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The issue of data sharing and integrity extends beyond clinical trials. There is an ongoing debate about the tension between sharing published data and the need to protect the intellectual property that an academic might have spent years developing. Simply limiting data sharing to those in a specific publication is not the answer. In the field of genetics or genomics one might have a data set of over a million genetic variants. The first publication may have arisen as a result of the univariate analysis of all these variables, with typically only a handful of the most significant being reported. Should all the variants be considered as having been published? There are many more analyses that the investigator would still have planned, but if the data were made freely available to others she may lose her competitive advantage despite huge personal investment.
The need for checking on the integrity of data and data analyses in the published literature is a separate issue. One simple solution would be for journals to require that the data on which a paper is published and all the analysis scripts be made available as part of the submission process. Reviewers would sign a simple confidentiality agreement and have access to those data to check the analyses if they wished. When published, other scientists expressing legitimate concerns could also request the data and analysis scripts from the journal and be given access on the same basis.
No competing interests
14 December 2012
Public health doctor
Unversity of Cambridge
Strangeways Research Laboratory, Worts Causeway, Cambridge, CB1 8RN