Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
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2 Perspectives on Current Data-Sharing Policies in Practice
2 Perspectives on Current Data-Sharing Policies in Practice
Pages 9-20
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From page 9... ...
• Trial participants do not necessarily perceive any disadvan tage to widely sharing their clinical trial data and generally consider that data sharing is beneficial. (Taylor)
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From page 10... ...
Moses Taylor, Jr., spoke from his personal experience as a clinical trial participant. Sonali Kochhar, medical director of Global Healthcare Consulting, discussed facilitating data sharing from her perspective as a member of an independent review panel.
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that the data they generate are their own, which can impede progress on data sharing. This can occur, he added, despite their acknowledgment of the public good of data sharing and even though data would not exist without trial participants and a broad range of others on the clinical trial team.
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From page 12... ...
PATIENT PERSPECTIVE Moses Taylor, Jr., Participant, Systolic Blood Pressure Intervention Trial Taylor shared his perspective as a clinical trial participant, drawing from his personal experience in the Systolic Blood Pressure Intervention Trial (SPRINT) 4 as well as his interactions with other trial participants during the 2017 Aligning Incentives for Sharing Clinical Trial Data summit.5 The Benefits and Risks of Sharing and Not Sharing Trial Data Other than being asked to consent to sharing of their data, trial participants generally receive little or no information about what will be done with the data generated from a given study, Taylor reported.
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From page 13... ...
From a patient perspective, Taylor said, there is a belief that if more people conduct secondary analysis on data, there is a better chance that discoveries will be made that will help trial participants and others with the same or similar conditions. Sharing data widely can provide "checks and balances," Taylor added, and helps to reduce unintended bias in interpretation as well as misuse of the data by the original trialists versus if data were otherwise not shared.
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From page 14... ...
found that researchers share data primarily through direct contact, such as email. Data-Sharing Platforms Kochhar suggested that data-sharing platforms can help researchers share data by providing "a standard, transparent access route, independent of the data generator." Platforms can also help protect trial participants and align with patient consent by anonymizing data and restricting data access.
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From page 15... ...
In some cases, she said, researchers are approved for access but never log in or conduct analysis. Kochhar noted that a study sponsor has the right to veto secondary data use requests due to concerns, such as potential conflict of interest or competitive risk.
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For example, secondary analysis of data can inform future clinical trial design. Kochhar agreed but added that thus far most secondary data users have been interested in conducting novel research, not designing future clinical research.
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From page 17... ...
Jorgenson highlighted the three main reasons NIH is investing significantly in sharing data from clinical trials: 9 Jorgenson referred participants to the Draft Data Management and Sharing Policy that was recently released by NIH for public comment, available at https://osp.od.nih.gov/ scientific-sharing/nih-data-management-and-sharing-activities-related-to-public-accessand-open-science (accessed February 10, 2020)
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2. Sharing clinical trial data supports the accountability and trans parency of NIH as a public funder of clinical trials.
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From page 19... ...
Challenges and Opportunities One challenge to sharing clinical trial data is meeting the needs of the different stakeholders that NIH serves. Jorgenson pointed out that the level of granularity needed by scientists is different from that needed by the public.
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