Methodological issues in drug assessment research

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Abstract
Increased sensitivity to methodological issues in drug assessment research is needed in light of challenges to research design, conduct, and outcomes. Major issues presented include (a) the nature and adequacy of placebo controls, (b) problems in maintaining the integrity of “blind” conditions, and (c) the potential design‐compromising effects of informed consent. The necessity of true matching placebos, particularly concerning physical/perceptual characteristics and the ability to produce transitory changes in subjects, was stressed. Though the double‐blind condition has conceptual integrity, the operation of drug and placebo side effects and associated guess bias may confound research results. Use of a triple‐blind condition and addition of a drug‐disguised group is suggested. Last, the issue of informed consent and its implications for the integrity of drug research is a problem deserving more attention.