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

Abstract Details

Activity Number: 391
Type: Topic Contributed
Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307486
Title: Missing Data in Clinical Trials
Author(s): Herbert Thijs*+
Companies: I-Biostat
Address: Agoralaan 1, Diepenbeek, 3590, Belgium
Keywords: clinical trials ; pain ; tolerability and efficacy ; missing data ; direct likelihood ; NOCF
Abstract:

In clinical trials related to pain incomplete data is a common issue. Methods to analyze data subject to incompleteness are CC, LOCF, BOCF... While some of them are used for a long time, others were more recently developed in order to cope with increasing criticism. Given the relation to pain treatment the defense of above mentioned methods exists in the fact that tolerability of pain drugs often is an issue which needs to be taken into account and authorities claim that patients who cannot tolerate the drug should be treated as non-responders.

However, statistically it can be shown easily that carried forward methods, violate the information in the data tremendously and lead to biased results which can be both conservative and liberal. In this manuscript therefore we state NO Carrying Forward (NOCF) as the strategy to deal with missing data and propose a direct likelihood approach.


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