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. Read More
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. Read More
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. Read More
Sponsors of drug trials should publish clinical trial reports without redacting confidential information, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) said in a statement last week. Read More
Informed consent forms used for COVID-19 vaccine clinical trials were unnecessarily long, difficult to read and required recipients to have at least a ninth-grade reading level — compared to a norm of sixth-grade — to fully comprehend, according to a new study. Read More
The FDA said last week that it plans to gradually resume on-site clinical trial inspections beginning in July with the intent to be back to normal operations by September. Read More
To learn more about the quality of data collected remotely during the pandemic, the FDA is asking oncology drug trials to voluntarily flag data collected remotely rather than onsite. Read More
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