JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 489
Type: Invited
Date/Time: Thursday, August 2, 2007 : 8:30 AM to 10:20 AM
Sponsor: ENAR
Abstract - #307973
Title: Noncompliance with Drug-Dosing Regimens: An Underestimated Bias in Drug Trials and Clinical Practice
Author(s): Bernard Vrijens*+
Companies: Pharmionic Systems Ltd.
Address: Rue des Cyclistes Frontière 24, Visé, BE-4600, Belgium
Keywords: Adherence ; Compliance ; Persistence ; Electronic Monitoring
Abstract:

The Pharmionic Knowledge Centre is a data warehouse on more than 20000 ambulatory patients whose dosing histories during studies of varying lengths have been electronically compiled. Electronic Medication Event Monitors were used to record the times and dates of drug dosing during the course of >90 drug trials between 1990 and 2006. Chapter headings in the British National Formulary served to categorize fields of treatment. Study durations ranged from 30 to 1400 days. Patterns of deviation from prescribed dosing regimens varied widely, but were almost entirely markedly skewed toward longer dosing intervals than prescribed, i.e. under-dosing, in every field of treatment. Drug holidays, and early cessation of dosing are common features in ambulatory patients, and likely are frequent sources of low response and high variability in response to the prescribed dosing regimen.


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Revised September, 2007