期刊
CLINICAL PHARMACOLOGY & THERAPEUTICS
卷 85, 期 4, 页码 362-365出版社
WILEY
DOI: 10.1038/clpt.2008.192
关键词
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There are two interacting components in a clinical trial: the drug and the study design. When a trial does not work, we blame the drug-and the study is usually not published. This Commentary provides a context for the use of efficacy pipeline pharmacogenetics (PGx) in therapeutic programs. Jordan et al. published the results of an obesity trial with a cholecystokinin-A (CCK-A) receptor agonist and concluded that CCK-A by itself does not have a central role in long-term energy balance. The conclusions were sound, the report accurate, and the journal commendable for publishing a negative study, but the trial design was misdirected-it did not build on phase IIA information and did not test the proposed mechanism of action. The hypotheses should have been based on the original putative role of a central mechanism affecting appetite, which had been validated using efficacy PGx in phase IIA.
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