Comments on the ICMJE’s Proposals for Sharing Clinical Trial Data

Displaying 296 - 300 of 320 comments
  • Steven Joffe
    University of Pennsylvania Perelman School of Medicine
    Role(s):
    • Researcher
    • Clinician
    • Other
      • Medical ethicist
    Date Submitted: Friday, January 22, 2016 - 17:57

    Requirement To Share Data
    • I agree with this general approach

    6 Month Time Frame
    • I agree with this general approach

    Require a Data Sharing Plan
    • I agree with this general approach

    Providing Credit
    • I agree with this general approach
    Comments: 1. Suggest working with med school & other deans to define mechanism that investigators can list on their CVs for purposes of promotion, etc. 2. Suggest working with NLM to develop searchable database, and to link identity of data contributors to PubMed entries of secondary publications. 3. Suggest defining who data contributors are? In a big multicenter trial, should hundreds of investigators who contributed data be listed? Just core group of trial leaders? Personally favor relative narrow approach.

    Other Comments: Suggest 2 further additions to policy: 1. ICMJE defines mechanism for sanctioning recipients of data who reidentify study subjects (published list of people who reidentify, expressions of concern/retractions, limitations on ability to request secondary data in the future, etc.). 2. Suggest that, alongside secondary publications, editors develop system to allow original data collectors to comment (presumably online) on the new publication. This will give collectors a forum to express any concerns, disagreements, clarifications, caveats, etc. Opportunity for original collectors to comment, with links to publication, should be universal. Will help prevent abuse of secondary data access.

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  • John
    n/a
    Role(s): Patient
    Date Submitted: Friday, January 22, 2016 - 15:54

    Requirement To Share Data
    • I agree with this general approach

    6 Month Time Frame
    Comments: I think this only invites the same sort of behavior that has prompted the proposal to begin with. Instead of a 6 month timeframe post-publication, the journals could instead require the data as a prerequisite for publication following acceptance. This both speeds up post-publication peer review and also might serve to hinder sensationalized press releases and media coverage since problems might arise at any time following publication.

    Require a Data Sharing Plan
    • I agree with this general approach

    Providing Credit
    Comments: I agree with some, but not all, of this. If you are skeptical of the claims made within a given paper and seek to reanalyze the dataset from a critical standpoint, the original authors might be very reticent about collaborating with you and provide all sorts of roadblocks to the publishing of new analyses. For example, if a group has deviated substantially from a trial protocol and you would like to analyze the data according to the original protocol, this might be met with stiff resistance from the original authors. Another individual has proposed the following suggestion- "Perhaps we need a second tier of citations, “supercitations” if you will, that can only be used in reference to a data paper which forms the basis for a new paper. These supercitations would be counted seperately and individuals could build up a high “super h-index” by publishing useful datasets." - Neuroskeptic (@Neuro_Skeptic) January 22, 2016 at 17:49 https://forbetterscience.wordpress.com/2016/01/22/research-parasitism-and-authorship-rights/comment-page-1/#comment-179

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    Comments:
  • william grant
    SUNY Upstate Medical University
    Role(s): Researcher
    Date Submitted: Friday, January 22, 2016 - 12:51

    Requirement To Share Data

    6 Month Time Frame

    Require a Data Sharing Plan
    Comments: with open data sets how do we stop this kind of data mining? http://slatestarcodex.com/2016/01/20/side-effects-may-include-anything/ And, how do we stop trolls from mining the data sets to publish new papers that may or may not be appropriate to the data set And. they will be able to do that without doing any work

    Providing Credit
    • I agree with this general approach
    Comments: There must be something that protects the original researcher and their efforts Acknowledgment of the source for any other published work? Review rights to any new paper published off the open data set?

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  • william grant
    SUNY Upstate Medical University
    Role(s): Researcher
    Date Submitted: Friday, January 22, 2016 - 12:49

    Requirement To Share Data
    Comments: It is still unclear what studies will constitute 'clinical trials' under the definition proposed. Many resident and fellow trials might fit this definition but do not require ClinicalTrials.gov registration. Does this mean that the expectation is a data release for every intervention with patients? Would this also include quality studies which are IRB exempt?

    6 Month Time Frame

    Require a Data Sharing Plan
    Comments: Will it be acceptable to use FDA or statistical expert review to provide data sets in which some information may be redacted to reduce the possibility of identification of individual subjects? This would be especially critical in small data sets which are from patient groups with limited or unusual diagnoses.

    Providing Credit
    • I agree with this general approach

    Position:
    Comments:
  • Gerard Ridgway
    University of Oxford
    Role(s): Researcher
    Date Submitted: Friday, January 22, 2016 - 09:16

    Requirement To Share Data
    • I agree with this general approach

    6 Month Time Frame
    Comments: Where there has been a data sharing plan in place since the registration of the trial, it seems unnecessary to have a delay of 6 months following publication before data is shared. Data should be carefully checked before submitting a manuscript, not several months after its eventual publication. Such a delay might be helpful during the introduction of this policy, but once trials are routinely planning data sharing from their inception, the delay should be substantially reduced.

    Require a Data Sharing Plan
    • I agree with this general approach

    Providing Credit
    • I agree with this general approach
    Comments: To start with, the ICMJE should ensure that its member journals are willing to include data citations in the bibliographies of articles they publish, and that their editors and reviewers are aware of this, and do not request authors to remove data citations from the bibliography. For example the NEJM's guidance not to cite "unpublished data" [http://www.nejm.org/page/author-center/manuscript-submission] should be clarified to avoid being misunderstood to apply to data-sets that are available and citable but are not associated with a traditional journal article [see https://www.datacite.org/services/cite-your-data.html]. The ICMJE should also work with indexing and bibliometric services (Web of Science, Scopus, Google Scholar, etc.) to ensure that these citations are properly indexed and included in related computations (such as journal impact factor, author h-index, etc.). This might imply that data should be cited in the main manuscript, not only in supplementary material, in which case that should be clear in the information for authors.

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