The COVID-19 crisis has created a critical need to support and protect people who work in healthcare and the communities they serve. The Patient Centered Outcomes Research Institute (PCORI) is funding an ambitious new Healthcare Worker Exposure Response & Outcomes (HERO) Registry, a large national community of healthcare workers. The broad goals of the HERO program are to engage healthcare workers directly to understand their needs, help set national priorities, enable access to rapid-cycle research that will enable better testing, protective medications or vaccines, and return trustworthy results or related information to participants. Working within this community, PCORnet®, the National Patient-Centered Clinical Research Network, is being leveraged to conduct an embedded randomized clinical trial sponsored by the Duke Clinical Research Institute to investigate whether hydroxychloroquine prevents COVID-19 infections.
A program as expansive and time-sensitive as HERO requires significant infrastructure and immediate action. The HERO team also needed to engage many other partners to make the program a reality in only a matter of weeks. One of these partners is Verily’s Project Baseline. The Baseline Platform, five years in development, is providing the technology base for the HERO registry and clinical trial. The Baseline Platform has been designed to support these important participant-centered communities, and will provide an engaging and secure data platform specifically tailored to the stringent requirements of clinical trials that enables direct to participant data collection and return of results.
Project Baseline has been a sustained effort to engage communities in research and support the rapid launch of clinical trials and evidence generation to bridge the gap between clinical research and clinical care. Project Baseline has multiple health system and study sponsor collaborators focused on accelerated development of new tools and interventions and has partnered to create focused registries, like Research Goes Red, a collaboration with the American Heart Association’s Go Red for Women movement to encourage more women to engage with research in heart disease. The Baseline Platform was specifically built to handle the broad variety of data types needed to both conduct complex biomedical discovery and to engage people as active participants in clinical research and clinical care. The system enables the formation of a community in a digital environment that encourages interactive participation while prioritizing privacy and confidentiality for its members.
Verily has invested heavily in the Baseline Platform to ensure it complies with multiple data privacy and security requirements and to go above and beyond the requirements of individual regulatory frameworks to appropriately safeguard user information. These standards and regulations include 21 CFR Part 11 Compliance to meet FDA requirements, ISO 27001 for security issues, the California Consumer Protection Act (CCPA) for consumer protection, and HIPAA for managing medical data in the clinical arena as it is shared among specific types of organizations. Simultaneously meeting the requirements for research registries, regulated randomized clinical trials, and clinical information flow while also maintaining a flexible system has been a worthy challenge.
- Participants’ data will only be used as specified in the protocol and informed consent form; specifically, it will not be used for advertising.
- Verily will not save participants’ data beyond the project period as reflected in the participant consent.
- Verily will not share participants’ data with anyone other than the study sponsor, the Duke Clinical Research Institute, and entities and institutions involved in the conduct of the study as directed by the study protocol. In accordance with PCORI policies and as directed by the study leadership, results will be shared with participants.
The HERO program is a noble effort that Verily hopes will meet the current need of healthcare workers—including nurses, therapists, physicians, emergency responders, food service workers, environmental service workers, interpreters, transporters and others—in the midst of this enormous crisis. Its success is dependent upon the confidence of the participants in the integrity of the study and the safeguarding of their information. Our Verily team is ready to support this study with the Baseline Platform and assist in any way possible to address COVID-19.