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COA Discussion Forum with the ERIQA Group
The Food and Drug Administration (FDA) announced a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. This workshop was held on October 19, 2011, at the FDA.
Considering the importance of the topic to the field of clinical development of new drugs, the MAPI Research Trust has decided to reactivate the European Regulatory Issues and Quality of Life Assessment (ERIQA) Group to comment on the key topics presented during this workshop. The ERIQA group had been created in 1997 to bring together representatives from the pharmaceutical industry, academia and the health authorities to identify ways to integrate quality of life assessment into the regulatory process and was instrumental in paving the way for the publication of the FDA’s PRO draft guidance in 2006.
Several topics, in particular the 5 topics presented uring the FDA workshop, will be discussed during the online forum which will be moderated by Catherine Acquadro.
A summary of the discussions held during the workshop on 19 October will be prepared by Catherine Acquadro (Mapi Research Trust) and Antoine Regnault (Mapi Values) and posted on the forum.
To make this lively and interactive we would like to invite you to post and share your comments, suggestions and reactions to the workshop.
To enter the forum, please click on COA Dicussion Forum with the ERIQA Group.
We look forward to meeting with you online soon.
Bernard Jambon, CEO MAPI Group
http://www.eriqa-project.com
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Last post by C. Acquadro
Sat Nov 05, 2011 11:23 am
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