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• W1503239620 abstract "Abstract Phase I trials, which are also called first‐into‐human studies, try to determine dosing, to document how a drug is metabolized and excreted, and to identify acute side effects. Usually, a small number of healthy volunteers (between 20 and 40) is used. They evaluate how well a new drug is tolerated, with the principal observations of interest being the pharmacokinetic and pharmacodynamic endpoints. Designs are often fixed, in which several dose levels and a placebo are randomly given, possibly in different periods, although some ascension is often conducted over the periods. At the other end of the severity spectrum, oncology Phase I trials are conducted in patients to determine the highest dosage that can be given safely, which is usually called the maximum tolerated dose (MTD). The designs are sequential and adaptive in some sense, because each patient is administered a dose level on the light of previous doses, and outcomes are observed in the trial. Two main adaptive designs are used, with dose allocation either algorithm‐ or model‐guided. They differ in terms of underlying interpretation of the MTD. The aim of this article is to summarize the most usual Phase I designs and analyses conducted in healthy volunteers and in oncology patients, separately. Differences between these approaches are stressed out, with some practical recommendations." @default.
• W1503239620 created "2016-06-24" @default.
• W1503239620 creator A5052673276 @default.
• W1503239620 date "2008-09-19" @default.
• W1503239620 modified "2023-10-17" @default.
• W1503239620 title "Phase I Trials" @default.
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• W1503239620 doi "https://doi.org/10.1002/9780471462422.eoct618" @default.
• W1503239620 hasPublicationYear "2008" @default.
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