To: Dr. Margaret A. Hamburg, Commissioner, Food and Drug Administration, The United States House of Representatives, and The United States Senate

FDA: Require a Patient Advocate in Clinical Trial

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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.

Why is this important?

Clinical trial of investigational new drugs are an essential part of the process through which vitally needed new medicines reach the market. While rules assuring patient safety are in place through the Food and Drug Administration, the Office of Human Research Protections and participating Clinical Trial institutions, compliance varies.

An Independent Patient Advocate would provide a needed communications conduit and meaningful oversight of Patient safety.

Despite an FDA Guidance for Clinical Trial Sponsors that recommends inclusion of patients in Data Monitoring Committees, there is no required Patient involvement or oversight in monitoring the conduct of a clinical trial. There is no conduit for Patients to express concerns over care beyond their attending healthcare professionals. Patients are routinely excluded from knowledge of their own clinical trials, including knowledge of unanticipated adverse events.

As Patients in clinical trial, we need to know that our health concerns will be heard and that all SAEs will be reported to us promptly and the risk assessment conveyed to us as quickly as possible, Only when we are fully informed can we provide meaningful informed consent to participate in the Clinical Trial protocol.