This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 61
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307091
Title: Issues of Missing Data in Orthopedic Implant Clinical Trials: A Regulatory Reviewer's Perspective
Author(s): Jianxiong Chu*+
Companies: FDA
Address: 10903 New Hampshire Ave, Silver Spring, MD, 20993,
Keywords: missing data ; LOCF ; orthopedic implant

Missing data is inevitable in most device trials despite carefully designed and executed investigational plans. In this talk, I would discuss the common missing patterns in terms of missing percentage, timing and reasons for missingness as observed from orthopedic implant trials. Potential impacts on the missing patterns from the open-label nature and the involvement of the surgeon to re-fix the implant will be emphasized. Current common practices for handling missing data will also be discussed followed by a proposal that, in contrast to a single method treating all missing data uniformly regardless of the different missing patterns, missing data could be classified into several categories of most plausible missing mechanisms and handled with a hybrid approach, i.e., apply several approaches (sensible LOCF, multiple imputation, etc.) to the different subsets of missing data.

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Authors who are presenting talks have a * after their name.

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