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.
© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.
MeSH terms
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Betacoronavirus / pathogenicity
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COVID-19
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Clinical Trials as Topic / methods*
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Clinical Trials as Topic / standards
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Coronavirus Infections / epidemiology
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Coronavirus Infections / prevention & control*
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Coronavirus Infections / transmission
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Coronavirus Infections / virology
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Data Collection / instrumentation
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Data Collection / methods
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Humans
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Infection Control / standards*
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Monitoring, Physiologic / instrumentation
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Monitoring, Physiologic / methods*
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Monitoring, Physiologic / trends
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Pandemics / prevention & control*
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Patient Participation
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Patient Selection
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Pneumonia, Viral / epidemiology
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Pneumonia, Viral / prevention & control*
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Pneumonia, Viral / transmission
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Pneumonia, Viral / virology
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Remote Sensing Technology
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Research Design*
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SARS-CoV-2
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Telemedicine / instrumentation
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Telemedicine / methods
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Telemedicine / trends