Sponsors should look to their own risk assessment models to determine if trial data that was monitored remotely should be re-examined once the pandemic eases and on-site monitoring visits resume, the FDA says in the latest revision of its guidance on conducting clinical trials during the COVID-19 pandemic.
The American Society of Clinical Oncology and Friends of Cancer Research have called on sponsors to begin including cancer patients in their COVID-19 vaccine trials unless there’s a potential safety risk.
The number of vaccine and therapeutic clinical trials targeting COVID-19 have been trending in opposite directions for months, a new analysis shows, with the number of vaccine trials increasing steadily and therapeutic trials on the decline.