From Local Laboratory to Standardisation and beyond - Applying a common grading system


Data Management of Laboratory Data, such as haematology and biochemistry, can be very time consuming, especially when data are collected in different local laboratories, all of them with different normal ranges and units. This is the standard situation in oncology, where patients usually have their blood samples drawn outside the hospital, after being discharged or when therapy is administered at home. The present paper will review the full process of dealing with such data, and the application of a common grading system, the CTCAE grading system, will be also described. INTRODUCTION Most clinical trials collect laboratory data. The procedures for biological samples processing and the amount of laboratory data collected can be very different depending on the type of trial. Laboratory tests performed within clinical trials in oncology are used both to make immediate clinical decisions for patient’s care and to define the drug profile according to the trial objectives. Early oncology clinical trials, which are often performed in a population with advanced disease in centres of excellence serving a broad geographical area and testing toxic compounds, require frequent samplings, and laboratory results must be available to the treating physician in a very short time for quick decision making; as a consequence, the use of multiple local laboratories cannot be avoided mainly for patients convenience. The results are thus obtained using different equipments and assays which make reference to different ranges of normality and are expressed in different units. This heterogeneity implies great efforts to collect a series of different normal ranges and the need for some methods of conversion to ensure comparability of results. The aim of this paper is to discuss different methods of data homogenization, trying to identify the most efficient ones in the context of early oncology studies. LABORATORY TESTS FOR DRUG SAFETY MONITORING Laboratory tests in clinical trials can be used for safety, activity, pharmacodynamic, pharmacokinetic, pharmacogenomic assessments but for the purpose of this paper we will focus on hematology and blood biochemistry parameters for which the use of central laboratories is usually not feasible. PARAMETERS COMMONLY USED IN CLINICAL TRIALS Laboratory results can be expressed with a quantitative numeric or semi-quantitative value (i.e. trace) or qualitative value (i.e. +/-). For most hematology and biochemistry tests, the results are expressed with quantitative numeric values. Common parameters measured for hematology are: Hematocrit; Hemoglobin; Platelets; Red Blood Cells (RBC); White Blood Cells (WBC) with differential count for Neutrophils, Lymphocytes, Monocytes, Basophils and Eosinophils For the chemistry, the most common collected parameters are the following: Electrolytes Sodium; Potassium; Magnesium;

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@inproceedings{Tinazzi2007FromLL, title={From Local Laboratory to Standardisation and beyond - Applying a common grading system}, author={Angelo Tinazzi and Irene Corradino and Enrica Paschetto and Sonia Colombini}, year={2007} }