Sites and sponsors should conduct certain analyses with their trial data during COVID-19 to determine empirically whether their data-capture methods remain valid because of the impact the pandemic is having on how patients are reporting outcomes. Proper surveillance can alert sponsors and sites to when interventions are needed to remediate inconsistencies in symptom reporting, while statistical analysis can be used to judge whether certain types of data can be integrated with the rest of a dataset, says Nathaniel Katz, chief science officer at WCG Analgesic Solutions.
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