“As the number of COVID-19 cases across the country grew, numerous pharmaceutical companies and other institutions reached out to Geisinger, hoping to collaborate on clinical trials and other research efforts,” explains David Ledbetter, PhD, executive vice president and chief scientific officer for Geisinger. “I realized early on that Research should participate in these efforts. The question became how to vet the opportunities for collaboration. That’s why we formed the COVID-19 Research Oversight Committee.”
The COVID-19 Research Oversight Committee brings together leaders from Geisinger’s Research Institute, Clinical Enterprise and Steele Institute for Health Innovation to coordinate and prioritize COVID-19-related research proposals, whether they come from inside or outside of the organization.
The committee is cochaired by Eric Wright, PharmD, director of the Center for Pharmacy Innovation and Outcomes, and Michelle Meyer, PhD, JD, associate director of Research Ethics for Geisinger’s Center for Translational Bioethics and Health Care Policy, with Candice Laubach, associate vice president of Research, serving as administrative lead. Other members of the committee include:
- Alison Brodginski, DO Infectious Diseases Specialist
- David Carey, PhD Chair of Molecular and Functional Genomics
- Navneet Dang, MD Chief Quality Officer of Inpatient Services
- Sarah Evans, DNP Cochair of Nursing Research Council
- Deb Henninger, RN Director of IRB Operations and Human Research Protection Program
- Les Kirchner, PhD Chair of Population Health Sciences
- Chadd Kraus, DO, DrPH Emergency Medicine Specialist
- Joseph Leader Associate Vice President of Research Informatics
- David Ledbetter, PhD Executive Vice President and Chief Scientific Officer
- Stanley Martin, MD Director of Infectious Diseases
- Anthony Petrick, MD Chief Quality Officer of Inpatient Services
- Alanna Rahm, PhD Associate Professor of Genomic Medicine Institute
- Paul Simonelli, MD, PhD Chair of the Department of Pulmonary and Critical Care Medicine
- David Vawdrey, PhD Chief Data Informatics Officer
- Donna Wolk, PhD System Director of Clinical and Molecular Microbiology
To properly address and prioritize the myriad requests coming in, and to make the best use of Geisinger’s talents and resources, the Oversight Committee is divided into four work groups to consider different kinds of proposed research:
- The Clinical Trials Workgroup is cochaired by Dr. Wright and Dr. Simonelli. The first clinical trial launched after review by the workgroup is of Kevzara® (sarilumab), a pharmaceutical that’s being administered in a placebo-controlled trial to severely and critically ill hospitalized patients. The study is being conducted in partnership with Regeneron, a biopharmaceutical company that also partners with Geisinger in the MyCode® Community Health Initiative.
The Clinical Trials Workgroup is reviewing several other clinical trials, including a randomized clinical trial to study how blood serum from patients who have recovered from COVID-19 might be used to infer passive immunity to those with COVID-19 infection. The workgroup is also evaluating Geisinger’s participation in a national clinical trial involving healthcare workers, supported by a $50 million grant from the Patient Centered Outcomes Research Institute, to determine whether hydroxychloroquine might prevent them from contracting COVID-19.
- The Genomics and Viral Sequencing Studies Workgroup is cochaired by Dr. Ledbetter and Dr. Carey and makes use of data from the MyCode Community Health Initiative, an effort that’s led to the exome sequencing and genotyping of over 145,000 consenting Geisinger patients and has DNA samples currently available for the sequencing of 35,000 more.
“We launched MyCode over 10 years ago and since that time, we have amassed a lot of data,” says Dr. Ledbetter. “And when you consider the fact that we’ve had a robust electronic health record in place for decades, it’s easy to see why Geisinger is in a unique position to make some important discoveries in this area, such as whether or not there’s a genetic component that determines why one person manifests serious to lethal symptoms while another person is only mildly affected, or even asymptomatic.”
Dr. Ledbetter adds that his workgroup considers proposals not only to study human genomics; it is also considering proposals to study differences in the virus itself. “Genetic variations within the virus might explain why it affects hosts differently,” he explains.
- The Data and Observational Studies Workgroup is cochaired by Dr. Vawdrey and Mr. Leader. Their primary function is coordinating data requests, both to connect researchers to clinicians and others doing similar data studies, as well as to review external data sharing requests to ensure standard data is being used and resources are being prioritized across all data needs whether they be for clinical or research purposes.
“Geisinger has much richer, more comprehensive and better integrated data than most health systems,” Dr. Ledbetter explains. “This data will reveal a lot and should prove useful to us as well as to outside organizations.”
- The Participant Interaction and Behavioral Studies Workgroup is cochaired by Drs. Meyer and Rahm. This workgroup considers research that would involve interaction, such as surveys or interviews, with one of the system’s most important — and vulnerable — resources: COVID patients, their families, and our frontline providers. These groups have critical insights to offer about how the virus has affected them, but there is also a need to be sensitive to overwhelming them with research requests. This group also considers trials that don’t involve drugs or devices, such as behavioral or health services trials.
In addition to the work being done by the COVID-19 Research Oversight Committee Workgroups, a separate initiative is being led by Karen Murphy, PhD, RN, executive vice president and chief innovation officer of Geisinger and founding director of the Steele Institute for Health Innovation.
Dr. Murphy and her team, in partnership with the Research Population Health Sciences team, which includes chair Les Kirchner, PhD, as well as Annemarie Hirsch, PhD, Melissa Poulsen, PhD, and Dione Mercer, are performing contact tracing on people who’ve tested positive for the virus but are isolated at home because their symptoms are mild. Contact tracing involves extensive interviews to determine where people had been and who they contacted over the two weeks leading up to their quarantines. The data collected allows the team to build models that can prioritize testing for others who may have been exposed.
“Contact tracing doesn’t work once too many people are infected,” Dr. Ledbetter explains. “It’s too late for New York and New Jersey — and even for the eastern regions we serve. But if we can get the data right in central and west-central Pennsylvania, we may be able to stop the surge from happening here. I am optimistic that our various research efforts, combined with our clinical expertise, will have a significant impact when it comes to preventing and treating this pandemic — and hopefully, averting the next one.”