SMART Safety: a large empirical database for systematic reviews of adverse events

Evidence synthesis serves an important role to promote informed decision-making in healthcare practice. A key issue of evidence synthesis is the approach to deal with rare adverse events and the methods to address bias of harm effects. Empirical data is essential to help methodologists and statisticians to solve the issues in evidence synthesis of adverse events. For this reason, we have established SMART Safety dataset, the largest empirical dataset of meta-analyses of adverse events. The dataset contains 151 systematic reviews with 629 meta-analyses on safety outcomes, which covers more than 2,300 randomized controlled trials and 362 harm outcomes, with 10,069 rows and 42 columns of trial level information. All information was double- or even quadra-checked and further verified by referring the original source (e.g., the full-text of the included randomized trials) to ensure high validity of the data.