_Lecture notes_phasei

_Lecture notes_phasei - Phase I(Dose-finding and...

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Unformatted text preview: Phase I (Dose-finding and Dose-ranging) Trials A Phase I trial is designed to find the best dosage of a drug to use in human subjects. • Dosage includes both amount of drug and frequency of administration. • Usually the first studies of the treatment in human subjects. • Often you want the highest tolerated dosage (cancer drugs) but sometimes the lowest dose that is active (vaccine that induces immune response). • Other study aims: Characterize types of side effects (symptoms, organ systems) Any evidence that drug is working Pharmacokinetics (when does it peak, where, how long before it is eliminated from body) Dose-ranging trials Piantadosi distinguishes between trials where the drug dosages or design points are specified in advance ( dose-ranging studies) and those where the dosages are not pre-specified but may be determined iteratively to produce an optimal dose. Dose ranging trials prototype: Phase I cancer chemotherapy • Goal: find maximum tolerated dose (MTD). • Start low, escalate sequentially until you get too many adverse reactions. • Storer (1989) proposed a widely used design as follows: 1. Treat 3 patients at current dose....
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_Lecture notes_phasei - Phase I(Dose-finding and...

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