Reflections on Sharing Clinical Trial Data Challenges and a Way Forward: Proceedings of a Workshop (2020) / Chapter Skim
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4 Striking a Balance Between Benefit/Value and Risk/Cost
4 Striking a Balance Between Benefit/Value and Risk/Cost
Pages 35-46
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From page 35... ...
(Drazen) • The new generation of medical practitioners has expertise in data science and can readily use shared clinical trial data to help identify novel findings.
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From page 36... ...
DATA ANALYST PERSPECTIVE David DeMets, Professor Emeritus, Department of Biostatistics and Biomedical Informatics, University of Wisconsin DeMets shared four case examples of the value that can be derived from secondary analysis of shared data, three of which demonstrate how data sharing can uncover issues and provide lessons (e.g., elucidate the impact of methodology on interpretation, identify errors or fraud) , and a fourth that led to new insights and additional publications and collaborations.
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From page 37... ...
Duke University researchers Anil Potti and Joseph Nevins published s everal high-profile papers describing genomic predictors of cancer risk and therapeutic response, and these genomic predictors were subsequently used in Duke clinical trials. However, statisticians at MD A nderson were unable to reproduce the Duke researchers' results.
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From page 38... ...
Reflections on the Benefits and Costs of Data Sharing Speaking from his perspective as a data analyst, DeMets reflected on the potential benefits and costs associated with data sharing. Archiving a complete clinical trial data file in a form and level of detail sufficient for 3 See https://clinicaltrials.gov/ct2/show/NCT00180258 (accessed March 2, 2020)
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From page 39... ...
Drazen, New England Journal of Medicine Group Editor Drazen discussed some of the concerns about data sharing and secondary analysis raised by three key stakeholder groups: clinical trialists, participants, and data scientists; he further presented the SPRINT Data Analysis Challenge as an example of how clinical trial data can be used to identify new findings of medical importance. He also took the opportunity to respond to the comment by DeMets (see above)
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From page 40... ...
Importantly, secondary analysis of shared data by data scientists can reveal new information and ideas that can advance human health, he said. SPRINT Data Analysis Challenge Drazen elaborated on SPRINT, introduced by Taylor (see Chapter 2)
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From page 41... ...
He concluded that there are many positive aspects of having many different people analyze clinical trial data, but there are also challenges, such as the cost and effort to facilitate sharing. To encourage both data sharing and secondary analysis, it is important to demonstrate the value that can be obtained, and examples are needed of how secondary analysis has led to behavioral change that impacted health as confirmed by another clinical trial.
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From page 42... ...
Peel mentioned two current examples of sharing of real-world health data. Project Nightingale by Google is collecting patient health data through an agreement with a large health system and without the knowledge of patients or providers.7 Apple is now involved in medical research by, for example, enabling clinical research recruiting through a phone app and using new technologies, such as the Apple Watch that can collect health data, to conduct research in new ways.
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From page 43... ...
Quantitative metrics of the impacts and outputs of data sharing are needed to make the business case for the allocation of resources to support sharing. He said he had searched and found that the publications arising directly from work done by the three SPRINT Data Analysis Challenge winners had been cited only 14 times, which he said did not seem to demonstrate sufficient value for the effort.11 8 Peel referred participants to https://blackbookmarketresearch.newswire.com/news/ healthcares-digital-divide-widens-black-book-consumer-survey-18432252 (accessed February 10, 2020)
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From page 44... ...
Researchers worldwide can access the shared sequence data to inform the development of experimental questions and study design. With this in mind, Drazen suggested that the number of peerreviewed publications associated with shared clinical trial data might not be the ideal metric of the value of clinical trial data sharing.
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Informed Consent for Data Sharing Sherman noted the need for standardized data-sharing practices and standardized legal documents. He said the informed consent form for all clinical trials his institution conducts includes participant consent that their data will be used for any medical research purpose.
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46 REFLECTIONS ON SHARING CLINICAL TRIAL DATA pants consent or decline to share their data. The primary publication would include the full trial population.
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