Brian McCourt Director, Clinical Research Informatics 24 Mar 2014

Linking, Accessing, Governing and Security of Electronic Registries:The Value of Global Essential Principles Brian McCourt Director, Clinical Research Informatics 24 Mar 2014

Creating Shared ValueMichael E. Porter and Mark R. KramerHBR January 2011http://hbr.org/2011/01/the-big-idea-creating-shared-value/ar/1 Shared value is not social responsibility, philanthropy, or even sustainability, but a new way to achieve economic success. It is not on the margin of what companies do but at the center. We believe that it can give rise to the next major transformation of business thinking. … And government must learn how to regulate in ways that enable shared value…

Organizational Value Shared Value

Organizational value of principles [for linking data sets and applying analytic methods] • Consensus on essential principles promote consistency, predictability, transparency and international regulatory convergence • Reduced risks of innovation • Faster research, surveillance and product development cycles • Efficiency of operations for data-driven initiatives • Trust of data and the reproducibility and reliability of findings

Data Governance • Traditional data governance in registries has been served by a publications committee. • Increasingly ‘data governance’ spans the data lifecycle from adoption of data standards to access policies to data retention. • Multiple uses of data maximizes its value, but creates an multi-dimensional web of requirements and expectations.

Data Governance Patient Intellectual Property Authorization Consent Future Use Regulatory Corporate IP Public funding Academic policy Licensing/partnerships Privacy Laws Operations\Quality vs Research? Business Agreements

Presented by Sharon Terry NIH Collaboratory Grand Rounds, Feb 21, 2014 www.nihcollaboratory.org/Pages/GR%20Slides%2002-21-14.pdf

http://transparency.efpia.eu/uploads/Modules/Documents/data-sharing-prin-final.pdfhttp://transparency.efpia.eu/uploads/Modules/Documents/data-sharing-prin-final.pdf

Enabling governance models within data systems – federated networks Query Results

Opportunities for shared value • Distributed networks require consistency and thoroughly defined data definitions, data models and understanding of the context of data collection • Data quality issues: e.g. skewed processes, non-random missingness • Technology barriers to data sharing have decreased revealing limitations in governance, data management and analytical methods • More data exists than we understand how to use

Example Essential Principles • Patient privacy should be protected • AdvaMedRegistry Principles - 2013 • Data Partners have the best understanding of their data and it’s uses; valid use and interpretation of findings requires input from the Data Partners. • Mini-Sentinel Common Data Model Guiding Principles • We will leverage the latest data standards practical for our purpose. • All transformations, calculations, imputations and assumptions will be documented and maintained alongside the data.

Remember doing research before PubMed? Remember doing research before we understood how to reuse data?

Brian McCourt Director, Clinical Research Informatics 24 Mar 2014