Clinical Trial Professionals Come Together in New Ways to Battle COVID-19

Amanda Wright, BS, Vice President of Partnership Development, Javara Research

Clinical trial practitioners and the broader industry continue to answer the call to battle COVID-19.

Earlier this week, Wake Forest Baptist Health (WFBH) joined forces with clinical research organization Javara Inc. to conduct a community-based research study of the novel coronavirus. “It’s another example of how we as an industry are finding new and more effective ways to collaborate” to battle COVID-19, says Amanda Wright, vice president of partnership development at Javara.

WFBH and Javara have collaborated with Oracle to develop the technology giant’s Patient Monitoring System, a web portal designed to collect daily information across a large population of participants.

Atrium Health, one of the largest health systems in the Southeast, and MedStar Health, the largest healthcare system in the Maryland and Washington, D.C. region, have joined the project. Plans are under way to extend this research study to additional health systems across the country.

The goal of the study, which will employ online data-gathering and at-home rapid diagnostic kits and began enrolling patients last week, is to help the medical community better understand the pandemic and regional infection patterns as it develops strategies and treatments to contain and possibly eliminate this novel coronavirus in defined communities.

“This study should rapidly allow us to define the epidemic on a regional basis and establish the framework to both track the disease in real time and answer critical secondary research questions,” said John W. Sanders, MD, principal investigator of the study and chief of infectious diseases at WFBH.

All data will be shared in real time with appropriate government agencies, such as the federal Centers for Disease Control and Prevention, National Institutes of Health, and state and local public health departments, Sanders said.

Separately, the EndPandemic National Data Consortium announced on April 14 that it had received commitments from six leading life sciences and information technology companies to join the consortium. The companies will work together to integrate data from all ongoing and future clinical studies to dramatically accelerate analysis on COVID-19 and SARS-CoV-2 research.

The organizations are:

  • Andaman7 has built a COVID-19 patient symptom survey with electronic health record (EHR) and device integration. Andaman7 is helping patients understand their COVID-19 risk through easy symptom tracking and information. The platform is HIPAA, GDPR, and 21 CFR Part11 compliant, and is available in 22 languages. Andaman7 enables proper privacy controls by patient via recurring consent, and offers the ability to collect patient-reported, device, and electronic medical record (EMR) data. Their advanced technology delivers information and guidance to patients, and provides access to more than 10,000 clinics and hospital EMR systems in the U.S.
  • Caprion Biosciences Inc. is a leading provider of specialized immunology, genomics, and proteomics laboratory services to the pharmaceutical and biotechnology industry. Caprion’s advanced immune monitoring services include phenotypic and functional analyses of innate and adaptive immune responses in patients treated with innovative immunomodulating drugs and vaccines. In addition to deep expertise in the development and clinical deployment of laboratory assays and tests, Caprion’s data integration and biostatistical analyses of large datasets enable partners to decipher the most optimal treatment combinations and vaccine strategies using a biomarker-driven approach.
  • Clinerion operates a global patient data network platform, Patient Network Explorer, which currently has near-real-time access to the EHR-based data of more than 27 million patients. The platform enables flexible queries of demographic data, diagnoses, medications, procedures, and laboratory results, and includes event-based and temporal constraint capabilities. Clinerion supports research and real-world evidence queries for COVID-19 cases, epidemiology, and health economics and outcomes research. Clinerion can track and analyze complex combinations of patient data longitudinally, to understand patient treatment diagnostics, treatment modalities, co-morbidities, and developing cohort and outcome models by country and healthcare institution. Clinerion works with its partners and hospital networks to support the community, enable patient outreach, and facilitate longitudinal epidemiological studies.
  • INDX.AI is a Silicon Valley-based data analytics software company that provides end-to-end solutions to accelerate translational research in precision medicine-based clinical trials using biomarkers and AI-enabled multi-omics data analytics. Its award-winning iCore Platform is being adapted to help speed up translational research with in silico biomarker discovery for COVID-19 clinical trials.
  • Saama Technologies’ AI-powered Life Science Analytics Cloud (LSAC) technology platform will empower researchers around the world to dynamically visualize, analyze, and interrogate data across all available programs. LSAC seamlessly integrates, curates, and animates clinical trial data, delivering more actionable insights for faster decision making. Additionally, Saama has already leveraged LSAC’s deep learning capabilities to enable queries of the COVID-19 Open Research Dataset (CORD-19), a publicly available database that contains more than 45,000 scholarly articles about COVID-19 and is intended to help the medical community keep up with the latest research and find the most accurate answers to questions related to the virus and its impact.
  • Zaylan Associates (in partnership with Chrysalis Biomed Advisors) is a strategy consulting firm with focus on digital transformation of life sciences companies spanning large global corporations to startups in such areas as pharmaceutical/biotechnology, medical technology, and diagnostics development, and providers of health information, information technology, and healthcare services.

Author: Michael Causey