Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards

BMC Medical Informatics and Decision Making

Research Article

Hans Hillege¹  Gert van Valkenhoef²  Tommi Tervonen³  Bert de Brock⁴ 

[1] Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;Faculty of Economics and Business, University of Groningen, Groningen, The Netherlands;Econometric Institute, Erasmus University Rotterdam, Rotterdam, The Netherlands;Faculty of Economics and Business, University of Groningen, Groningen, The Netherlands;

关键词: Clinical Trial Result;    Systematic Reviewer;    Clinical Trial Evidence;    International Clinical Trial Registry Platform;    Clinical Trial Information;   

DOI  :  10.1186/1472-6947-12-95

 received in 2011-09-27, accepted in 2012-08-24,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundDecisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Unfortunately, finding the relevant clinical trials is difficult and their results are only available in text-based reports. Systematic reviews aim to provide a comprehensive overview of the evidence in a specific area, but may not provide the data required for decision making.MethodsWe review and analyze the existing information systems and standards for aggregate level clinical trials information from the perspective of systematic review and evidence-based decision making.ResultsThe technology currently used has major shortcomings, which cause deficiencies in the transfer, traceability and availability of clinical trials information. Specifically, data available to decision makers is insufficiently structured, and consequently the decisions cannot be properly traced back to the underlying evidence. Regulatory submission, trial publication, trial registration, and systematic review produce unstructured datasets that are insufficient for supporting evidence-based decision making.ConclusionsThe current situation is a hindrance to policy decision makers as it prevents fully transparent decision making and the development of more advanced decision support systems. Addressing the identified deficiencies would enable more efficient, informed, and transparent evidence-based medical decision making.

【 授权许可】

CC BY   
© Van Valkenhoef et al.; licensee BioMed Central Ltd. 2012