Data Governance for Real-World Evidence: Cross-country differences and

recommendations for a governance frameworkCole, A.1, Garrison, L.2, Mestre-Ferrandiz, J.1 & Towse A.1

Contact: acole@ohe.org 1Office of Health Economics, 2Universtiy of Washington

1. BACKGROUNDReal-world data (RWD) is information that can be used for health care decision-making which is collected outside of an experimental clinical trial setting. RWD is becoming increasingly important to:• Reflect outcomes in routine clinical practice• Meet the needs of regulators and payers, who are being

challenged to conduct earlier assessments under greater uncertainty, and monitoring outcomes throughout a product’s lifecycle

RWD becomes real-world evidence (RWE) – what is really of value to stakeholders – after a series of activities which facilitate the transformation of raw data into analysis and results. Robust and proportionate data governance, applied at each step, is essential in realising the value of RWD and its derivative RWE.

AcknowledgementsThis research was funded and initiated by Eli Lilly and Company

2. AIMS• To analyse the core governance arrangements for how RWD is

accessed or generated, and used credibly to provide evidence, in eight countries.

• To propose an aspirational governance framework.

3. METHODS• Investigate the governance arrangements in place in the UK,

France, Italy, Sweden, Germany, Netherlands, Australia, and the U.S.

• Use a structured pro-forma to assess core legislation for the collection and use of (both routinely-collected and de novo) data, data linkage opportunities, the data access environment, data use, and imminent changes to this landscape.

• Identify strengths and weaknesses in the current international approaches to data governance.

4.RESULTSIn order to utilise and derive value from RWD, appropriate and facilitative information governance is essential, thus transforming RWD into RWE.

5. DISCUSSION• Difficulties arise because RWD is

being used for purposes beyond those for which it was originally collected: to directly manage patient care.

• Legal frameworks are playing catch-up to accommodate these new secondary uses of data, which also benefit patients and society, but in a different way.

• By describing the process by which RWD (the raw data) is transformed into RWE (the insight), and assessing the rules and roles for information governance along this process in eight countries, we set out a framework for good governance which supports a favourable environment for RWE development and use.

• Countries have different approaches for achieving the balance between protecting privacy and supporting research that is in the public’s interest. In most cases the legal framework is not completely prescriptive, making a clear governance framework essential. 

• Appropriate and facilitative governance arrangements for RWE are imperative to facilitate evidence collection to meet the demands of regulators and HTA bodies, and to make the most of health care information and the role it can play in improving patient care.

Privacy interest

Public interest

Optimising R&D and treatment

targeting

Audit and service

evaluation

Research: effectiveness

and cost-effectiveness

Safeguarding against improper use of personal

information

Protecting patient identity

Recommendations for an ideal governance framework include:• Data protection legislation. There must be clear protection

requirements that recognise the legitimacy of health care data utilisation beyond the direct care of patients.

• Patient consent has a central role; where data collection is on a routine basis across a large patient cohort, an opt-out system of consent may be appropriate.

• There should be transparent mechanisms for data linkage which employ pseudonymisation tools to protect anonymity but maintain data integrity. For datasets to be compatible there needs to be a clear set of nationally agreed standards to optimise interoperability of health record systems.

UK US France Italy

Sweden Germany Netherlands Australia

We developed and outlined 29 elements of an ideal governance framework, and considered all countries against each criteria

Aligned with recommendationAspect addressed but room for improvement

Barrier or very problematic

Insufficient information to make a judgement

Current governance arrangements compare variably against our recommendations. For example, in Italy data collection is strong but access is poor. National data linkage networks, such as that established in Australia, offer huge potential. However, transparency is essential: UK and Netherlands provide examples of public trust breaking down, thus impeding RWD programmes. Sweden and the U.S. perform well across our proposed framework; Germany and France are more restrictive.

• Data access arrangements should be based on careful consideration of the motivation for and outputs of the research facilitated, rather than on the basis of the organisation’s status. Authorisation should be granted by approval panels which assess risks and benefits, implementing data use agreements as necessary.

6. CONCLUSION

• The core objective is to balance public and privacy interests: to advance our understanding of medical treatments through evaluation and research, on the one hand, and protect individuals’ privacy, on the other.