Enhancing the Quality of Laboratory Results in Clinical Trials

Author(s): Menon PK, Rahul S, Nidhi S, Thanzeel M.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 1 , Issue 1 , 2014

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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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Article Details

Year: 2014
Page: [37 - 42]
Pages: 6
DOI: 10.2174/2213476X01666140324183008

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