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Who owns the data in a clinical trial?

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Abstract

Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both publicly and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication.

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Correspondence to Jeffrey M. Drazen.

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J. M. Drazen is Editor-in-Chief of The New England Journal of Medicine and Professor of Medicine at Harvard Medical School.

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Drazen, J.M. Who owns the data in a clinical trial?. SCI ENG ETHICS 8, 407–411 (2002). https://doi.org/10.1007/s11948-002-0062-x

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  • DOI: https://doi.org/10.1007/s11948-002-0062-x

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