- In response to a Patient-Centered Outcomes Research Institute (PCORI) request on its Data Access and Data Sharing Policy, the American Medical Informatics Association voiced general support for the guidelines while seeking four changes to the final version. Similar efforts are being made at the National Institutes of Health.
“Data access and sharing is foundational to advance scientific discovery,” said AMIA President and CEO Douglas B. Fridsma, MD, PhD, FACP, FACMI. “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.”
The nonprofit organization has the goal of funding and promoting research that leads to improvements to quality of care and patient outcomes. The data access and sharing policy is one example of its work to advance biomedical and clinical research. At the close of last year, PCORI published a request for comment on its data access and data sharing policy.
In the letter, AMIA letter recommends four items for PCORI to consider when finalizing its policy for accessing and share data.
First, AMIA advises PCORI to require a data sharing plan as part of award applications.
“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,” the letter states.
“Requiring a pre-award description of intended data sharing of federally-funded research could address fundamental deficiencies in biomedical and clinical research,” the letter continues. “We commend PCORI for requiring a data sharing plan post-award, but we believe PCORI could play a leading role in helping improve the data sharing stance of clinical research by asking investigators to think about data sharing in the earliest stages of design.”
AMIA is calling on PCORI to add specific language to it requirements for awardees.
Second, AMIA counsels PCORI to make funding available specifically for data preparation and curation. AMIA anticipates PCORI’s policy will optimize data aggregation in the organizations funded research projects.
“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. This would further underscore the need for quality data sharing plans to be considered as part of the application process,” the letter reads.
Third, AMIA suggests PCORI also define metadata, including requisite attributes and vocabularies useful in providing attributes that “are essential to understanding all data sets.” AMIA also advises PCORI to encourage the use of new community metadata models and ensure data generators receive due credit for their contributions.
Lastly, AMIA recommends PCORI finds ways to ensure that data originators receive credit for their work in the process of biomedical and clinical research.
PCORI will review comments from respondents to the draft policy and combine this feedback with insight gained through its pilot project collaborating with research awardees with certain data repositories in order to formulate a decisive, thoughtful approach to optimizing health data sharing.
In November of last year, AMIA similarly made recommendations for healthcare research improvement during a multi-agency workshop at NIH, suggesting organizations adopt modular and substitutable health IT standards to bolster lab data interoperability. Cost, complexity, and quality standards were the primary considerations organizations needed to make in incorporating these recommendations.