Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
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9 Looking Forward: Incentivizing Data Sharing and Reuse
9 Looking Forward: Incentivizing Data Sharing and Reuse
Pages 101-122
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From page 101... ...
• Data professionals -- including data stewards, curators, librar ians, archivists, and others -- are part of the infrastructure that needs to be built up and better leveraged for clinical trial data sharing. (Nurnberger)
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From page 102... ...
, discussed the roles and relationships of institutions and other clinical research stakeholders in sharing trial data, and the value of engaging libraries in data management activities. Georgina Humphreys, clinical data sharing manager at Wellcome Trust, discussed Wellcome's broad approach to maximizing the value of research data and how open sharing of clinical trial IPD can lead to direct impacts on patient care.
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From page 103... ...
Policies for which data are shared and when vary across clinical trial sponsors, and it can be chal lenging for researchers to know when data might be available for analysis. Roberts observed, for example, that some will share Phase 1 trial data, while others are less comfortable in doing so.
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From page 104... ...
Looking Forward A host of incremental improvements can be made to enhance clinical trial data sharing, such as reducing the cycle times for completing datasharing requests, Roberts said. But she believed it is time to focus on a paradigm shift in the environment.
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Population Health Research Unit. Societal Value of Sharing Clinical Trial Data A variety of different analyses can be conducted using randomized controlled trial data, and Baigent mapped them according to their relative societal value (see Figure 9-1)
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From page 106... ...
This long-term database is maintained by the CTSU at Oxford, and Baigent emphasized the need to preserve such databases independent of the potential uncertainties of data-sharing platforms. He then discussed several of the ways that IPD meta-analysis of shared trial data can provide increased value.
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From page 107... ...
The example Baigent described showed the protective effects of lowering LDL cholesterol in individuals with different baseline LDL cholesterol levels. The IPD meta-analysis found that participants still experienced the protective benefit of lowering their LDL cholesterol levels with statin treatments regardless of their levels at the start of the trial.
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From page 108... ...
Potential Next Steps These examples demonstrate how IPD meta-analysis is a high-value use of shared randomized controlled trial data and "can provide enormously important data to help manage patients," Baigent concluded. However, data-sharing platforms are not ideally suited for IPD meta- analysis when multiple sponsors are involved.
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From page 109... ...
for use, … for every person there is information they are looking to use, for every piece of information there is a potential user, … save the time of the user, … the library is a growing organism." Realizing the Value of Data Sharing Nurnberger asserted that the value of data sharing is worth the cost but said there is "infrastructure debt" to be addressed to fully realize that value. First, as has been discussed, Nurnberger said that clinical trial data need to be FAIR.
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From page 110... ...
Data professionals -- including data stewards, curators, librarians, archivists, and others -- are part of the infrastructure that needs to be built up and better leveraged for clinical trial data sharing. She mentioned the EDISON project of the European Commission, which is working to build the data profession.8 Responsibility for Data Sharing Nurnberger diagrammed the complex "constellation of responsibilities" for data sharing.
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From page 111... ...
She noted that investigators often spend time on data management activities for their projects, which should be handled by data managers, and she called on funders and institutions to support data managers for research teams. She also called on researchers to make their support for technology and library initiatives known to their institutional administration.
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. 10 Nurnberger stated that her adaptation of the CARE Principles to clinical trial data sharing was done with the permission of the indigenous data sovereignty community.
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However, one single activity will not overcome the challenges of sharing clinical trial 12 See https://www.wwarn.org/working-together/study-groups/dp-dose-impact-study group (accessed February 10, 2020)
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From page 114... ...
• More input is needed from the data generators' institutions, said Humphreys. Secondary data users discussed the challenges of DUAs and other legal hurdles to successful data requests, and Humphreys suggested that institutions are not always included in discussions of these issues.
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From page 115... ...
• Learn from the clinical trial registry experience, concluded H umphreys, with regard to driving information sharing forward and creating a paradigm shift. DISCUSSION Access to IPD for Meta-Analyses via Platform or Directly Waldstreicher shared that many research proposals do not require maintaining data locally and can be performed within a secure platform environment.
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From page 116... ...
Baigent summarized that there is broad agreement that data from randomized controlled clinical trials should be shared. The pooled clinical trial data supporting an IPD meta-analysis, however, is often not suitable for sharing, as the data sharing agreement (DSA)
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He asked whether organizations conducting clinical trials should be establishing positions for specialists in data sharing. Roberts said that in her company of about 7,500 employees, several staff members specialize in data sharing.
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Collaboration and collective interpretation by researchers with very different perspectives can also lead to better science, he said. Nurnberger proposed a fourth model, in which clinical trial data are used by others outside of the clinical trial community, in particular, for machine learning or applications of artificial intelligence.
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From page 119... ...
The importance of learning from failure was also raised; sharing data from failed studies is important, she said, so that researchers across companies and sectors can work together. Waldstreicher reiterated the point by Deborah Zarin that the possibility of auditing trials could help "raise the bar" and inspire researchers to collect data in a fashion that better facilitates sharing.
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From page 120... ...
An additional category of data use, Drazen added, includes the application of shared data to examine the result of placebo treatment for people with a particular condition. This application might use shared data to help power a trial (e.g., to determine the frequency of a given complication when no treatment is administered)
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From page 121... ...
Drazen suggested they might require data sharing for large-scale clinical trials, while encouraging data sharing for trials to understand the biology of a disease. Underlying all types of trials, Drazen reiterated, is the need to adopt standards that better facilitate the sharing and use of datasets.
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