Current Health, a remote patient monitoring platform, has launched Community, its latest initiative to build diverse longitudinal datasets for decentralized clinical trials.
Using its FDA-cleared remote monitoring system, Current Health collects hospital-level data such as respiratory rate, heart rate, temperature, oxygen saturation and movement without asking the patient to leave home. The system can integrate other monitoring devices, such as those from VivaLNK, Dexcom and Omron.
“Data is key to understanding how diseases present and evolve across populations,” said Dr. Stewart Whiting, cofounder and chief technology officer at Current Health, in a statement.
“With our technology, we have the ability to collect massive amounts of data within the context of a patient’s day-to-day life, allowing us to create more diverse, representative clinical datasets. By collecting more and better population data, we can enhance our understanding of disease and enable early delivery of preventive treatments at home that benefit all people.”
To support decentralized trials, the company supplies patients with everything they need to participate, including a tablet to record daily activities and symptoms, as well as Internet connectivity.
WHY THIS MATTERS
In the age of COVID-19, conducting in-person clinical trials is nearly impossible. With participants unable to physically visit clinical trial sites, researchers have had to shift the way they conduct studies, often opting for a remote design.
In fact, 76% of researchers are now running decentralized trials because of the pandemic, according to a survey conducted by Oracle.
Remote clinical trials have also played an important role in understanding the coronavirus and getting a vaccine on the market.
Community hopes to build on that work by launching its own COVID-19 study, which aims to predict hospitalizations and inform clinical treatment.
It is currently enrolling U.S. participants who have been diagnosed with COVID-19 in the last 48 hours. Interested participants can fill out an eligibility form to enroll in the 30-day study. Upon completion, participants return the equipment and they will receive $100 for their time.
THE LARGER TREND
While remote clinical trials allow for broader recruitment and lower associated costs, there is concern that using consumer-grade products to collect data is not as effective as using medical-grade products, according to a Nature report.
Even so, interest in the space is growing. Labcorp recently launched a technology platform for its drug development and decentralized clinical trial business, Covance. Unlearn, a startup creating digital twins used in the control arm of clinical trials, raised $15 million last year. Its machine learning model generates an intelligent control arm that can reduce the sample size and decrease the number of participants given the placebo.
The Decentralized Trials and Research Alliance was also created towards the end of 2020. It is made up of more than 50 life sciences and healthcare organizations, including AstraZeneca, the U.S. Food and Drug Administration, and Pfizer. It plans to unite stakeholders across the health spectrum to further policies, research practices and technology innovation for decentralized clinical trials.
ON THE RECORD
“People are desperate to help in the fight against COVID-19, but many don’t know how,” said Adam Wolfberg, chief medical officer at Current Health, in a statement.
“If you are diagnosed with COVID-19, sharing your health data is one of the most impactful ways to contribute to lifesaving research. It has never been easier to participate in clinical research, and we are proud of how Community will expand the opportunity to meaningfully contribute to science.”