“As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material)…” (see editorial for further details)

[ X ] I agree with this general approach (check if applicable, and/or provide additional comments below)

The signatories support the sharing of all data underlying any scientific publication, to the broadest level allowed given participant consents. These data provide the basis for the claims made within the publication and should be available as part of the scientific record. In order to maximize the ability to assess the merits of claims made by the authors, data should be made available during the review of the primary article. Having these data available to the entire scientific community post-publication, as is proposed here, is also vitally important. First, release of these data will enable direct assessment of the individual study in order to determine how it advances the field. Second, release of these data will allow researchers maximize the benefit of data donation through aggregation and further analysis.

Proposed 6 month timeframe following publication for sharing deidentified individual patient data (see editorial for further details)

[ O ] I agree with this general approach (check if applicable, and/or provide additional comments below)

The signatories suggest that the ICMJE require that all IPD be made available immediately upon primary publication. Compliance with such requirements is quite low without some sort of formal incentive or deterrent (in this case: publication, or withholding of publication). If ICMJE has strenuous objection to data release at the time of publication, the signatories suggest that the primary data be made available to the public in an embargoed manner. That is, these data are released to journal editors by authors as a requirement at the time of primary publication and are subsequently released more broadly after the decided upon embargo period (e.g. 6 months).

“The ICMJE will also require that authors include a plan for data sharing as a component of clinical trial registration.” (see editorial for further details)

[ X ] I agree with this general approach (check if applicable, and/or provide additional comments below)

<no additional comments>

“…those who generate and then share clinical trial data sets deserve substantial credit for their efforts. Those using data collected by others should seek collaboration with those who collected the data. However, because collaboration will not always be possible, practical or desired, an alternative means of providing appropriate credit needs to be developed and recognized in the academic community. We welcome ideas about how to provide such credit.” (see editorial for further details)

[ O ] I agree that an alternative means of providing credit to those who generate and share clinical trial data sets needs to be developed (check if applicable, and/or provide additional comments and ideas below)

The signatories think it is of paramount importance that data generators receive appropriate credit for their contributions to science - both as primary researchers, as well as for broadly affecting the research ecosystem by the use of their work in a secondary manner - however, we do not believe that novel attribution credits are necessary. Traditional literature citation and, more specifically, digital object identifiers (DOIs) are mechanisms to provide credit to researchers for their contributions to the scientific community. Given the difficulty of gaining traction for new credit mechanisms, the signatories strongly suggest that the ICMJE adopt data citation practices already in use within the broader scientific community, i.e., DOI for data citation as adopted by data journals.

Other Comments

The signatories applaud the ICMJE for taking on this extremely important topic. It is our belief that the broad availability of clinical trial data will both improve the public trust in published trials as well as maximize the long-term impact of the data donated by the research participants who have so unselfishly contributed to these trials.