Table 3.

The Global Perspective on Clinical Research in Hepatology^*

Domain of Clinical Research		Europe and United Kingdom	Asia	South America
Clinical trials (industry and NIH/government agencies)	Initial changes	France, Italy, Germany, and United Kingdom: similar to United States, only essential trials and shift to COVID‐19 studies, remote monitoring of study patients, variable protocol deviations	Taiwan: no changes (prepandemic state) Hong Kong: similar to United States with recruitment of new subjects not allowed, study visits of recruited studies allowed after stringent screening for symptoms, travel history, and relevant epidemiological links	Only essential trials Hold on startup of new nonessential trials COVID‐19 research mostly limited to observational studies
	Re‐entry and long‐term strategy	Gradual re‐entry as in the United States Slower enrollment Remote study initiation and monitoring when possible (Germany); need for improved remote study procedures (France) Very slow recovery in countries and regions of high prevalence (Italy, Spain)	Taiwan: not applicable (prepandemic state) Hong Kong: similar to United States with the exception of remote study procedures, which are generally not allowed	Variable re‐entry strategies among South American countries Phone and telemedicine follow‐up If pandemic prolongs, South America will be an attractive option for new clinical trials.
Real‐world data	Initial changes	France, Germany, Italy, and United Kingdom: decline in patient encounters, remote data entry and data transfers ongoing, shift to COVID‐19 studies New studies on hold in France and Italy; slower to initiate in Germany	Taiwan: decline in patient encounters and decreased data generation during this period Hong Kong: similar to United States	Ongoing datasets have continued, albeit with reduced inclusion rate. Shift to COVID‐19 registries
	Re‐entry and long‐term strategy	As in United States, ongoing transition to remote procedures in France, United Kingdom, Germany; positive engagement in data bases in the United Kingdom Limited room for remote procedures in Italy In Germany, Italy, and France, as per United States, maintaining research infrastructure In Germany and France, as per United States, need for diversification of IT approach Shift to COVID‐19 studies in France, Germany, Italy, and the United Kingdom	Taiwan: no changes (prepandemic state) Hong Kong: research team activities by online platform	Difficult to assess; huge economic crisis in the region Many training fellowship programs closed this year; thus, increased staff clinical duties Research funding resources transferred to cover salaries
Biorepository, natural history, and biomarker studies	Initial changes	France, Germany, Italy, and United Kingdom: largely on hold in except HCC studies in France and advanced liver disease in Germany Similar to United States in shift to remote ascertainment of clinical events and in concerns with specimen collection (France, Germany, Italy)	Taiwan: no changes (prepandemic state) Hong Kong: shift to remote ascertainment of clinical events	This area is far less developed than in other regions. Virology laboratory shift to COVID‐19 testing, limiting other activities
	Re‐entry and long‐term strategy	France, Germany, Italy, and United Kingdom: variable priority of re‐entry phases Meeting enrollment goals will be a challenge. France and Germany: similar to United States in impact of patient perspective and decreased clinic visits; in Italy, small impact of patient perspective or decrease in clinic visits Similar to United States, develop innovative remote monitoring and assessment strategies (France and Germany); none planned in Italy or United Kingdom	Taiwan: no changes (prepandemic state) Hong Kong: specimen collection impacted by patient perspective and decreased clinical visits	Still struggling because of COVID‐19 pandemic; no real strategy at the moment

^*Based on valuable contributions from professors Stefan Zeuzem and Jonel Trebicka (Germany), Graham Foster (United Kingdom), Pietro Lampertico (Italy), Fabien Zoulim (France), Grace Wong (Hong Kong), Jia‐Horng Kao (Taiwan), and Dr. Manuel Mendizabal (Argentina).

Abbreviations: IT, information technology; HCC, hepatocellular carcinoma.