New opportunities of real-world data from clinical routine settings in life-cycle management of drugs: example of an integrative approach in multiple sclerosis |
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| Authors: | Dietrich Rothenbacher Gorana Capkun Hatice Uenal Hayrettin Tumani Yvonne Geissbühler Hugh Tilson |
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| Affiliation: | 1. Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany;2. Global Patient Access, Novartis Pharma AG, Basel, Switzerland;3. Department of Neurology, Ulm University, Ulm, Germany;4. Quantitative Safety &5. Epidemiology, Novartis Pharma AG, Basel, Switzerland;6. Gillings School of Global Public Health University of North Carolina, Chapel Hill, USA |
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| 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. |
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| Keywords: | Benefit risk assessment Comparative effectiveness life-cycle management Multiple sclerosis Observational data Real-world evidence |
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