The Informed Consent Action Network (ICAN) is dedicated to ensuring its members and the public are informed about consumer safety issues.
On April 29, 2020, you stated that “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery” for COVID-19 patients and that remdesivir “will be the standard of care” for this infection.
This study appears to have many serious irregularities as detailed below. Prior to sending these concerns to the appropriate federal ethics and oversight committees, we wanted to provide you an opportunity to respond.
The study at issue, a multi-center randomized clinical trial, commenced on February 21, 2020. Like all such studies, before it commenced a detailed study protocol was established. It is critical that the protocol be set in stone before a study begins. This assures the validity of the study.
Despite the importance of adhering the study protocol, there were numerous substantive deviations in the NIAID’s study of remdesivir....