Study-based registers of randomized controlled trials: Starting a systematic review with data extraction or meta-analysis
Adams, Clive E.
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Introduction: Despite years of use of study-based registers for storing reports of randomized controlled trials, the methodology used in developing such registers/databases has not been documented. Such registers are integral to the process of scientific reviewing. We document and discuss methodological aspects of the development and use of study-based registers. Although the content is focused on study-based register of randomized/controlled clinical trials, this work applies to developers of databases of all sorts of studies related to human, animal, cells, genes, and molecules. Methods: We describe necessity, rationale, and steps for development, utilization and maintenance of study-based registers as well as the challenges and gains for the organizations supporting systematic reviews of the published and unpublished literature. Conclusion: The ultimate goal of having a study-based register is to facilitate efficient production of systematic reviews providing rapid but accurate evidence for decision-makers. We argue that moving toward study-based registers is an inevitable welcome direction and that infrastructures are ready for such movement.