Randomized Phase II Designs
نویسندگان
چکیده
منابع مشابه
Randomized phase II designs.
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 ...
متن کاملRandomized phase II trial designs with biomarkers.
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...
متن کاملIdentifying 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...
متن کاملAdaptive designs for Phase II oncology trials
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...
متن کاملPerformance of multinomial designs in comparison with response-based designs in non-randomized phase II trials of targeted cancer agents.
BACKGROUND In phase II trials of cytotoxic agents, a multinomial phase II design incorporating early progression and response end points was shown to perform more efficiently than designs based only on response. We undertook a study to evaluate the performance of these designs in trials of targeted agents using the actual phase II data. PATIENTS AND METHODS Using best response data from seque...
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ژورنال
عنوان ژورنال: Clinical Cancer Research
سال: 2009
ISSN: 1078-0432,1557-3265
DOI: 10.1158/1078-0432.ccr-08-2031