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By Jacqueline Lisk
Before COVID-19, the clinical research world was “stuck in an old mindset that participation had to be in person,” explains Martin Naley, a Boston-based entrepreneur and clinical informatics specialist at Ciitizen, which gathers and structures medical records for patients and connects them with treatment and research options.
Patients pursing clinical trials sometimes need to travel far from home to meet in-person requirements. For instance, “I know a patient who lives in Florida and traveled to New York City on a monthly basis to pick up her clinical trial medicines in person,” Naley says.
For people with fewer resources, participating in that kind of long-distance trial would be next to impossible. But due to COVID-19-related protocols, in-person clinical research wasn’t always possible over the past year, forcing researchers to embrace a trend already underway: the rise of decentralized trials, in which researchers use technology to facilitate participation outside of clinical settings.
“Prior to the pandemic, the pharma and biotech industry had been kicking around the concept of hybrid and decentralized trials for quite some time, but very little had been done to advance that approach. COVID-19 changed all that,” says Karen Currie, MPH, executive director of Citeline Editorial at Informa Pharma Intelligence. “Suddenly, this wasn’t a concept to pilot on a small future study, but a necessity to keep essential clinical drug development from stalling.”
Unfortunately, preventing drug development from stalling wasn’t possible in all cases. Accenture found that 77% of patients had its clinical trials delayed or suspended due to COVID-19. For those patients who were able to continue, 61% used virtual forms of communication.
For COVID-19 vaccine research, virtual communication and digital tools were essential to progress. Aaron Hartman, MD, a practicing clinician in Midlothian, Va., and principal investigator for the Pfizer COVID vaccine trial, says using digital tools during vaccine research accelerated processes and enabled collaboration with professionals all over the world.
“With COVID-19, everything has been digital: medical reviews, digital management systems — even people entering the data have been virtually located out of state,” Hartman says. “We’ve been able to conduct a study with over 400 participants using only three on-site staff members. This would have been unheard of even two or three years ago.”
Hartman believes metadata — the collection of data that helps describe other data — is here to stay. He cites the COVID-19 symptoms tracker app as an example, which was a collaborative effort between Massachusetts General Hospital, the Harvard T.H. Chan School of Public Health, King’s College London, Stanford University School of Medicine, and ZOE, a health science company. Using the app, more than 4.6 million people have voluntarily shared symptoms of the disease.
“We’ve been able to track over 200 different symptoms related to COVID-19 from this simple app that took a small research company five days to put together,” he says. “In a university setting, it would have taken six to twelve months to get even the app approved through administration.”
Data collection is just a part of the puzzle — life scientists also need tools to glean meaning from the information they have gathered. To manage data from multiple sources, and multiple trials, Moderna used the clinical trial technology platform Medidata, a Dassault Systèmes company.
Medidata co-CEO Glen de Vries explains the platform “creates the data fabric that brings everything in the clinical trial together,” including data collected by physicians, nurses, coordinators, and administrators across study sites. In the case of Moderna, the platform also integrated data from patients, as participants used an app on their phone to report COVID-19 symptoms.
A patient-centric future of research
Many of the adjustments researchers were forced to make during the pandemic resulted in patient-centric trial design. Patient-centric clinical trials are intended to be as convenient and engaging as possible. For example, using remote monitoring tools reduced the number of in-person visits required and made patients feel more cared for and understood.
Drugs developed using patient-centric clinical trials are 19% more likely to launch, according to data from Parexel, a Boston- and Durham, N.C.-based biopharmaceutical services company. In addition, these trials take less time to recruit the first 100 participants: four months versus the all-trials average of seven months. It is possible that people may be more willing to volunteer for clinical trials as a result of COVID-19 vaccine development. Combining this sentiment with the benefits of patient-centricity could dramatically speed up clinical research timelines going forward.
“When we did the Pfizer C. Diff vaccine [an investigational vaccine for the prevention of Clostridium difficile infection] study, it was about two years before the trial was filled,” says Hartman. “However, with COVID-19, we were filling up trial sections in four to six weeks due to the huge desire for participation. COVID-19 has opened the eyes of the public to the value of clinical research involvement and encouraged mass swathes of people to be involved in clinical research.”
Patient-centric decentralized trials may also lead to more equitable and diverse clinical research, as it is easier to engage participants from all regions and socioeconomic backgrounds.
“Clinical trial sites are often academic medical centers led by key opinion leaders in their field. The patients walking through the doors of those medical centers are probably from a very specific socioeconomic and demographic group,” de Vries explains. “Then you wind up with this bias [in the] data set.”
Using a decentralized approach, “you can find patients who could benefit from your therapy potentially anywhere, then build the infrastructure around them,” de Vries says.
That said, you still need community outreach to find and engage participants. Moderna used crowdsourcing to help recruit patients for its COVID-19 vaccine trial. To meet its diversity goals, the company worked with a platform, TrialScope Connect — now called Citeline Connect — that helps recruitment partners refer potential study subjects to research sites.
“The platform’s embedded pre-screening tools helped streamline the process, qualifying leads, and helping Moderna achieve its goal of a diversified study population with more than 11,000 people from communities of color,” Currie notes.
The clinical research space has made progress. But what happens when the pandemic and social distancing are behind us? There is hope the biopharma community can apply lessons learned developing a COVID-19 vaccine at record speeds to advance research in other disease areas.
“I have every expectation that industry leaders and their regulatory counterparts will continue to collaborate and expand upon the initiatives undertaken during COVID-19 to help improve clinical trial efficiency, and to adopt measures that promote convenience for trial participants,” Currie predicts.
“In fact, there is a strong movement afoot – #nogoingback – comprised of life science professionals committed to retaining the progress made and driving future practices to make clinical research more efficient and accessible for all,” she says.