New Opportunities Of Real-World Data From Clinical Routine Settings In Life-Cycle Management Of Drugs: Example Of An Integrative Approach In Multiple Sclerosis

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.