This morning Verily announced a series of new strategic partnerships with four global pharmaceutical companies that will bring low-burden digital data collection and analysis tools to clinical research projects.
Alongside Novartis, Otsuka, Pfizer and Sanofi, the Alphabet subsidiary will employ its Project Baseline platform to increase the number and diversity of study populations by making it easier for participants to enroll and contribute their health data.
“Evidence generation through research is the backbone of improving health outcomes. We need to be inclusive and encourage diversity in research to truly understand health and disease, and to provide meaningful insights about new medicines, medical devices and digital health solutions,” Dr. Jessica Mega, chief medical and scientific officer at Verily, said in a statement. “Novartis, Otsuka, Pfizer and Sanofi have been early adopters of advanced technology and digital tools to improve clinical research operations, and together we’re taking another step towards making research accessible and generating evidence to inform better treatments and care.”
Since 2017, Project Baseline has been employed by clinical researchers seeking to collect real-world evidence through EHRs, wearable sensors like the Verily Study Watch and other digital sources. In addition to a patient-facing ecosystem for enrollment, instruction and self-reporting, the interoperable platform includes a research decision support dashboard and analytical tools for study coordinators and other researchers.
Each of the pharmas has committed to launching new studies that will use the Project Baseline platform, according to the announcement. These will cover a range of clinical specialties — including cardiovascular disease, mental health and diabetes — and seek to partner with yet-to-be-named academic research institutions, patient advocacy groups and provider systems.
WHY IT MATTERS
Pharma’s interest in digital clinical trials has only increased with each passing year, as new platforms and capabilities promise more participants, more uniform and robust evidence, and no need for in-person protocols. And while today’s high-profile partnership announcement represents another step toward the widespread adoption of such platforms, the improved enrollment and participant experience it promises would (much like the NIH’s All of Us research program) provide a body of clinical research data that’s more representative of the general population.
WHAT’S THE TREND
Verily’s digital trial platform launched roughly two years ago with the Project Baseline Health Study, a collaborative effort with Stanford Medicine and Duke University School of Medicine. Since then, the company has established an advisory board for the platform, kicked off the Research Goes Red initiative with the American Heart Association, and just last week launched a strategic collaboration called the Baseline Health System Consortium with six academic and provider institutions: Duke University Health System, Vanderbilt University Medical Center, University of Mississippi Medical Center, Mayo Clinic, Regional Health in South Dakota and University of Pittsburgh.
One notable component of the platform is the Verily Study Watch, a prescription-only wearable device with on-board single-channel ECG that received 510(k) clearance from the FDA in January.
ON THE RECORD
“The clinical research process is antiquated in many ways. Our collaboration with Verily aims to redefine and redesign this process to make clinical trials more accessible to patients, and clinical research more precise and targeted so we can obtain results and seek approvals sooner, which would put therapies into the hands of physicians and their patients earlier,” Debbie Profit, VP of applied innovation and process improvement at Otsuka, said in a statement. “As an early adopter of the Baseline Platform, we have the opportunity to leverage real-world data, through sensors, EHR integrations and other tools to corroborate evidence around the treatments and interventions we are studying — while reducing the burden on clinical trial participants.”