Relative efficiency of precision medicine designs for clinical trials with predictive biomarkers
نویسندگان
چکیده
منابع مشابه
Clinical trials for predictive medicine.
Developments in biotechnology and genomics are providing a biological basis for the heterogeneity of clinical course and response to treatment that have long been apparent to clinicians. The ability to molecularly characterize human diseases presents new opportunities to develop more effective treatments and new challenges for the design and analysis of clinical trials. In oncology, treatment o...
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Evidence based medicine is very important for success of modern medicine. It is the ongoing process of using the most reliable evidence from clinical studies, scientific understanding and medical practice to make the best possible medical choice for patients. Evidence based medicine is how medicine advances and how we get improvements in life expectancy and quality of life. It not only identifi...
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PURPOSE Genomic technologies make it increasingly possible to identify patients most likely to benefit from a molecularly targeted drug. This creates the opportunity to conduct targeted clinical trials with eligibility restricted to patients predicted to be responsive to the drug. EXPERIMENTAL DESIGN We evaluated the relative efficiency of a targeted clinical trial design to an untargeted des...
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BACKGROUND Developments in biotechnology and genomics have increased the focus of biostatisticians on prediction problems. This has led to many exciting developments for predictive modeling where the number of variables is larger than the number of cases. Heterogeneity of human diseases and new technology for characterizing them presents new opportunities and challenges for the design and analy...
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An adaptive design allows the modifications of various features, such as sample size and treatment assignments, in a clinical study based on the analysis of interim data. The goal is to enhance statistical efficiency by maximizing relevant information obtained from the clinical data. The promise of efficiency, however, comes with a cost, per se, that is seldom made explicit in the literature. T...
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ژورنال
عنوان ژورنال: Statistics in Medicine
سال: 2017
ISSN: 0277-6715
DOI: 10.1002/sim.7562