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Studies Should Be Controlled, Randomized, and Blinded
Author(s) -
Parker RA
Publication year - 2009
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.2009.13
Subject(s) - blinding , randomization , placebo , randomized controlled trial , clinical pharmacology , treatment and control groups , clinical trial , medicine , psychology , alternative medicine , pharmacology , pathology
Rigorous assessment of the efficacy and safety of a new therapy requires a concurrent control group, randomization, and blinding. The control group allows comparison with a contemporaneous patient group. Randomization, properly done, avoids systematic bias between treatment groups and should balance other factors, reducing the likelihood of group differences due to patient characteristics. Blinding minimizes the risk of biases stemming from patients’ and assessors’ beliefs, actions, and hopes about the treatment received. This is critical given the substantial effect that such beliefs can have on outcome, often termed the “placebo effect.” New and exciting technologies would probably be particularly susceptible to the placebo effect, making blinding even more critical when studying such treatments. Clinical Pharmacology & Therapeutics (2009); 85 , 5, 461–463 doi: 10.1038/clpt.2009.13