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- W3125453455 endingPage "e863" @default.
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- W3125453455 abstract "In Brief This article presents an overview of fundamental statistical principles of clinical trials of pain treatments. Statistical considerations relevant to phase 2 proof of concept and phase 3 confirmatory randomized trials investigating efficacy and safety are discussed, including (1) research design; (2) endpoints and analyses; (3) sample size determination and statistical power; (4) missing data and trial estimands; (5) data monitoring and interim analyses; and (6) interpretation of results. Although clinical trials of pharmacologic treatments are emphasized, the key issues raised by these trials are also directly applicable to clinical trials of other types of treatments, including biologics, devices, nonpharmacologic therapies (eg, physical therapy and cognitive-behavior therapy), and complementary and integrative health interventions. Fundamental statistical considerations relevant to phase 2 proof of concept and phase 3 confirmatory randomized trials investigating the efficacy and safety of pain treatments are reviewed." @default.
- W3125453455 created "2021-02-01" @default.
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- W3125453455 creator A5089384391 @default.
- W3125453455 date "2020-12-18" @default.
- W3125453455 modified "2023-10-14" @default.
- W3125453455 title "Essential statistical principles of clinical trials of pain treatments" @default.
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