John Walsh, President of the COPD Foun- dation, is asking all people with COPD to become involved with the Patient-Centered Outcomes Research Institute – PCORI. The nonprofit agency is funded by imposed fees on health insurance policies. PCORI’s purpose is to assist people involved in health care – the patients, medical personnel, pur- chasers and policy makers – to make better decisions. The information learned from en- rolled people will help to prevent, diagnose, treat, monitor and manage disease. Anyone over the age of 18 with a confirmed diagno- sis of COPD is eligible to enroll.
The COPD Patient-Powered Research Network will be part of other registry networks and together will be called the National Patient Centered Clinical Research Network. To join, call the COPD Founda- tion at 1-866-316-2673 or go to www.copd foundation.org and click on the ‘Research’ tab. The registry form will ask about your symptoms, breathlessness, smoking history and other medical problems. They are hop- ing to enroll 75,000 individuals.
The COPD Foundation has also launched an interactive social network on their web site so you could interact with others. Visit the main web page at www.copdfoundation. org and click on the ‘360social’ tab to learn
Your Voices Count!
The FDA published a Federal Register notice announcing the establishment of a public docket for comments on FDA activ- ities performed under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. They would like to have a more systematic approach to includ- ing a patient consultant voice earlier in the product development process.
There are various ways that a patient or caregiver may participate. One program that FDA has managed for many years is the patient representative program, where patients or their caregivers participate as members of FDA’s therapeutic advisory committees to review important questions about safety and efficacy of products un- der consideration for marketing approval with other members of various FDA expert advisory committees.
For more information email Andrea Furia-Helms at [email protected] or write to her at:
Food and Drug Administration 10903 New Hampshire Ave.
Building 32, Room 5319
Silver Spring, MD 20993-0002