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Data Governance For Real-World Evidence: Cross-Country Differences And Recommendations For A Governance Framework

      Objectives

      The environment for collecting real-world data (RWD) to support decision-making is changing. Increasingly, regulators are monitoring benefits and risks throughout a medicine’s lifecycle. Payers are similarly being challenged to conduct earlier value assessments under greater uncertainty, and re-visiting assessments as further RWD is collected. RWD becomes real-world evidence (RWE) by a series of activities that transform raw data into analysis and results. Robust and appropriate data governance, applied at each step, are essential to realising the value of RWD. In this study, we analyse data governance in eight countries, and propose an aspirational governance framework.

      Methods

      Current data governance arrangements in eight countries were assessed: the UK, France, Italy, Sweden, Germany, the Netherlands, Australia and the U.S. By identifying strengths and weaknesses, we develop an illustrative framework of a top-performing data governance model.

      Results

      There was significant country variation in data collection and use. Appropriate and facilitative information governance, along with public trust, is key to realising the benefits of scientific research. Patient consent has a central role, alongside transparent mechanisms for data linkage, anonymisation, and authorisation. Current governance arrangements compare more/less favourably against our recommendations depending on the country and criteria. For example, in Italy data collection is strong but access is poor. Sweden and the U.S. perform well across our proposed framework; Germany and France are more restrictive.

      Conclusions

      As a core objective, data governance arrangements must balance public and privacy interests: in advancing our understanding of medical treatments through evaluation and research, on the one hand, and protecting individuals’ privacy, on the other. Countries have different approaches, and in most cases the legal framework is not completely prescriptive: this makes a clear governance framework essential. We propose recommendations to work towards international standards for a more facilitative environment for the transformation of RWD into RWE.