Data from trials and practice show that ambulatory patients frequently underdose, either by: never starting dosing, omitting scheduled doses, or premature cessation of dosing. Routine methods fail to detect most of these errors. Yet variable dosing histories are a major source of variance in drug response, confounding the interpretation of all dose/time-dependent trial outcomes, eg, estimates of PK parameters, dose-dependent efficacy, regimen definition, dose-dependent toxicity. Properly analyzed dosing histories can improve learning-phase trials.
FEATURED TOPICS
•Documenting and managing adherence in clinical trials
•Methods of compiling and assessing drug dosing histories
•Adherence-informed pharmacometric analysis of effectiveness
•Safety
•Dosage-regimen optimization
•Regulatory issues
•Labeling
•Statistical considerations.
FEATURED TOPICS
•Documenting and managing adherence in clinical trials
•Methods of compiling and assessing drug dosing histories
•Adherence-informed pharmacometric analysis of effectiveness
•Safety
•Dosage-regimen optimization
•Regulatory issues
•Labeling
•Statistical considerations.
