Requirements for Reporting Industry-Sponsored Studies - AMA Manual of Style

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Requirements for Reporting Industry-Sponsored Studies 

Requirements for Reporting Industry-Sponsored Studies

Ethical and Legal Considerations

Annette Flanagin

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Subscriber: null; date: 26 September 2016

Requirements for Reporting Industry-Sponsored Studies

UPDATE: The requirement for independent statistical analysis in industry-sponsored or industry-analyzed studies published in JAMA has been discontinued. This change was made July 10, 2013.

Biases are potentially introduced when sponsors are directly involved in research.2,5,6,8,10,24 As a result, for industry-sponsored studies, JAMA and the Archives Journals require an access to data statement to be provided by an investigator who is not employed by any funding source with a proprietary interest in the outcome of the study.4 In addition, JAMA will not accept for publication an industry-sponsored study in which the data analysis has been conducted solely by statisticians employed by the company sponsoring the research. For these studies, an additional analysis of the data (entire raw data set, study protocol, and prespecified plan for data analysis) must be conducted by an independent statistician at an academic institution, such as a medical school, academic medical center, or government research institute, that has oversight over the person conducting the analysis who is independent of the commercial sponsor.4 This provides the editor with an authority who does not have financial interest in the findings (eg, the independent statistician’s department chair or dean) to contact if there are concerns about the analysis or any allegations of misconduct that the sponsor cannot or will not address for proprietary reasons. JAMA publishes the results of such analysis, along with the name and academic institution of the independent statistician and whether compensation or funding was received for conducting the analyses, in the Acknowledgment section (see 2.10, Manuscript Preparation, Acknowledgment Section, and 5.2, Acknowledgments).

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