increasingly worried about how the clinical trial delays were going to affect their financial well-being in April 2020, according to Medidata's report. Two-thirds of respondents said they had already halted patient recruitment for ongoing clinical trials, or would soon. By August, the situation was improving, but delays were still happening. The report found a 20% decline in new patients entering clinical trials globally at the end of August 2020 compared to before the COVID-19 pandemic, according to the September edition.
"In positive news, sponsors and sites continue to adapt to the new normal that COVID-19 has imposed," the report said. "COVID-19 is enabling—actually, forcing—aspects of clinical trial management that have been in discussion for decades."
An emergency cord
Not all virtual tools can be used for every trial, and some clients could not suddenly go virtual. The results of that were obvious as company after company canceled or stalled their trials.
“It wasn't like it was an emergency cord you could pull and save these trials. Unfortunately, I think a lot of people wound up losing a lot of time, evidence generation,” de Vries said. “The sad thing about that is, the knock-on effect is that their patients are gonna be waiting that much longer to get some breakthrough medicine.”
Companies that already had virtual trial capabilities—or had at least been considering adopting technology to streamline research—did the best when the pandemic hit. Now, de Vries is hoping drug companies will take a hard look at what they learned to plan for the next disruptive event.
“Now I think the Novartises of the world … are realizing and implementing stuff themselves—and with companies like us—that let them scale those ideas,” de Vries said. “I think we are settling into what I hope is a new normal.”
Medidata itself is capitalizing on the renewed interest in decentralization and virtual trials. The software company rolled out a decentralized technology platform in June that supports remote patient participation, sponsor oversight of patient safety and data quality, and drug delivery to patients' homes. And the company is facing plenty of competition from smaller clinical trial software companies hoping to cash in on the new rush to virtual trials.
Decentralizing trials is unlikely to make clinical research cheaper, at least in the near term. De Vries said using virtual tools can make the studies more complicated while still benefiting patients and the overall research.
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Medidata and contract research organizations exist to connect pharmaceutical companies with the doctors and nurses who run the trials on the ground. Those healthcare workers do not work for the companies, and their main priority is caring for their patients. Once patients are responsible for punching in their own data, the research gets a bit trickier.
Now, the pharmaceutical and biotech industries need to create the infrastructure to allow patients to be enrolled whether they are at home or able to come into a doctor’s office as well as wherever in the world they happen to be.
“If I can find patients faster, I can generate evidence faster. I can get a regulator to approve my drug faster. I can get that drug out into the market faster,” de Vries said. “This is an ethical and a commercial win.”