Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic
Elena S. Izmailova, Robert Ellis, Christopher Benko
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has rapidly challenged the pharmaceutical industry to implement remote clinical trials. The industry's lack of extensive experience with remote measurements initiates multiple questions about how to select candidates for remote collection, their validity, and regulatory implications of moving certain assessments to a remote mode. We propose a decision tree for migration of clinic to remote assessments and highlight activities required to ensure that these measurements are valid, safe, and usable.
Topics & Concepts
PandemicCoronavirus disease 2019 (COVID-19)USableSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)2019-20 coronavirus outbreakClinical trialData collectionMedicineRemote sensingComputer scienceData scienceDiseaseGeographyOutbreakVirologyPathologyInfectious disease (medical specialty)World Wide WebStatisticsMathematicsBiosimilars and Bioanalytical MethodsStatistical Methods in Clinical TrialsInnovative Microfluidic and Catalytic Techniques Innovation