Workshop Description
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.

Who Should Attend?
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.

What to Expect?
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.

Aren't available to attend in person? 
This public workshop will also be available as a Webcast for registrants only.  Persons interested in viewing the Webcast must register online at the TRIBES Website by November 19, 2012.  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.