Data Governance Arrangements for Real-World Evidence

Cole, A., Garrison, L., Mestre-Ferrandiz, J. and Towse, A.

Consulting Report
November 2015

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The objective of this OHE Consulting Report was to understand and develop a view on the core principles that should govern how Real-World Data (RWD) is accessed or generated, and used credibly to produce or generate Real-World Evidence (RWE), thereby working toward a set of “international standards”.

In this report, we firstly outline models of data governance in eight key markets: the UK, France, Italy, Sweden, Germany, the Netherlands, Australia and the U.S. With the insights generated from these case studies, we then develop an illustrative framework of a top-performing governance model. By defining this model, we provide recommendations of what constitutes a good governance framework, which will support the favourable environment for the creation of RWE.