Process guide for inferential studies using healthcare data from routine clinical practice to evaluate causal effects of drugs (PRINCIPLED): considerations from the FDA Sentinel Innovation Center bmj.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from bmj.com Daily Mail and Mail on Sunday newspapers.
This Viewpoint argues that a hypothesis-centric approach to writing grant applications is problematic and instead suggests that funding applications should be e
Emulating a target trial reduces the potential for bias in observational comparative effectiveness research. Owing to feasibility constraints, large cohort studies often use electronic health records without validating key variables or collecting additional data. A case-control design allows researchers to validate, supplement, or collect additional data on key measurements in a much smaller sample compared with the entire cohort. In this article, Rasouli and colleagues describe methods to emulate a target trial using a nested case-control design, and provide a detailed guideline, an analytical program, and results of a clinical example.
#### Summary points
Randomized controlled trials are considered the ideal study design for comparative effectiveness research. Given that such trials are usually costly, lengthy, and, in some instances, unethical or infeasible, interest is increasing in using observational studies such as those conducted using data from electronic health records and
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