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Abstract:
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Precision medicine clinical trials are poised to revolutionize healthcare, supported by advanced clinical development technologies. These can harness diverse, rich, disparate data sources to build more accurate predictive models for different patient subsets. We discuss the nature of precision medicine; FDA initiatives for development of targeted therapies; the impact of the revolution in genomics on precision medicine; the 5 Vs of big data; and the pivotal role of big data in precision medicine. Four clinical trial technologies provide essential capabilities for precision medicine: 1) Continuous collection, aggregation, and integration of myriad data sources; 2) Adaptive and iterative study design and execution as new information becomes available; 3) Management of data throughout the study life cycle; 4) Advanced analytics for research discovery. Precision medicine shows great promise for developing and evaluating exploratory hypotheses and producing safer, more effective treatments for targeted patient subsets with advantageous benefit-risk profiles. Complex precision medicine study designs require substantial planning, investment, and commitment from all parties.
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