Standardizing in vitro diagnostics tasks in clinical trials: a call for action.
Translational research is defined as the process of applying ideas, insights and discoveries generated through basic scientific inquiry to treatment or prevention of human diseases. Although precise information is lacking, several lines of evidence attest that up to 95% early-phase studies may not translate into tangible outcomes for improving clinical management. Major theoretical hurdles exist in the translational process, but is it also undeniable that many studies may have failed for practical reasons, such as the use of inappropriate diagnostic testing for evaluating efficacy, effectiveness or safety of a given medical intervention, or poor quality in laboratory testing. This can generate biased test results and result in misconceptions during data interpretation, eventually leading to no clinical benefit, possible harm, and a waste of valuable resources. From a genuine economic perspective, it can be estimated that over 10 million euros of funding may be lost each year in clinical trials in the European Union due to preanalytical and analytical problems. These are mostly attributions to the heterogeneity of current guidelines and recommendations for the testing process, to the poor evidence base for basic pre-analytical, analytical and post-analytical requirements in clinical trials, and to the failure to thoughtfully integrate the perspectives of clinicians, patients, nurses and diagnostic companies in laboratory best practices. The most rational means for filling the gap between what we know and what we practice in clinical trials cannot discount the development of multidisciplinary teams including research scientists, clinicians, nurses, patients associations and representative of in vitro diagnostic (IVD) companies, who should actively interplay and collaborate with laboratory professionals to adapt and disseminate evidence-based recommendations about biospecimen collection and management into the research settings, from preclinical to phase III studies.
1 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.
Giuseppe
G
Lippi
1 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.
Ana-Maria
AM
Simundic
1 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.
Leocadio
L
Rodriguez-Manas
1 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.
Patrick
P
Bossuyt
1 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.
Giuseppe
G
Banfi
Clinical trials; preanalytical variability; quality; safety