Systematic reviews
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Systematic reviews, a cornerstone of evidence-based medicine, are not produced quickly enough to support clinical practice. The cost of production, availability of the requisite expertise and timeliness are often quoted as major contributors for the delay. This detailed survey of the state of the art of information systems designed to support or automate individual tasks in the systematic review, and in particular systematic reviews of randomized controlled clinical trials, reveals trends that see the convergence of several parallel research projects. ⋯ In this review, we describe each task and the effect that its automation would have on the entire systematic review process, summarize the existing information system support for each task, and highlight where further research is needed for realizing automation for the task. Integration of the systems that automate systematic review tasks may lead to a revised systematic review workflow. We envisage the optimized workflow will lead to system in which each systematic review is described as a computer program that automatically retrieves relevant trials, appraises them, extracts and synthesizes data, evaluates the risk of bias, performs meta-analysis calculations, and produces a report in real time.
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Editorial
Access to regulatory data from the European Medicines Agency: the times they are a-changing.
Systematic reviewers are increasingly trying to obtain regulatory clinical study reports (CSRs) to correct for publication bias. For instance, our organization, the Institute for Quality and Efficiency in Health Care, routinely asks drug manufacturers to provide full CSRs of studies considered in health technology assessments. However, since cooperation is voluntary, CSRs are available only for a subset of studies analysed. ⋯ The risk of other problems, such as conflicts of interest (CoIs) of independent researchers or quality issues can be reduced by transparency measures, such as the implementation of processes to evaluate CoIs and the publication of methods and protocols. In conclusion, regulatory data are an indispensable source for systematic reviews. Because of EMA's policy change, a milestone for data transparency in clinical research is within reach; let's hope it is not unnecessarily delayed.