Here is some very big news. The FDA has just launched a patient network website (see: The FDA Patient Network Website - Pretty Darn Patient-Centered). Here are the details:
The twin goals for this website are promoting the educational mission of the FDA, and promoting opportunities for patient advocacy within the FDA — and earlier in the policymaking process than has been the case historically....[A spokesperson described it in the following way:]“The idea is to engage the patient community, to have the patient voice heard at the FDA....The FDA Safety & Innovation Act (enacted in mid-2012) mandates the involvement of patient representatives in roles beyond those of the advisory committees. Draft procedures for patient involvement are due to be made public in September of this year....Unlike opportunities for patient involvement in other government agencies, the FDA recognizes patient representatives on advisory committees (and in the new roles) as consultants....and this means that patients involved in the FDA processes in an official capacity are paid for their time and expenses. Aside from this new program, the website really just puts a patient-friendly face on an existing set of resources — clinical trials, investigational products, and more — but the improvement is quite welcome.
Long overdue is the feature of the FDA site that provides a much clearer advice for patients regarding participation in clinical trials. Previously, most of this was in the hands of treating physicians. As I was browsing the various links in the clinical trials section of the FDA patient network website, I came across the following information regarding what a patient should think about before joining a clinical trial:
Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:
- what happens during the trial
- the type of health care you will receive
- any related costs once you are enrolled in the trial
- the benefits and risks associated with participating.
Very succinct advice and also very important and relevant. As a former member of an IRB, I can attest to the fact that each of these bulleted points is critical and worthy of extensive conversation before joining a clinical trail. I encourage all patients with serious disease to utilize the FDA patient web site and not remain totally depend on their physicians' advice for consideration and admission to clinical trials. I am also impressed by the fact that the FDA has developed this web site in what seems to be a patient-friendly way and tried to avoid too much bureaucratic and regulatory jargon.