Subject: FDA: Require a Patient Advocate in Clinical Trial
The Zebra Coalition created a petition to Dr. Margaret A. Hamburg, Commissioner, Food and Drug Administration, The United States House of Representatives, and The United States Senate which says:
“We ask that the FDA require a Patient Advocate be available at every Investigative New Drug clinical trial site to provide a needed level of Patient safety. The Patient Advocate would be informed — along with site Investigators — of every Severe Adverse Event (SAE) occurring in the course of the trial.
The Patient Advocate would be empowered to communicate directly with Patients and with Investigators on behalf of Patients. ”
Will you sign this petition? Click here: