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.
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.
authors.affiliation: Institute of Epidemiology and Medical Biometry, Ulm University , Ulm , Germany.
authors.forename: Dietrich
authors.initials: D
authors.lastname: Rothenbacher
authors.forename: Gorana
authors.initials: G
authors.lastname: Capkun
authors.forename: Hatice
authors.initials: H
authors.lastname: Uenal
authors.forename: Hayrettin
authors.initials: H
authors.lastname: Tumani
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Geissbühler
authors.forename: Hugh
authors.initials: H
authors.lastname: Tilson
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods; D016208:Databases, Factual / Q000706:statistics & numerical data; D015195:Drug Design; D006801:Humans; D009103:Multiple Sclerosis / Q000188:drug therapy*; D018570:Risk Assessment / Q000379:methods*
keywords: Benefit; Comparative effectiveness; Multiple sclerosis; Observational data; Real-world evidence; life-cycle management; risk assessment