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Standardizing in vitro diagnostics tasks in clinical trials: a call for action

Giuseppe Lippi1, Ana-Maria Simundic1, Leocadio Rodriguez-Manas1

  • 11 Working Group on Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM); 2 Section of Clinical Biochemistry, University of Verona, Verona, Italy ; 3 Department of Medical Laboratory Diagnostics, University Hospital "Sveti Duh", Zagreb, Croatia ; 4 Department of Geriatrics, Hospital Universitario de Getafe, Getafe, Spain ; 5 Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, and STARD (Standards for Reporting of Diagnostic Accuracy) group, Amsterdam, the Netherlands ; 6 IRCCS Galeazzi and Vita e Salute San Raffaele University, Milan, Italy.

Annals of Translational Medicine
|June 9, 2016
PubMed
Summary

Many early-phase translational research studies fail due to practical issues like poor diagnostic testing and lab quality, wasting resources. Improving clinical trial success requires multidisciplinary collaboration and evidence-based biospecimen management.

Keywords:
Clinical trialspreanalytical variabilityqualitysafety

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