LAUSR

Background The European multicentre paediatric trials for the drug development programme of LENA (FP7 Grant agreement No. 602295); ‘Labeling of Enalapril from Neonates up to Adolescents’ require the determination of laboratory safety parameters. It was anticipated that the laboratory normal reference values and age range classifications vary depending on the clinical site. Thus, the objective was a seamless and clear depiction of the laboratory parameters to allow an adequate subsequent analysis of data. Methods Fourteen haematological and biochemical safety parameters plus the biomarker N-terminal pro-brain natriuretic peptide were considered. The laboratory normal reference values received from eight clinical sites were screened on data gaps, uncertainties, misclassifications and overlap of age range classifications. These aspects were revised. If further data were necessary for clarification the responsible person of the respective laboratory was contacted by email or telephone. Results Data gaps and uncertainties of the laboratory normal reference values such as missing data for one sex, missing data for an age range classification, missing data for a parameter or overlap of age range classification were identified. All issues were solved by communication with the sites. Each laboratory parameter was categorized in between 1 and 23 age range classifications between an age from birth to 4744 days depending on the classification of the clinical site. Furthermore, up to 4 various units were recorded per laboratory parameter and subsequently harmonised into one unit. Conclusion The developed seamless depiction of the laboratory parameters will allow the assessment and classification of the paediatric trial data and are essential for the adequate subsequent analysis. Disclosure(s) Samieh Farahani, Elisabeth Feles, Bjoern B. Burckhardt, Stephanie Laeer declare that there is no conflict of interest. The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/2007–2013) under grand agreement n°602295 (LENA)