Clinical Research in Hepatology in the COVID-19 Pandemic and Post-Pandemic Era: Challenges and the Need for Innovation
Open Access
- 1 November 2020
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Hepatology
- Vol. 72 (5), 1819-1837
- https://doi.org/10.1002/hep.31491
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.This publication has 45 references indexed in Scilit:
- Million Veteran Program: A mega-biobank to study genetic influences on health and diseaseJournal of Clinical Epidemiology, 2016
- Web-based trial to evaluate the efficacy and safety of tolterodine ER 4mg in participants with overactive bladder: REMOTE trialContemporary Clinical Trials, 2014
- Geographic distribution of clinical trials may lead to inequities in accessClinical Investigation, 2014
- A tutorial on sensitivity analyses in clinical trials: the what, why, when and howBMC Medical Research Methodology, 2013
- Reducing Clinical Trial Monitoring Resource Allocation and Costs Through Remote Access to Electronic Medical RecordsJournal of Oncology Practice, 2013
- Missing covariate data in medical research: To impute is better than to ignoreJournal of Clinical Epidemiology, 2010
- Prolonged Therapy of Advanced Chronic Hepatitis C with Low-Dose PeginterferonThe New England Journal of Medicine, 2008
- Specific barriers to the conduct of randomized trialsClinical Trials, 2008
- A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: Results of a department of veterans affairs cooperative studyHepatology, 1993
- A Serologic Follow-up of the 1942 Epidemic of Post-Vaccination Hepatitis in the United States ArmyThe New England Journal of Medicine, 1987