Applied Clinical Trials
Medable Inc. has announced a multi-company research framework to accelerate development of diagnostics and treatments for COVID-19, providing individuals access to participate in research for diagnostics, health monitoring and interventional clinical trials. The ACCESS initiative-short for American COVID-19 Collaborative Enabling Seamless Science-provides a mobile consumer application and secure infrastructure to connect health researchers and clinical trial teams with up to millions of home-bound individuals in the United States.
ACCESS makes it so individuals can contribute specific information about their COVID-19 experience, combine it with health records and data from wearable devices, and opt in to participate in current and future studies for diagnostics, treatments, and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale.
ACCESS is a collaborative effort led by Medable, together with technology, healthcare and life sciences companies including BioIntelliSense, Datavant, Parexel, PWNHealth, and the American Heart Association’s Center for Health Technology and Innovation. ACCESS takes full advantage of mobile and digital health technologies to facilitate at-home research, clinical trial access, and population-based long-term outcome studies. The infrastructure combines medical-grade wearable sensors, patient-reported data and outcomes, historical health data and health record aggregation. Participants opt in at every stage, so they maintain control over their personal health data-and decide how they want to engage in potential studies.
“ACCESS will enable us all to accelerate diagnostic testing and clinical trials-and advance important monitoring and immunity research-so that we can conquer COVID-19 with effective prevention and intervention strategies,” said Dr. Michelle Longmire, CEO and co-founder of Medable, which built the mobile application and digital infrastructure for ACCESS. “By empowering people in their homes with ACCESS, we can accelerate research by reducing time for enrollment and data collection.”
ACCESS provides screening, disease and immunity status testing, and general lab testing to qualified participants through PWNHealth’s national network. “This is a pivotal point in the pandemic and PWNHealth can play an essential role in the ACCESS program, leveraging our national clinician network, telehealth capabilities, and laboratory partnerships to enable patient access to testing at scale,” said Sanjay Pingle, CEO, PWNHealth.
ACCESS enables vital sign data collection via smart watches including the Apple Watch, as well as continuous health monitoring through FDA-cleared body-worn sensors from BioIntelliSense. “We are honored to combine forces with leading industry organizations and apply our advanced biosensor technology and medical-grade data services to research COVID-19,” said James Mault, MD, CEO of BioIntelliSense. “The FDA-cleared BioSticker device can play a key role in infectious disease monitoring by enabling effortless and continuous data capture of multi-parameter vital signs.”
ACCESS enables participants to provide researchers access to de-identified health records, claims, diagnostic and other data sources via Datavant’s data infrastructure. “Accelerating the pace of clinical development will help patients get access to life-saving therapies more quickly,” said Travis May, Datavant CEO. “We're excited to help power ACCESS and accelerate clinical trials by making it easier to connect to the ecosystem of real-world data.”
ACCESS removes key bottlenecks in research, making it easier for clinical trial leaders to recruit and monitor patients, while shortening timelines for diagnostics, treatments, and vaccines. “We have seen a rapid response from the pharmaceutical industry to the COVID-19 crisis, with hundreds of clinical trials underway in a remarkably short period of time,” said Jason Martin, Senior Vice President, Global Data Operations, Parexel. “The next challenge is connecting patients to these studies, which is particularly difficult in this fast-changing situation. Fortunately, we have access to more data as well as innovative ways to de-identify and link that data to help connect the right patients to the right studies. We look forward to working with the ACCESS study team to harness that connectivity to bring hope to patients in need.”
The American Heart Association played a valuable role in helping Medable bring together various parties to contribute to ACCESS. “Connecting innovative companies in health tech is a big part of what we do at the Center,” said Patrick Wayte, SVP, American Heart Association Center for Health Technology and Innovation. “Convening parties to develop novel ways of improving clinical care and research, with the ultimate aim of improving patient outcomes, is a core philosophy of the Association. We see that digital healthcare solutions can play a huge role in the transformation of medicine, and we’re glad to help catalyze these changes.”