{"160971":{"#nid":"160971","#data":{"type":"event","title":"Minimum Clinically Important Difference (MCID): Defining Outcome Metrics for Othopaedic Devices","body":[{"value":"\u003Cp\u003ENovember 27-28, 2012\u003Cbr \/\u003E\u003Cbr \/\u003EThe Translational Research Institute for Biomedical Engineering and Science (TRIBES) presents:\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EWorkshop Description\u003C\/strong\u003E\u003Cbr \/\u003E 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.\u003Cbr \/\u003E \u003Cbr \/\u003E \u003Cstrong\u003EWho Should Attend?\u003C\/strong\u003E\u003Cbr \/\u003E Orthopaedic device companies focusing on upper and lower extremities, regulatory affairs, clinical evaluators, product developers, project managers, contract research organizations and academic researchers and industry stakeholders responsible for designing, implementing, analyzing and reviewing MCID for orthopaedic device clinical studies. FDA participants expected to participate come from the following areas: CDRH, ODE, OJDB, OSB, OWH, and AHRQ.\u003Cbr \/\u003E \u003Cbr \/\u003E \u003Cstrong\u003EWhat to Expect?\u003C\/strong\u003E\u003Cbr \/\u003E 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.\u003Cbr \/\u003E\u003Cbr \/\u003E\u003Cstrong\u003E\u003Cem\u003EAren\u0027t available to attend in person?\u003C\/em\u003E\u0026nbsp; \u003C\/strong\u003E\u003Cbr \/\u003EThis public workshop will also be available as a Webcast for registrants only.\u0026nbsp; Persons interested in viewing the Webcast must register online at the \u003Ca href=\u0022http:\/\/www.regonline.com\/builder\/site\/Default.aspx?EventID=1149565\u0022\u003ETRIBES Website\u003C\/a\u003E by \u003Cstrong\u003ENovember 19, 2012\u003C\/strong\u003E.\u0026nbsp; Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 19, 2012.\u003Cbr \/\u003E\u003Cbr \/\u003E\u003C\/p\u003E","summary":null,"format":"limited_html"}],"field_subtitle":"","field_summary":[{"value":"\u003Cp\u003ECo-sponsored by the Food and Drug Administration (FDA) and Georgia Institute of Technology\u2019s Translational Research Institute for Biomedical Engineering and Science (TRIBES), the conference will focus on defining outcome metrics for othopaedic devices.\u003C\/p\u003E","format":"limited_html"}],"field_summary_sentence":[{"value":"Co-sponsored by the Food and Drug Administration (FDA) and Georgia Institute of Technology\u2019s Translational Research Institute for Biomedical Engineering and Science (TRIBES), the conference will focus on defining outcome metrics for othopaedic device"}],"uid":"27722","created_gmt":"2012-10-10 10:07:43","changed_gmt":"2016-10-08 02:00:16","author":"Jenilee Shanks","boilerplate_text":"","field_publication":"","field_article_url":"","field_event_time":{"event_time_start":"2012-11-27T07:00:00-05:00","event_time_end":"2012-11-28T16:30:00-05:00","event_time_end_last":"2012-11-28T16:30:00-05:00","gmt_time_start":"2012-11-27 12:00:00","gmt_time_end":"2012-11-28 21:30:00","gmt_time_end_last":"2012-11-28 21:30:00","rrule":"RRULE:FREQ=DAILY;INTERVAL=1;UNTIL=20121129T045959Z;WKST=SU","timezone":"America\/New_York"},"extras":[],"related_links":[{"url":"http:\/\/gatech.us4.list-manage.com\/track\/click?e=c3b3305935\u0026id=4422ade649\u0026u=6ec9804eefa1d92360554aac1","title":"Conference website"},{"url":"http:\/\/www.fda.gov\/MedicalDevices\/NewsEvents\/WorkshopsConferences\/ucm327292.htm","title":"FDA conference website"}],"groups":[{"id":"67773","name":"IBB Center - TRIBES"}],"categories":[],"keywords":[{"id":"50321","name":"Minimum Clinically Important Difference (MCID) Conference"}],"core_research_areas":[],"news_room_topics":[],"event_categories":[{"id":"1789","name":"Conference\/Symposium"}],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cp\u003E\u003Ca href=\u0022mailto:martha.willis@gatech.edu\u0022\u003EMartha Willis\u003C\/a\u003E\u003C\/p\u003E","format":"limited_html"}],"email":[],"slides":[],"orientation":[],"userdata":""}}}