Policy recommendations for sharing data in the US Cancer Moonshot project

In his 2016 State of the Union Address, former U.S. president Barack Obama announced a “Cancer Moonshot” project to dramatically accelerate cancer research and improved prevention, diagnosis, and treatment efforts. In September 2016, a panel of experts from a range of fields presented the Cancer Moonshot Blue Ribbon Report 2016, consisting of ten recommendations for “making a decade’s worth of cancer research progress in five years and to bring the most promising science and clinical developments to all cancer patients in the near term.” The document's authors identified a series of policy issues that are essential to the long-term impact of the project but are outside the scope of the report, including barriers to data sharing.

Members of the advisory panel’s Enhanced Data Sharing Working Group came together after the report’s publication to produce twelve policy recommendations for data sharing in the United States. The Working Group includes several members of the task team are active members of the Global Alliance for Genomics and Health (GA4GH), and the guidance is now published on the GA4GH website as an example of forward looking national approach to data sharing for the US and international research communities.

The guidance builds on the Blue Ribbon Report’s recommendation to: “Create a National Cancer Data Ecosystem to collect, share, and interconnect a broad array of large datasets so that researchers, clinicians, and patients will be able to both contribute and analyze data, facilitating discovery that will ultimately improve patient care and outcomes.” The guidance distinguishes between recommendations that can be immediately implemented by the NCI, addressed in NIH policy, or require legislative action.

The first set of recommendations address motivational approaches to data sharing. Current guidance under the US HIPAA Privacy Rule focuses on de-identification. But with identifiability on a continuum, data governance should also consider the  proposed use and the level of trust in data users. The Working Group recommendations consider the entire research lifecycle. There is a need to (i) motivate patients to engage throughout the research life cycle, (ii) motivate researchers to provide early wide data availability, (iii) restructure NIH funding opportunities in order to meaningfully promote data and tool sharing in a meaningful way, (iv) motivate insurers and clinical labs to make test results widely available, and (v) facilitate IRBs to support enhanced data sharing.

The remaining recommendations address practical mechanisms for data sharing, including (i) harmonizing licensing agreements, (ii) articulating clear privacy guidelines to determine what data can be shared, and (iii) providing a common data schema/ontology in order to enable more efficient and informative analyses.

The recommendations effectively demonstrate how to translate international data sharing principles into a national strategy to improve cancer research and care. The full guidance can be found here.