Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
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3 Data-Sharing Platforms
3 Data-Sharing Platforms
Pages 21-34
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while much of the clinical trial data sharing thus far has been carried out by industry. (Rockhold)
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• To conduct a study across multiple clinical trials that are housed in different data-sharing platforms, researchers often must submit multiple separate data requests, conduct parallel analyses in the different platforms, and then attempt to com bine the results. (Shaunessy)
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consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk (IOM, 2015) was used as a blueprint in the development of the Vivli platform, Li said.
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Another challenge is the heterogeneity of data formats. Li added that data supply and demand are not balanced, and Vivli is working to increase awareness of this rich data resource and to raise the number of users.
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links to the Clinical Study Report Summary, the ClinicalTrials.gov trial record, the primary citation, study data specifications, and the annotated case report form. When secondary data users identify a trial of interest, Ross explained, they must apply for access to the data, while listing all investigators and their affiliations and funding and including a narrative summary, a public abstract, and a detailed proposal for the intended research.
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The data generator partner's due diligence includes assessment of the appropriateness of the requested data for the proposed research, and also considers whether patient privacy will be protected and if similar research studies have used the same data being requested. After the data request is approved and the DUA is signed, the investigators can access the data on a secure platform via a virtual private network, which Ross said protects patient privacy and helps prevent further distribution of the data.
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SOURCE: As presented by Joseph Ross, November 18, 2019.
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. With regard to concerns about potential unintended consequences, Ross said that "replication studies have supported, not undermined, the original study, there have been no instances of patient privacy breaches, no publications of spurious safety findings that received unwarranted attention or disrupted patient care, and no data have been used for commercial or litigious purposes." Ross highlighted several areas where attention is needed to better reap the rewards of data sharing.
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r The SOAR Model Although SOAR also serves as an independent review panel for clinical trial datasets being shared by industry, specifically Bristol-Myers Squibb (BMS) , it contains additional components that make it different from other platforms.
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. 7 A project of the Clinical Trials Transformation Initiative to improve public access to a ggregate data in ClinicalTrials.gov.
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. With a better understanding of each other's perspective, data generators might collect and steward data in a way that better facilitates sharing, and data users might be able to propose secondary analyses that make the best use of the available data.
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.11 Challenges and Solutions Establishing a Truly Independent IRP An early challenge, Shaunessy said, was that the IRP was not seen as truly independent because CSDR and the sponsor companies selected the IRP. To remedy this, Wellcome Trust was approached in 2015 about serving as the secretariat for the IRP (as discussed by Kochhar in Chapter 2)
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Another challenge raised by Colin Baigent, deputy director of the Clinical Trial Service and Epidemiological Studies Units at Oxford University, is that data-sharing platforms, in their current form, do not readily enable sophisticated statistical meta-analysis, which requires holding a local copy of the data from multiple trials and sponsors. Therefore, his approach has been to try to obtain data directly from the originator (i.e., keep a local copy of the data with which to work)
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