Abstract
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.
Highlights
Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials
Doing so requires access to the underlying trial data, but these are not commonly reported. This is a serious limitation to the efficiency of both evidence-based decision making and systematic reviewing
Scope and objectives The aim of this paper is to identify opportunities to enhance the efficiency of systematic review and evidencebased decision making, supported by a broad and useful overview of the current state of the art in the transfer and availability of clinical trial evidence
Summary
Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Finding the relevant clinical trials is difficult and their results are only available in text-based reports. Clinical trials provide the pivotal evidence for drug efficacy and safety. The ability to efficiently identify and make use of the results of existing clinical trials is critical to evidence-based policy decision making. Even when a relevant systematic review is available, there may be a need to go back to the underlying trial data, especially for quantitative decision modeling. Doing so requires access to the underlying trial data, but these are not commonly reported. This is a serious limitation to the efficiency of both evidence-based decision making and systematic reviewing
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