Identifying appropriate phase II trial designs
نویسندگان
چکیده
منابع مشابه
Identifying appropriate phase II trial designs
The phase II to III transition in the drug development process is associated with the highest risk compared to transition rates between other phases [1]. With increasing pressure to improve efficiency in this process it is essential that phase II trials are designed based on informed decisions, and to provide reliable results. With over 120 different phase II trial designs available [2], identi...
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Efficient development of targeted therapies that may only benefit a fraction of patients requires clinical trial designs that use biomarkers to identify sensitive subpopulations. Various randomized phase III trial designs have been proposed for definitive evaluation of new targeted treatments and their associated biomarkers (eg, enrichment designs and biomarker-stratified designs). Before proce...
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As the use of molecularly targeted agents, which are anticipated to increase overall survival (OS)and progression-free survival (PFS) but not necessarily tumor response, has increased in oncology, there has been a corresponding increase in the recommendation and use of randomized phase II designs. Such designs reduce the potential for bias, existent in comparisons with historical controls, but ...
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PURPOSE The best phase II design and endpoint for growth inhibitory agents is controversial. We simulated phase II trials by resampling patients from a positive (sorafenib vs. placebo; TARGET) and a negative (AE941 vs. placebo) phase III trial in metastatic renal cancer to compare the ability of various designs and endpoints to predict the known results. EXPERIMENTAL DESIGN A total of 770 and...
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T he failure rate for late-stage clinical trials in oncology is higher than that for any other area of medicine. Between 1991 and 2000, for example, 55% of phase III trials in oncology failed, compared with 30% in infectious disease and 20% in cardiology, according to a study by Schering-Plough and Merck investigators. A separate study from researchers at Princess Margaret Hospital in Toronto e...
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ژورنال
عنوان ژورنال: Trials
سال: 2011
ISSN: 1745-6215
DOI: 10.1186/1745-6215-12-s1-a87