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• W2342559938 abstract "Randomized controlled clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of pharmaceutical drugs, but in many cases their costs, duration, limited generalizability, and ethical or technical feasibility have caused some to look for real-world studies as alternatives. However, real-world studies may be less convincing due to the lack of randomization and blinding. In this article, we discuss some key considerations in the design of real-world studies, which include experimental studies (e.g., hybrid or pragmatic clinical trials and non-randomized single-arm clinical trials with external controls) and non-experimental studies (e.g., cohort studies, cross-sectional studies, and case-control studies). Causal inference plays a critical role in the derivation of robust real-world evidence (RWE) from the analysis of real-world data (RWD). Therefore, we apply the hypothetical strategy, along with the concept of potential outcome, to lay out these key considerations, and we hope these considerations are helpful for the design, conduct, and analysis of real-world studies." @default.
• W2342559938 created "2016-06-24" @default.
• W2342559938 creator A5018255263 @default.
• W2342559938 creator A5048323837 @default.
• W2342559938 date "1955-01-01" @default.
• W2342559938 modified "2023-09-25" @default.
• W2342559938 title "Management of Adrenocortical Insufficiency" @default.
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• W2342559938 doi "https://doi.org/10.1016/s0025-7125(16)34762-9" @default.
• W2342559938 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/13234930" @default.
• W2342559938 hasPublicationYear "1955" @default.
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