AMIA Recommends Improvements to PCORI Data Sharing Policy

The American Medical Informatics Association (AMIA) commended, in comments submitted this week, the Patient-Centered Outcomes Research Institute (PCORI) for developing a data access and sharing policy. The organization of biomedical and clinical research informaticians, however, provided a number of recommendations to improve data access and exchange, including that PCORI consider requiring a preliminary data sharing plan as part of award applications, and earmarking specified amounts of grant funding for data preparation and curation.

“In total, AMIA sees this policy as maximizing the utility and usability of data collected in research projects PCORI funds,” the organization stated.

In late 2016, PCORI issued a Request for Comment on its Data Access and Data Sharing Policy, which “set forth expectations and guidelines for PCORI research awardees for management of their data in order to do the following: (1) facilitate reproduction of original analyses to increase the integrity of PCORI-funded research findings; and (2) promote data sharing to enable conduct of additional analyses using data from PCORI-funded studies, thereby augmenting the knowledge generated from the original studies.”

PCORI officials noted similar efforts underway at the National Institutes of Health and said its policy sought to promote the benefits of data sharing, “while being mindful of the numerous practicalities and challenges related to its implementation.” The Request for Comment included specific questions, which AMIA addressed in its comments.

Among the high-priority and overarching recommendations, AMIA said PCORI should consider:

• Requiring preliminary data sharing plans as part of award applications, not just as a post-reward requirement;
• Earmarking specified amounts of grant funding for data preparation and curation, in addition to covering reasonable costs associated with maintaining and depositing the Full Data Package; (including de-identification);
• Defining metadata, including requisite attributes and vocabularies used to provide attributes, as an explicit component of the Analyzable Data Set, and encourage the use of emerging community metadata models; and
• Establish ways to ensure data originators receive credit for their work.

“Data sharing has become such an important proximal output of research that we believe the relative value of a proposed project should include consideration of how its data will be shared,” AMIA said in comments. “Requiring a pre-award description of intended data sharing of federally-funded research could address fundamental deficiencies in biomedical and clinical research.”

In addition, AMIA recommended PCORI include funding for data preparation and curation as part of project budgets. “AMIA fully supports and appreciates PCORI’s intention to provide funding for costs associated with maintaining and depositing the Full Data Package in a suggested repository, as outlined in Section D of the data sharing plan. However, evidence suggests that dedicated funding for data curation and preparation for sharing is an important contributor to the sustainability of research ecosystems. By including data sharing costs in proposed budgets, and by providing guidance regarding best practices, PCORI creates incentives to share, collaborate and advance data sharing capabilities.”

“Data access and sharing is foundational to advance scientific discovery,” AMIA president and CEO Douglas B. Fridsma, MD, PhD, said in a prepared statement. “PCORI’s data access and sharing plan will help ensure that comparative effectiveness research adds to our corpus of evidence-based medicine, while also tearing down the data silos that have come to characterize too many research efforts. We commend PCORI for placing a focus on the need for improved data sharing.”