Clinical Research in Hepatology in the COVID‐19 Pandemic and Post‐Pandemic Era: Challenges and the Need for Innovation
Year: 2020
Type: article
Abstract: The severe acute respiratory syndrome coronavirus 2 pandemic has drastically altered all facets of clinical care and research. Clinical research in hepatology has had a rich tradition in several domains, including the discovery and therapeutic development for diseases such as hepatitis B and C and studying the natural history of many forms of chronic liver disease. National Institutes of Health, foundation, and industry funding have provided important opportunities to advance the academic careers of young investigators while they strived to make contributions to the field. Instantaneously, however, all nonessential research activities were halted when the pandemic started, forcing those involved in clinical research to rethink their research strategy, including a shift to coronavirus disease 2019 research while endeavoring to maintain their preexisting agenda. Strategies to maintain the integrity of ongoing studies, including patient follow-up, safety assessments, and continuation of investigational products, have included a shift to telemedicine, remote safety laboratory monitoring, and shipping of investigational products to study subjects. As a revamp of research is being planned, unique issues that face the research community include maintenance of infrastructure, funding, completion of studies in the predetermined time frame, and the need to reprogram career path timelines. Real-world databases, biomarker and long-term follow up studies, and research involving special groups (children, the homeless, and other marginalized populations) are likely to face unique challenges. The implementation of telemedicine has been dramatically accelerated and will serve as a backbone for the future of clinical research. As we move forward, innovation in clinical trial design will be essential for conducting optimized clinical research.
Source: Hepatology
DOI: 10.1002/hep.31491
Authors: Elizabeth C. Verna, Marina Serper, Jaime Chu, Kathleen Corey, Oren K. Fix, Karen Hoyt, Kimberly A. Page, Rohit Loomba, Ming Li, Gregory T. Everson, Michael W. Fried, Guadalupe Garcia‐Tsao, Norah Terrault, Anna S. Lok, Raymond T. Chung, K. Rajender Reddy
Institutions: Columbia University Irving Medical Center, University of Pennsylvania, Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, Swedish Medical Center, Southern Nazarene University, University of New Mexico, UC San Diego Health System, University of California San Diego, University of Southern California, HepQuant (United States), University of Colorado Anschutz, University of Colorado Denver, University of North Carolina at Chapel Hill, University of North Carolina Health Care, Columbia University, Yale University, University of Michigan, Michigan Medicine
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: U.S. Department of Defense, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Massachusetts General Hospital, Yale University, American Association for the Study of Liver Diseases, Gilead Sciences, Alnylam Pharmaceuticals, Celgene, Northwestern University, Henry Ford Health System, Rush University, Regeneron Pharmaceuticals, Arrowhead Pharmaceuticals, NGM Biopharmaceuticals, Novo Nordisk, Grifols, National Institutes of Health, Genentech, Uniformed Services University of the Health Sciences, Allergan, University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences, National Center for Advancing Translational Sciences, DOD Peer Reviewed Cancer Research Program
OpenAlex ID: W3046900637