The Redesign of Clinical Trials

The exclusion of particular groups from clinical trials, such as women, elderly people, children, and ethnic minorities, has long been problematic (24). Exclusion on the basis of genotype raises similar difficulties about the loss of benefits from research participation and unfair representation in the trial and raises issues about the justice of such research (17). Moreover, major technical issues surround the reliability and validity of clinical trials designed and streamlined according to genomic criteria. These include statistical problems with small subdivided patient samples, reduced chances of detecting rare ADRs, sample bias, lack of consistency in controlling for pharmacogenetic variables in multicenter trials, and difficulty in replicating genetic association studies (17). As a consequence, regulatory authorities are taking a cautious approach to the redesign of trials, as this may increase the possibility of unsafe medicines reaching the market. The FDA has initially indicated that the pharmacogenetic arm of any pivotal trial will be additional to normal trial procedures. If trials ultimately contain an element of selection based on genotype, there may be a greater need for tight clinical governance and improved postmarketing surveillance.

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