Enhancing the Quality of Laboratory Results in Clinical Trials
Diagnostic tests remain the cornerstone of diagnosis and treatment in patient management. The diagnostic testing
cycle is described as the Brain to Brain cycle. Five Phases of diagnostic testing have been conventionally defined
which intervene between the Brain to Brain phases of a diagnostic test. They are the Pre-Pre Analytic phase, Pre Analytic
phase, Analytic phase, Post-Analytic phase and the Post-Post Analytic phase. In clinical trials, where central lab testing is
carried out, tight controls on these variables help enhance the reliability of test results and reduce dropouts. This article
explores the scope and role of the various phases in determining Clinical Trial outcomes. In Clinical Trials, laboratory
testing plays an important role not only in safety testing but also in determining the therapeutic efficacy of the intervention.
This paper discusses the variables associated with laboratory testing in Clinical Trials and explore strategies to
enhance its accuracy.
Keywords: Analytic phases, pre-pre analytic phase, pre-analytic phase, analytic phase, post-analytic phase, post-post analytic
phase, clinical trial, calibration, quality assurance, quality control.
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