Study Designs for Clinical Trial using Biomarker
نویسندگان
چکیده
منابع مشابه
Biomarker informed adaptive clinical trial designs
In adaptive design clinical trials, an endpoint at the final analysis that takes a long time to observe is not feasible to be used for making decisions at the interim analysis. For example, overall survival (OS) in oncology trials usually cannot be used to make interim decisions. However, biomarkers correlated to the final clinical endpoint can be used. Hence, considerable interest has been dra...
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BACKGROUND Advances in molecular therapeutics in the past decade have opened up new possibilities for treating cancer patients with personalized therapies, using biomarkers to determine which treatments are most likely to benefit them, but there are difficulties and unresolved issues in the development and validation of biomarker-based personalized therapies. We develop a new clinical trial des...
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Cancers of the same primary site are in many cases heterogeneous in molecular pathogenesis, clinical course, and treatment responsiveness. Current approaches for treatment development, evaluation, and use result in treatment of many patients with ineffective drugs and lead to the conduct of large clinical trials to identify small, average treatment benefi ts for heterogeneous groups of patients...
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PURPOSE Biomarkers can add substantial value to current medical practice by providing an integrated approach to prediction using the genetic makeup of the tumor and the genotype of the patient to guide patient-specific treatment selection. We discuss and evaluate various clinical trial designs for the validation of biomarker-guided therapy. METHODS Designs for predictive marker validation are...
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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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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2012
ISSN: 0923-7534
DOI: 10.1016/s0923-7534(20)32138-4