In a public health crisis, healthcare providers are the heroes and lifesavers. And for those battling COVID-19 on the front-lines, reliable information–about virus transmission, pathology, and optimal intervention–is critical to ending this pandemic sooner rather than later. But disinformation can spread faster than the virus itself. Therefore, it’s critical that an intelligent approach be taken when prioritizing and sourcing patient data for surveillance testing and clinical research studies.
Although the COVID-19 pandemic has sent the world sideways and shut down entire sectors, the healthcare industry got to work—rapidly reconfiguring operations, adjusting supply chains and mobilizing medical teams. While many of these initial efforts are focused on the acute clinical challenges of disease diagnosis, treatment and suppression, the next major challenge is population-wide surveillance in parallel with integrated clinical research; the very type of research that will ultimately lead us to a breakthrough. More importantly, that type of research may also provide a turnkey option for future public health crises.
For COVID-19, the timing of syndromic testing, serological testing and data analysis is critical. Testing is by no means a commodity and remains a scarce and valuable resource. For this reason, population prioritization should be implemented with high-risk sub-groups as the first priority. We already know that asymptomatic individuals are infectious, and we also know that the strongest period of infectiousness is immediately following onset. So as the remaining population awaits testing, it’s critical that symptomatic individuals act immediately upon symptom onset.
To prevent further transmission once symptoms occur or a diagnosis is confirmed, clinical sites require near real-time testing and analysis, as well as the ability to communicate test results rapidly. This prioritized testing and analytics approach is currently operational and can be implemented to nationwide healthcare systems and their industry partners right now.
One medical center already taking this approach is Wake Forest Baptist Health, and it will soon be followed by its regional partner, Atrium Health. Collectively, these healthcare systems have a patient population in excess of twelve million, all of whom are potential participants for the COVID-19 Community Research Project. In partnership with Oracle, this community-based surveillance study establishes a framework for real-time disease tracking, which will provide regional epidemiological data on the pandemic, and provide a mechanism to answer secondary research questions.
Javara and Wake Forest Baptist Health have been collaborating closely with Oracle to design a web-based patient portal known as the Patient Monitoring System. The system prioritizes and aggregates patient test data and provides real-time analytics on regional infection patterns—data which can then be disseminated to federal, state and local agencies almost immediately.
The Patient Monitoring System’s online portal enables patients to submit syndromic testing answers, and a companion mobile app helps guide serological testing after a kit is mailed for in-home screening. In a great example of applying technology to healthcare, the app enables patients to send blood images back to the system’s Artificial Intelligence engine digitally, where test results are automatically generated. Similarly, all surveillance testing data is also fed into the system’s analytics engine, where various reports and statistical visualizations highlight trends and correlations between symptom, contact and time dimensions.
Integrated Clinical Research
While the Patient Monitoring System is focused on surveillance, a second system, the Therapeutic Learning System, is focused on acute intervention for patients testing positive for coronavirus. This system collects real-world data regarding prescribed treatments and allows healthcare providers to study outcomes using automated analytics—thus helping to inform clinicians and researchers as to the optimal treatment, dosage and timing of administration.
Data generated by these two systems are also integrated with the healthcare providers’ Electronic Health Record (EHR) systems. While naturally critical for surveillance studies and intervention, real-world EMR data is equally critical for enabling much-needed clinical research that will eventually lead to effective therapies or a vaccine.
Again, the fight against this pandemic will be won through information. Accurate information. Actionable information. Information that initiatives like the COVID-19 Community Research Project will provide to clinicians, researchers, and policy-makers.
Javara, Inc., an Integrated Research Organization (IRO), integrates with healthcare systems and provides an advanced clinical research infrastructure to conduct clinical trials. As a clinical research site provider, Javara works with CROs, biotech and pharmaceutical companies providing a direct-to-patient model that is centered on improving patient access where physicians and investigators can offer clinical research as a care option.
Javara and its healthcare partners offer a more efficient and effective site solution for conducting clinical trials with embedded staff, resources and technology. This provides key benefits like rapid site activation, enhanced enrollment and retention, access to diverse patient populations, EHR data for protocol matching and enhanced patient experience. Javara is integral to the advanced care offered by its healthcare partners and dedicated to advancing drug development across all therapeutic areas with improved outcomes for all.
Joseph Scott, Senior Director of Technology, Data & Analytics