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Abstract Details
Clinical Research in Hepatology in the COVID-19 Pandemic and Post-Pandemic Era: Challenges and the Need for Innovation
Hepatology. 2020 Aug 2. doi: 10.1002/hep.31491. Online ahead of print.
Elizabeth C Verna1, Marina Serper2, Jaime Chu3, Kathleen Corey4, Oren K Fix5, Karen Hoyt6, Kimberly A Page7, Rohit Loomba8, Ming Li9, Gregory T Everson10, Michael W Fried11, Guadalupe Garcia-Tsao12, Norah Terrault9, Anna S Lok13, Raymond T Chung4, K Rajender Reddy2
Author information
1Center for Liver Disease and Transplantation, Columbia University Irving Medical Center, New York, NY, United States.
2University of Pennsylvania, Philadelphia, PA, United States.
3Mt. Sinai School of Medicine, New York, NY, United States.
4Liver Center, Massachusetts General Hospital, Boston, MA, United States.
5Swedish Medical Center, Seattle, WA, United States.
6Southern Nazarene University, Bethel, OK, United States.
7University of New Mexico School of Medicine, Albuquerque, NM, United States.
8UC San Diego School of Medicine, San Diego, CA, United States.
9Keck School of Medicine of USC, Los Angeles, CA, United States.
10University of Colorado Denver School of Medicine, and HepQuant LLC, Aurora, CO, Greenwood Village, CO, United States.
11University of North Carolina School of Medicine, Chapel Hill, NC, United States.
12Yale School of Medicine, New Haven, CT, United States.
13University of Michigan Medical School, Ann Arbor, MI, United States.
Abstract
The SARS-CoV-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. NIH, foundation and industry funding has provided important opportunities to advance the academic careers of young investigators while they strived to make contributions to the field. Instantaneously, however, all non-essential research activities were halted when the pandemic started, forcing those involved in clinical research to re-think their research strategy, including a shift to COVID-19 research while endeavoring to maintain their pre-existing agenda. Strategies to maintain the integrity of ongoing studies, including patient follow up, safety assessments and continuation of investigation products, have included a shift to telemedicine, remote safety laboratory monitoring, and shipping of investigational products to study subjects. As a re-vamp of research is being planned, unique issues that face the research community include maintenance of infrastructure, funding, completion of studies in the pre-determined time frame and the need to re-program 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.