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Integrated Efficacy to Effectiveness Trials
Author(s) -
Califf R M
Publication year - 2014
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2013.232
Subject(s) - clinical trial , intervention (counseling) , medical physics , computer science , medicine , nursing
Experts in clinical research, therapeutic development, and comparative effectiveness are continually frustrated in their attempts to fit the square peg of therapeutic development into the round hole of clinical trials. Trials can be optimized to provide signals in highly controlled experiments or to estimate an intervention's effect in poorly controlled real‐world settings, but not both simultaneously. Selker and colleagues propose a continuum that creates a smooth transition from controlled experiments to real‐world, real‐time studies within a single mechanism. Clinical Pharmacology & Therapeutics (2014); 95 2, 131–133. doi: 10.1038/clpt.2013.232