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Keywords: Clinical trial; Continual reassessment method; Dose finding; Early termination; Phase 1 designs; Sample size; Stopping rules. 1. INTRODUCTION.
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Log out of ReadCube. 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.


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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. The full text of this article hosted at iucr. If you do not receive an email within 10 minutes, your email address may not be registered, and you may need to create a new Wiley Online Library account.

A dynamic stopping rule for phase I clinical trials

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Challenges of early phase oncology dose-finding clinical trials

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Innovations In Continuous Internal Assessment English Language Essay

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Innovations In Continuous Internal Assessment English Language Essay

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    Adaptive Designs: Early Phase Trials

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