Minimum Clinically Important Difference (MCID): Defining Outcome Metrics for Othopaedic Devices

Event Details
Contact

Martha Willis

Summaries

Summary Sentence: 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 device

Full Summary: 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.

November 27-28, 2012

The Translational Research Institute for Biomedical Engineering and Science (TRIBES) presents:

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.

Related Links

Additional Information

In Campus Calendar
Yes
Groups

IBB Center - TRIBES

Invited Audience
No audiences were selected.
Categories
Conference/Symposium
Keywords
Minimum Clinically Important Difference (MCID) Conference
Status
  • Created By: Jenilee Shanks
  • Workflow Status: Published
  • Created On: Oct 10, 2012 - 6:07am
  • Last Updated: Oct 7, 2016 - 10:00pm