CONTEXT: Fairly simplistic article on RWD reporting on an article from an orthopaedic journal | More evidence of the spread of RWR and the newer statistical methods coming into play to make the best use of RWD.
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1. “A new supplement article in the March 1, 2021 edition of the Journal of Orthopaedic Trauma (“Real-World Evidence: A Primer”) is shedding light on the growth and utility of “real world data” (RWD).”
2. ““Real world evidence is the clinical evidence derived from analysis of this real-world data that evaluates the risk and benefits of a given medical product.”
3. “Such evidence can be generated through a number of study designs or analyses, such as traditional randomized controlled trials (RCTs), or in our case, through a large-scale observational study.””
4. “Pragmatic clinical trials on the rise, say the authors, and propensity score statistical methods allows for an alternative to randomized trials using RWD.”
5. “To date, RWD has been used for the following purposes:. Safety MonitoringExternal Comparators (aka historic or synthetic controls)Broad Population ReachImproved Clinical Trial EfficiencyRegulatory Approvals Hypothesis Generation and Predicate Free AnalysisPolicy and Reimbursement Decisions. Concerns remain. Data Quality: Variety and Veracity—standardization of formats for data sets, protocols, and tools to ensure reproducibility, for example.”
Source URL: https://orthospinenews.com/2021/03/05/beyond-rcts-real-world-data/