Targeting targeted agents: open issues for clinical trial design
نویسندگان
چکیده
منابع مشابه
Targeting targeted agents: open issues for clinical trial design
Molecularly targeted agents for the treatment of solid tumors had entered the market in the last 5 years, with a great impact upon both the scientific community and the society. Many randomized phase III trials conducted in recent years with new targeted agents, despite previous data coming from preclinical research and from phase II trials were often promising, have produced disappointingly ne...
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With an increasing number of targeted agents available for testing, clinical trials must be rationally designed based on sound knowledge of the molecular mechanisms linking target and disease, fortified by strong preclinical data demonstrating how this relationship is modified by the targeted agent. Patients and resources are precious and should be expended judiciously on clinical trials that a...
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PURPOSE Cancer therapies with mechanisms of action which are very different from the more conventional chemotherapies are now being developed. In this article, we investigate the performance of several phase III clinical trial designs, both for testing the overall efficacy of a targeted agent and for testing its efficacy in a subgroup of patients with a tumor marker present. We study different ...
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The past 40 years have seen significant improvements in both event-free and overall survival for children with acute lymphoblastic and acute myeloid leukemia (ALL and AML, respectively). Serial national and international clinical trials have optimized the use of conventional chemotherapeutic drugs and, along with improvements in supportive care that have enabled the delivery of more intensive r...
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This paper reviews some of the more salient recent developments in statistical aspects of clinical trial design methodology and suggests that more emphasis be placed on rigorous assessments of the new methodologies to place them in the context of existing methods, demonstrate their claimed advantages, and fully disclose their remaining limitations.
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ژورنال
عنوان ژورنال: Journal of Experimental & Clinical Cancer Research
سال: 2009
ISSN: 1756-9966
DOI: 10.1186/1756-9966-28-66