White Paper

The Role Of Observational Research & Patient Registries In Evidence Generation

Source: Worldwide Clinical Trials

By Michael F. Murphy, M.D. Ph.D., Lorna M. Graham, MSc, Alexandria Malouvier, Ph.D.

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The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes.  Neither orderly, nor fully rational, these often conflicting perspectives require access to a portfolio of interventional and observational research designs subserving different objectives, and tiered in importance and timing during the drug development cycle. Increasingly central is the inclusion of observational studies, including registries which provide insights missing from traditional interventional studies encountered in the course of drug development.