Learning how to be an effective patient advocate takes a lot more than just holding up a banner, advocates learned, during an incredible live webcast run by the FDA’s Patient Network. Decoding the rules and regulatory procedure was explained in great detail—highlighting where patient’s efforts are best served to make a difference in the process. Showing how teamwork from phase one to the end of launch of a new medication is done gave patients a powerful insight into process and development, clinical trials and navigating research.
Attendees were also given a breakdown of the FDA’s regulatory process, the law and how their guidelines are woven into the production of a new treatment.
The Parent Project on Muscular Dystrophy gave an insider’s look on how one advocacy association can make a difference in the process of drug development and broke down the drug development ecosystem to explain how all factors work together to create change.
Nancy Roach of the Clinical Trials Transformation Initiative gave attendees tools to use against formidable barriers in research and how to seek success in clinical trials.
The webcast featured multiple other experts who encouraged and empowered advocates and continued their support of the patient community by leaving the webcast slides online and available to the public for viewing.
Summary: The meeting will serve as a forum for FDA’s patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. Specifically, this meeting will provide information and facilitate a discussion about: drug development and regulatory standards, clinical trial design, new regulatory tools for improving premarket drug regulation, and industry-FDA-patient collaboration for innovative drug development.