Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centresReportar como inadecuado




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Trials

, 11:79

First Online: 21 July 2010Received: 21 December 2009Accepted: 21 July 2010DOI: 10.1186-1745-6215-11-79

Cite this article as: Kuchinke, W., Ohmann, C., Yang, Q. et al. Trials 2010 11: 79. doi:10.1186-1745-6215-11-79

Abstract

BackgroundThe use of Clinical Data Management Systems CDMS has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at investigator sites with -electronic Case Report Forms-. Although more and more of these electronic data management systems are used in academic research centres an overview of CDMS products and of available data management and quality management resources for academic clinical trials in Europe is missing.

MethodsThe ECRIN European Clinical Research Infrastructure Network data management working group conducted a two-part standardized survey on data management, software tools, and quality management for clinical trials. The questionnaires were answered by nearly 80 centres-units with an overall response rate of 47% and 43% from 12 European countries and EORTC.

ResultsOur survey shows that about 90% of centres have a CDMS in routine use. Of these CDMS nearly 50% are commercial systems; Open Source solutions don-t play a major role. In general, solutions used for clinical data management are very heterogeneous: 20 different commercial CDMS products 7 Open Source solutions in addition to 17-18 proprietary systems are in use. The most widely employed CDMS products are MACRO™ and Capture System™, followed by solutions that are used in at least 3 centres: eResearch Network™, CleanWeb™, GCP Base™ and SAS™. Although quality management systems for data management are in place in most centres-units, there exist some deficits in the area of system validation.

ConclusionsBecause the considerable heterogeneity of data management software solutions may be a hindrance to cooperation based on trial data exchange, standards like CDISC Clinical Data Interchange Standard Consortium should be implemented more widely. In a heterogeneous environment the use of data standards can simplify data exchange, increase the quality of data and prepare centres for new developments e.g. the use of EHR for clinical research. Because data management and the use of electronic data capture systems in clinical trials are characterized by the impact of regulations and guidelines, ethical concerns are discussed. In this context quality management becomes an important part of compliant data management. To address these issues ECRIN will establish certified data centres to support electronic data management and associated compliance needs of clinical trial centres in Europe.

AbbreviationsCDISCclinical data interchange standard consortium

CDMclinical data management

CDMSclinical data management system

CRFcase report form

CRUclinical research unit

CTCclinical trial centre

DDEdouble data entry

DMdata management

ECRINEuropean clinical research infrastructure network

EDCelectronic data capture

EHRelectronic health record

EORTCEuropean organisation for research and treatment of cancer

ePROelectronic patient reported outcome

FDAfederal drug agency

GAMPgood automated manufacturing practice

GCPgood clinical practice

IHEintegrating the healthcare enterprise

INVESTinternational Verapamil SR Trandolapril study

ITinformation technology

LGPLGNU Lesser General Public License

RDEremote data entry

SMSshort message service

SOPstandard operating procedures

SVsystem validation

XMLextensible mark-up language.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-11-79 contains supplementary material, which is available to authorized users.

Wolfgang Kuchinke, Christian Ohmann contributed equally to this work.

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Autor: Wolfgang Kuchinke - Christian Ohmann - Qin Yang - Nader Salas - Jens Lauritsen - Francois Gueyffier - Alan Leizorovicz - Ca

Fuente: https://link.springer.com/







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