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Digital Health Research Platform Set for Covid-19

Stethoscope and iPhone


20 Apr. 2020. A group of medical technology companies are forming a research platform and registry for clinical trials of Covid-19 treatments among home-bound participants. The Access project — short for American Covid-19 collaborative enabling seamless science — aims to take advantage of mobile and digital health technologies to reach large numbers of candidates for studies of Covid-19 vaccines or therapies while they’re restricted to their homes.

The initiative is led by clinical trial technology company Medable Inc. in Palo Alto, California. Medable provides digital services for recruiting and enrolling study participants, as well as collecting data through telemedicine and mobile devices. The company’s software also enables collection of clinic-based data and remote monitoring of patients, as well as integration with electronic medical records, insurance claims, and analytics programs.

Joining Medable in the project is BioIntelliSense Inc. in Denver, Colorado, developer of the BioSticker, a set of sensors in a thin, compact device worn on the chest. The BioSticker, cleared by FDA for marketing in the U.S., provides constant monitoring of vital signs, skin temperature, body position, activity levels, sleep status, gait and falls detection, and frequency of symptoms including coughing, sneezing, and vomiting. BioIntelliSense offers the BioSticker as part of a patient-monitoring service for health care providers, particularly for tracking patients in their homes following hospitalization.

Also taking part in Access is Parexel, a contract research organization in Newton, Massachusetts and Durham, North Carolina. Parexel organizes clinical trials for all phases of therapy testing, including adaptive trials that allow for modifying protocols during a study, and virtual or decentralized trials that make possible data collection from home. Another Access participant is Datavant in San Francisco, a company that collects de-identified electronic health records across data sets from 200 partners for privacy-enabled analytics, clinical trial design, fraud detection, and improved care management.

Participating in Access as well is PWNHealth, a national network of clinicians using telemedicine for diagnostic testing. The company says it works with some 45 certified diagnostic labs that support more than 3,000 different tests, producing data for patients, health care providers, and public health authorities. Joining with these companies in Access is American Heart Association’s Center for Health Technology and Innovation, whose member companies provide digital technologies addressing heart health.

The Access project aims to make it simple for individuals to opt-in for studies of their Covid-19 experiences. Data are collected through an iPhone app — no Android app is offered yet — where people will be matched, with their consent, to studies on diagnostics, vaccines, therapies, and population health outcomes for Covid-19. The project organizers say data are also collected through wearable devices. The collected data will then be integrated, again with consent, to their electronic health records for analysis.

“Access will enable us all to accelerate diagnostic testing and clinical trials,” says Michelle Longmire, CEO and co-founder of Medable in a company statement, “and advance important monitoring and immunity research, so that we can conquer Covid-19 with effective prevention and intervention strategies. By empowering people in their homes with Access, we can accelerate research by reducing time for enrollment and data collection.”

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