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There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, and that has now been detected in many locations internationally. COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing. Due to the Coronavirus situation most of European Regulatory Authority (Italy, Spain, UK, Finland, Denmark, etc.) and FDA provided some advice regarding the clinical trials during the pandemic. In this article I want to provide a summary of advises provided by the Regulatory Authority. These measures are intended to preserve the activities of the trial as far as possible, guaranteeing the health care of the patients, protecting their safety and well-being and preserving the traceability of the actions implemented in this health emergency situation. It is expected that the sponsor performs a thorough risk assessment of each individual ongoing trial and implements measures which priorities patient safety and data validity. In case these two conflicts, patient safety should take priority. These risk assessments should be based on relevant parties’ input and should be documented on an ongoing basis. The Sponsor should reassess risk as the situation develops. This reassessment should also be documented.
Published Date: 2020-04-14; Received Date: 2020-03-25