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Users' Guides to the Medical Literature
Guyatt G, Rennie D, Meade MO, Cook DJ
Part B Therapy
Chapter 9.2. Surprising Results of Randomized Trials
Christina Lacchetti, John Ioannidis, Gordon Guyatt
Most Major Basic Science and Preclinical Promises for Effective Interventions Disappoint in Clinical Trials


Topics Discussed: evidence, interpretation of results, patient-important outcome, randomized controlled trials

Excerpt: "Ideally, evidence for the effectiveness of diagnostic, preventive, or therapeutic interventions will come from rigorous randomized controlled trials (RCTs) measuring effects on patient-important outcomes such as stroke, myocardial infarction, and death. Historically, however, clinicians have often relied on weaker evidence. Whenever an intervention is tested to see whether it is effective or not for patient-important outcomes, typically some other evidence of variable quantity and quality already exists. This evidence includes combinations of basic science findings, preclinical results, observational studies, and earlier phase I or II clinical trials...."
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