Extended two-stage adaptive designs with three target responses for phase II clinical trials
نویسندگان
چکیده
منابع مشابه
Bayesian two-stage designs for phase II clinical trials.
Many different statistical designs have been used in phase II clinical trials. The majority of these are based on frequentist statistical approaches. Bayesian methods provide a good alternative to frequentist approaches as they allow for the incorporation of relevant prior information and the presentation of the trial results in a manner which, some feel, is more intuitive and helpful. In this ...
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The primary objective of a phase II clinical trial of a new drug or regimen is to determine whether it has sufficient biological activity against the disease under study to warrant more extensive development. Such trials are often conducted in a multi-institution setting where designs of more than two stages are difficult to manage. This paper presents two-stage designs that are optimal in the ...
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BACKGROUND Simon's two-stage design is the most widely implemented among multi-stage designs in phase II clinical trials to assess the activity of a new treatment in a single-arm study. In this two-stage design, the sample size from the second stage is fixed regardless of the number of responses observed in the first stage. METHODS We develop a new minimax adaptive design for phase II clinica...
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Features common to Phase II clinical trials include limited knowledge of the experimental treatment being evaluated, design components reflecting ethical considerations, and small to moderate sample sizes as a result of resource constraints. It is for these reasons that there exist many two-stage designs proposed in the literature for use in this context. The majority of these designs are for b...
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The role of Phase II trials in oncology drug development Traditionally, Phase II in oncology drug development acts as a screening tool by identifying treatments with sufficient activity that warrant further investigation in large and costly Phase III studies. However, Phase II has also another more prominent role in cancer research as there is a significant number of drugs that were approved ba...
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ژورنال
عنوان ژورنال: Statistical Methods in Medical Research
سال: 2017
ISSN: 0962-2802,1477-0334
DOI: 10.1177/0962280217709817