Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMC Med Inform Decis Mak. 2012 Sep 4;12:95. doi: 10.1186/1472-6947-12-95.
Decisions 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.
We 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.
The 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.
The 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.
药物安全性和疗效的决策通常基于临床试验提供的关键证据。然而，找到相关的临床试验是困难的，其结果仅以文本报告的形式提供。系统评价旨在对特定领域的证据进行全面概述，但可能无法提供决策所需的数据。
我们从系统评价和循证决策的角度审查和分析现有的汇总水平临床试验信息的信息系统和标准。
现有技术存在重大缺陷，导致临床试验信息的传递、可追溯性和可用性存在不足。具体来说，决策者可用的数据结构不充分，因此无法正确追溯决策所依据的证据。监管提交、试验发表、试验注册和系统评价产生的非结构化数据集不足以支持循证决策。
当前的情况阻碍了政策决策者，因为它使完全透明的决策和更先进的决策支持系统的开发变得困难。解决已确定的缺陷将能够实现更高效、知情和透明的循证医学决策。
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