Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says
Quarantines, travel restrictions and supply chain interruptions are likely to cause 'unavoidable protocol deviations' in ongoing clinical trials, FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by the coronavirus.
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Routine inclusion of approaches such as local assessments and remote monitoring could reduce patient burden and avoid protocol deviations, but industry needs to see a return on investment, in the form of easier recruitment, better diversity and/or faster studies, experts said.
Draft guidance notes that data obtained from a decentralized clinical trial may be less precise than that from a site-based trial, creating challenges in calculating a non-inferiority margin. FDA specifies what should be included in DCT data management, trial monitoring and safety monitoring plans.
While pharma is keen to condemn Russia’s aggression, suspension of trials is driven by logistical considerations; US FDA said it stands ready to assist sponsors of disrupted trials in Russia and Ukraine to help ensure the safety of trial participants and integrity of the studies.