October 05, 2012 -- Register at: http://www.tribes.gatech.edu/mcid-conf-2012
Registration is now open for the 2012 Minimum Clinically Important Difference (MCID) Conference. Co-sponsored by the Food and Drug Administration (FDA) and Georgia Institute of Technology’s Translational Research Institute for Biomedical Engineering and Science (TRIBES), the conference will focus on defining outcome metrics for othopaedic devices. This workshop will bring FDA internal experts together with academic and industry stakeholders to discuss challenges and approaches in defining minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic device-related procedures. The goal is to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design for gender, age and BMI factors.
The workshop will be held November 27 and 28, 2012 at the U.S. Food and Drug Administration’s White Oak Campus in Silver Spring, MD.
This one and a half day meeting will include presentations by the FDA, industry participants, and academia on day one. Breakout sessions on day two will develop and present feedback in specific clinical areas from experts in the field concerning the appropriate methodology and strategy to launch future work and guidance.
When: Tuesday, November 27, 2012 7:00 am - 5:30 pm Building 31 (Great Room) Wednesday, November 28, 2012 7:45 am - 1:00 pm Building 66 (Atrium)
Where: U.S. Food and Drug Administration White Oak Campus 10903 New Hampshire Avenue, Silver Spring, Maryland 20993
Please contact Martha Willis at martha.willis@gatech.edu with questions or go to http://www.tribes.gatech.edu/mcid-conf-2012 for more information.
