Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
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6 Infrastructure Sustainability
6 Infrastructure Sustainability
Pages 61-74
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From page 61... ...
(Humphreys) • Wellcome Trust funding awards will cover the cost of shar ing data, but applicants often do not include a data outputs management plan or a specific cost estimate for curation and sharing in their funding request.
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1 supporting research every year and, Humphreys said, intends that the outputs of that research "be accessed and used in ways that maximize benefit to health and society." She described Wellcome as "a passionate champion and advocate of open access and data sharing … driven by long-standing policies." Researcher Challenges Humphreys shared findings from the Springer Nature survey Practical Challenges for Researchers in Data Sharing. She noted that this was a cross-disciplinary survey of more than 7,700 researchers and was not specific clinical research, but the findings are similar to results from a survey of clinical trial researchers that Wellcome and other funders recently conducted.
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One option Humphreys described is to permanently embed data stewards in institutions that sponsor clinical trials to support all of the necessary data-sharing activities at the institution. This would help FIGURE 6-1 Costs of sharing.
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Another issue to be addressed is the lack of minimum agreed data standards. Humphreys pointed out that there are standards for pharmaceutical companies that will submit data for product licensure, but there is not yet any agreement on data standards among academic researchers.
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Humphreys concluded that designing trials with sharing in mind, including adhering to data standards prospectively, could help to reduce the costs of preparing clinical trial data for sharing. INDUSTRY PERSPECTIVE Pandurang Kulkarni, Chief Analytics Officer and Vice President of Biometrics and Advanced Analytics, Eli Lilly and Company Kulkarni shared how he gained an appreciation for the complexity of clinical trials after moving from academia to industry.
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The company fully supports investing in data sharing, and he clarified that his 6 Further information on SDTM and ADaM are available in the FDA Data Standards Catalog. See https://www.fda.gov/industry/fda-resources-data-standards/study-datastandards-resources (accessed February 10, 2020)
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Commitment to Data Sharing Lilly is committed to sharing clinical trial data, and Kulkarni said that data sharing "is part of the normal process of conducting clinical rials for Lilly." In addition to listing trials on the Vivli platform, Lilly t also participates in Project Data Sphere and the TransCelerate Placebo and Standard of Care Data Sharing initiative.7 The latter has allowed Lilly to use shared control arm data to inform trial design and, in some cases, 7 See https://transceleratebiopharmainc.com/initiatives/placebo-standard-of-care (ac cessed February 10, 2020)
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He expressed concern that if shared data are not being accessed and used, interest by data generators in supporting the infrastructure for sharing could wane. PLATFORM PERSPECTIVE Sean Coady, Program Officer, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute Coady discussed data-sharing infrastructure sustainability challenges from the perspective of an individual NIH institute.
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sequences and other omics data.10 In 2019, the institute began development of BioData Catalyst, a cloud-based infrastructure for data and tools built on a data commons approach to sharing and data science.11 Challenges Coady highlighted several concerns in the areas of platform usability, resource constraints, and outcome metrics, pointing out that his perspective on the challenges facing platforms is similar to those expressed by other workshop panelists. Usability and Resource Constraints Coady showed a graph of the cumulative data access requests for both clinical trial and observational data in the NHLBI registry, which illustrates the increasing rate of demand, especially for clinical trial data (see Figure 6-2)
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Coady described the NHLBI data repository as a "come as you are" repository of clinical trials and observa tional studies and said that the lack of standards for metadata impacts data discovery and usability, especially as the repository expands. • Stewardship burden.
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Humphreys agreed that the lack of standards is a priority item and suggested that there is a need for an internationally recognized body to convene stakeholders and drive the standard-setting process. Amy urnberger referred thers to the Research Data Alliance, which N o has convened working groups to consider standards, including metadata standards, for specific fields, including health (although not specific to clinical trials)
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Alex Sherman added that, years ago working with the Critical Path Institute, they calculated the costs of the activities needed to merge data from multiple trials in the same disease space to be $25,000 to $30,000. Costs of Providing IPD to Participants A workshop participant said that clinical trial participants generally have the right to their own patient-specific data from trials and asked how frequently such requests are made and what the costs of fulfilling the
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Kulkarni responded that the trial sponsor is never in direct contact with participants, and that it would be a trial investigator who receives and fulfills the request from the patient. Sherman said that clinical research organizations routinely deliver trial participant data to each site, and the cost of providing an individual's clinical trial data would be essentially the same as that for other participants at the same site.
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