Regulatory authorities issued recommendations on how to manage the effects of COVID-19-related societal disruptions on clinical trial conduct soon after the pandemic started. This was to ensure the safety of trial participants and secure trial integrity and data validity. But when it comes to the reporting of such studies, the authority guidance is sparse.
With many clinical trials conducted during the pandemic now entering the reporting phase, we realize that clinical researchers will be seeking guidance for how to adequately report the impact of the COVID-19 pandemic in the clinical study report (CSR). Thus, we set out to summarize some of the overarching principles and important considerations to help sponsors when writing a CSR for a trial impacted by COVID-19.
Based on our experience, common issues and causes of uncertainties include situations where:
- Participants could not come to the sites for their visits
- Planned assessments were not performed leading to missing data
- Participants did not get the trial drug
- Participants or trial staff fell ill with COVID-19
But what level of detail do the regulatory authorities expect in the CSR? Where in the report should the information be placed? And which topics are most important to focus on?
THIS article from Larix explores these important areas and provide best practices for a sequential and efficient approach.
The article has been published with Cmed, who joined forces with Larix and Encapsia as part of the Aixial group.