Zdrowie i gospodarka · 11/7/2012
Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation." FDA is co-sponsoring this public workshop together with the Board of Regents of the University System of Georgia by and on behalf of the Georgia Institute of Technology's Translational Research Institute for Biomedical Engineering and Science (TRIBES). The purpose of this public workshop is to bring together a wide variety of stakeholders to discuss key topics relating to minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related procedures in order to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design. Date and Time: The public workshop will be held on November 27, 2012, from 7:45 a.m. to 5:30 p.m., and on November 28, 2012, from 7:45 a.m. to 1 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993, on November 27, 201