Phase I Clinical Trials
نویسندگان
چکیده
منابع مشابه
Phase I clinical trials
Phase I trials are conducted to find a dose to use in subsequent trials. They provide data on the rate of adverse events at different dose levels and provide data for studying the pharmacokinetics and pharmacology of the drug. Dose-finding studies that involve therapies with little or no toxicity often enroll healthy volunteers and usually have a control group. Trials in oncology and other life...
متن کاملBayesian Optimal Interval Designs for Phase I Clinical Trials
In phase I trials, effectively treating patients and minimizing the chance of exposing them to subtherapeutic and overly toxic doses are clinician’s top priority. Motived by this practical consideration, we propose Bayesian optimal interval (BOIN) designs to find the maximum tolerated dose (MTD) and minimize the probability of inappropriate dose assignments for patients. We show, both theoretic...
متن کاملAccelerated titration designs for phase I clinical trials in oncology.
BACKGROUND Many cancer patients in phase I clinical trials are treated at doses of chemotherapeutic agents that are below the biologically active level, thus reducing their chances for therapeutic benefit. Current phase I trials often take a long time to complete and provide little information about interpatient variability or cumulative toxicity. PURPOSE Our objective was to develop alternat...
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We thankDienstmann andTabernero for their comments on our article (1). They underscore the high translational potential of using tumor growth rates (TGR) to assess the therapeutic effect independently from the natural course of the disease and ultimately guide the "go no go decision making" in early drug development setting. Dienstmann and Tabernero mention that rapid progressionmayoccur at tre...
متن کاملA random walk rule for phase I clinical trials.
We describe a family of random walk rules for the sequential allocation of dose levels to patients in a dose-response study, or phase I clinical trial. Patients are sequentially assigned the next higher, same, or next lower dose level according to some probability distribution, which may be determined by ethical considerations as well as the patient's response. It is shown that one can choose t...
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ژورنال
عنوان ژورنال: CA: A Cancer Journal for Clinicians
سال: 1987
ISSN: 0007-9235
DOI: 10.3322/canjclin.37.4.256-a