Sharing Clinical Trial Data Maximizing Benefits, Minimizing Risk (2015) / Chapter Skim
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6 The Future of Data Sharing in a Changing Landscape
6 The Future of Data Sharing in a Changing Landscape
Pages 163-178
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From page 163... ...
More public discussions about how best to address the challenges of data sharing will be needed, ideally informed by the ongoing experience of data sharing initiatives. To help guide such discussion, the committee articulates its vision for the future: • There are more platforms for sharing clinical trial data, with dif ferent data access models and sufficient total capacity to meet demand.
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From page 164... ...
• Best practices for sharing clinical trial data are identified and modi fied in response to ongoing experience and feedback. The sharing of clinical trial data forms a "learning" ecosystem in which data on data sharing outcomes are routinely collected and continually used to improve how data sharing is conducted.
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From page 165... ...
The requester then can view and analyze the data but cannot download a copy of the data to his/her own machine. Variants of this model currently exist for sharing clinical trial data (e.g., Yale University Open Data Access [YODA]
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From page 166... ...
However, a large federated system could coexist with multiple trusted intermediaries purchasing query services from multiple providers. A federated query approach can support access control models in which data requesters are able to query multiple databases simultaneously while data holders maintain control of their own data at all times.
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From page 167... ...
Data are usable only if an investigator can search and retrieve them, can make sense of them, and can analyze them within a single trial or combine them across multiple trials. Given the large volume of data anticipated from the sharing of clinical trial data, the data must be in a computable form amenable to automated methods of search, analysis, and visualization.
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From page 168... ...
Workforce Challenges An adequate workforce trained in the operational and technical aspects of data sharing is essential to meet the goals of responsible sharing of clinical trial data. As outlined in the 2012 report of the Advisory Committee to the NIH Director, there is a growing gap between the supply
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From page 169... ...
CTSA institutions could provide technical support and an infrastructure for sharing clinical trial data and also develop and disseminate best practices for data sharing among the CTSA consortium and partner institutions. As the academic homes for advancing innovative clinical and translational research, the leaders of National Center for Advancing Translational Sciences (NCATS)
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From page 170... ...
The committee notes that responding to que ries from potential secondary users is a challenge because staff that worked on a clinical trial are assigned to new projects after the trial's completion or leave the sponsor, data coordinating center, or institution that carried out the study. Responding to such queries is an important aspect of responsible sharing of clinical trial data: If there is no one to answer questions about the data from secondary users, the scientific usefulness of the shared data will be compro mised.
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From page 171... ...
Public funders of clinical research such as NIH, whose budget has been declining in real dollars, may be reluctant to fund the sharing of clinical trial data if doing so would further reduce the funds available for new research grants. Finally, from a global perspective, the committee notes that the costs of data sharing may be prohibitive for clinical trialists in low-resource countries.
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From page 172... ...
Additional sources of funding for responsible sharing of clinical trial data may be identified; for example, private philanthropies may be interested in funding the development of infrastructure and the conduct of pilot projects for responsible sharing of clinical trial data or subsidizing data access in resource-poor countries. Third, policies on equitably sharing the costs of responsible sharing of clinical trial data among stakeholders should be based on accurate information on the costs of data sharing for various kinds of clinical trials.
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From page 173... ...
Structure for Collaborative next steps Sharing clinical trial data is a global health priority that is gathering momentum. The commissioning of the present study was intended to further the dialogue and begin to build a stronger foundation for a robust data sharing culture.
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From page 174... ...
that organizations sharing clinical trial data "learn from experience by collecting data on the outcomes of data sharing policies, procedures, and technical approaches (including the benefits, risks, and costs) , and share information and lessons learned with clinical trial sponsors, the public, and other organizations sharing clinical trial data." In this chapter, the committee has further developed the idea of improving the sharing of clinical trial data by drawing on experience in other areas of biomedical research and health care.
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From page 175... ...
In Chapter 3, the committee recommends that disease advocacy organizations, regulatory and research oversight agencies, Institutional Review Boards or Research Ethics Committees, research institutions and universities, medical journals, and membership and professional societies take certain steps to promote responsible sharing of clinical trial data. Many challenges will best be addressed through collaborative efforts involving different types of institutions.
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From page 176... ...
Because responsible sharing of clinical trial data is so multifaceted, people working on one aspect of data sharing need to be aware of how their work interacts with work on other aspects. The committee recommends that a combination of public, nonprofit, and industry funders, similar to the sponsors of this project, take the lead in convening these stakeholders.
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From page 177... ...
2014. Strategies and practical approaches for responsible sharing of clinical trial data: Perspec tives of trial sponsors and investors.
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From page 178... ...
2014. Clinical trial data sharing from the pre-revenue biotech perspective: Addressing the impact of limited resources on the implementation of data sharing technologies.
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