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- W2114505662 abstract "The assessment and demonstration of a positive benefit–risk balance of a drug is a life-long process and includes specific data from preclinical, clinical development and post-launch experience. However, new integrative approaches are needed to enrich evidence from clinical trials and sponsor-initiated observational studies with information from multiple additional sources, including registry information and other existing observational data and, more recently, health-related administrative claims and medical records databases. To illustrate the value of this approach, this paper exemplifies such a cross-package approach to the area of multiple sclerosis, exploring also possible analytic strategies when using these multiple sources of information." @default.
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- W2114505662 date "2015-04-02" @default.
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- W2114505662 title "New opportunities of real-world data from clinical routine settings in life-cycle management of drugs: example of an integrative approach in multiple sclerosis" @default.
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- W2114505662 doi "https://doi.org/10.1185/03007995.2015.1027677" @default.
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