Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials

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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...

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Dose-finding in phase I clinical trials based on toxicity probability intervals.

BACKGROUND Most phase I clinical trials conducted at the M. D. Anderson Cancer Center use the algorithmic 3 + 3 design, despite the availability of more advanced model-based designs such as the continual reassessment method. PURPOSE Through simple statistical modeling and computing, we develop a dose-finding design that can be easily understood and implemented by non-statisticians. METHODS ...

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Promoting Factors and Barriers to Participation in Early Phase Clinical Trials: Patients Perspectives.

BACKGROUND Inclusion of minorities in clinical research is an essential step to develop novel cancer treatments, improve health care overall, understand potential differences in pharmacogenomics and address minorities' disproportionate cancer burden. However, Latinos and other minority groups continue to be critically underrepresented, particularly in early-phase clinical trials (EPCTs). The ob...

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ژورنال

عنوان ژورنال: Cancer

سال: 2004

ISSN: 0008-543X,1097-0142

DOI: 10.1002/cncr.20730