Ну раз уж заговорили про антикоагулянты, вот Вам ещё свежачок:
Pharmacogenomics: will the promise be fulfilled? Nature Reviews Genetics, January 2011, p. 69-73.
- Pharmacogenomics has, beyond any doubt, contributed to our understanding of
the mechanisms of interpatient variability in drug response. [...] For example, clinical trials aimed at testing the relevance of adjusting the dose of the anticoagulant warfarin according to genotype16
may take so much time that, by the time the results are available, warfarin will have been replaced by new compounds. (Heyo K. Kroemer)
- Third, and perhaps most importantly, we need to oppose the idea that every pharmacogenetic intervention requires a randomized controlled trial (RCT) to prove its superiority over the existing standard of care. Of course, there should be evidence of efficacy, but the level of evidence needs to match the clinical stakes. RCTs should be reserved for high-stakes prescribing decisions (involving lots of risk to the patient (as in the case of cancer) and/or many patients (as in the case of anticoagulation therapy)). Other levels of evidence may be sufficient to justify the preliminary testing of pharmacogenetics in clinical settings. (Russ B. Altman)
Сдается мне, что фраза о применимости РКИ справедлива не только для фармакогенетики.
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