Back in 2012 when the FDASIA reauthorized the Prescription Drug User Fee Act (PDUFA), The FDA pioneered the use of patient focused drug development meetings to help address the need for systematic collection of direct patient input. To date they have held twenty-two meetings each focused on a different disease area and have identified key findings including that patients living with a disease are experts on what it is like to live with the condition. In addition, the meeting highlighted that what patients care most about may not always be factored into clinical trials or approved labeling. Why?
Most of the burden of disease data was based not on patient input but rather on symptoms which in turn were used to define endpoints of the study or trial. NONE of this was truly based LIVING with the disease. Those endpoints were determined strictly in the lab and were really nothing more than the starting hypothesis. Or in the other word a symptom
All of us patients know that living with a disease is entirely a different matter. Occasionally there is a company who gets it or at least wants to get it and opportunities for rare disease patients to give primary research direct input are very infrequent. Couch Health is offering *our VWD patients one of those opportunities.
COUCH Health is organizing a survey to gain an understanding of the lived experiences of VWD. The survey will cover topics such as diagnosis journey, healthcare experiences and clinical trials. The insights gained will serve to improve healthcare services and help plan for more patient centric services in the future. We encourage all of our VWD community to participate in opportunities to give first person accounts directly to research and **
pharma of the lived experiences of VWD. Your input matters!
COUCH Health will ensure that the data collected remains protected and confidential.
Here’s the link to the study: https://parexelcore.iad1.qualtrics.com/jfe/form/SV_79eqOy1k5aYvdlQ