Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test
نویسندگان
چکیده
منابع مشابه
Exact Two-Stage Designs for Phase II Clinical Trials with Rank-Based Endpoints
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...
متن کاملOptimal two-stage designs for single-arm phase II oncology trials with two binary endpoints.
OBJECTIVES In phase II clinical trials in oncology, the potential efficacy of a new treatment regimen is assessed in terms of anticancer activity. The standard approach consists of a single-arm two-stage design where a single binary endpoint is compared to a specified target value. However, a new drug would still be considered promising if it showed a lower tumor response rate than the target l...
متن کاملOptimal two-stage designs for phase II clinical trials.
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 ...
متن کاملBayesian 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 ...
متن کاملOptimal designs for trials with discrete time survival endpoints
In studies on event occurrence the main question is whether and when a certain event occurs. Examples of events are smoking initiation, premature termination of therapy and recovery from some disease. The timing of such events cannot always be measured very precisely and coarse time intervals are used instead. At the end of each interval the occurrence of the event is measured, until and includ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Statistics in Medicine
سال: 2013
ISSN: 0277-6715
DOI: 10.1002/sim.6073