COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union.

ABSTRACT: The coronavirus disease 2019 (COVID-19) pandemic and the accompanying control measures have significantly affected clinical trial (CT) conduct, and sponsors have needed to make rapid changes to their CT operations. As a result, regulatory guidance was pivotal during the initial phases of the pandemic. This study aimed to evaluate the regulatory readiness and guidance related to COVID-19 in the European Union (EU). The European Medicines Agency (EMA) and national competent authorities' (NCAs') websites were searched in September and October 2020 for guidances on the management of CTs during the pandemic published from January 2020 onward. "Regulatory readiness" was defined as the number of days from the first European COVID-19 case (January 24, 2020) to the first published guidance by the r

SUBMITTER: de Jong AJ 

PROVIDER: S-EPMC8013428 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature