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

Displaying 46 - 50 of 320 comments
  • Jim Dupree
    University of Michigan
    Role(s):
    • Researcher
    • Clinician
    Date Submitted: Saturday, April 16, 2016 - 18:50

    Requirement To Share Data
    Comments: While such sharing sounds good in principle, it may have a chilling effect on participant enrollment in trials, especially in small scale studies. The assumption that the public always wants transparency runs counter to the logic proposed in the recent U.S. Notice of Proposed Rule Making regarding the Common Rule that people want more complete autonomy regarding their samples and information. Deidentified data is one thing in a multi-site trial enrolling thousands of people. It’s very different in a single site trial that aims to enroll 20 people with a special condition. Participants could well fear that insurance companies, for example, would mine trials in certain zip codes to change rates they’re charging. GINA does not offer protection for things like that. Without serious research to validate that enrollments will not be harmed, this policy could hurt, rather than promote, scientific discovery. In order to allow such research to be carried out, a slowly phased in approach would be more appropriate.

    6 Month Time Frame
    Comments: The six month timeframe is inadequate for sharing deidentified individual patient data. Some analyses may be completed and prepared for publication before other analyses may have even begun. Imposing a short deadline like this may appear to try to encourage more rapid dissemination of results, but it may have the reverse effect, whereby authors will hesitate to publish any results until all the related analyses have been completed, so that this timeframe doesn’t impinge on their own or collaborators’ ability to get the full benefit of their years of research. Either lengthening the standard timeframe to two years, or correlating the timeframe in some fashion to the length of the trial and the size or complexity of the data sets would be more appropriate.

    Require a Data Sharing Plan
    Comments: The inclusion of data sharing plans as part of clinical trial registration sounds reasonable. However, few models for such plans exist. Even in the NIH’s currently proposed protocol templates data sharing section pp. 45, 46, there is no actual data sharing model provided. Only after ICMJE or other authorities can draft a reasonable number of model plans that are easily understandable, easily followed, and appropriately tailored to a variety of research and data types, complete with the metadata criteria that would be needed, will it be appropriate to require such public exposure.

    Providing Credit
    Comments: One option would be to mention the authors by name in an acknowledgment section. Additionally, those reusing the data should pay the original research team for the data, to help subside the research and the financial burdens association with this public reporting and sharing of the research data.

    Other Comments: This policy has been created by a few with little if any budgetary responsibility for the costs of its implementation. At a minimum, sunset provisions for data availability/ maintenance are needed to avoid an ever increasing tax. Researchers, universities, and libraries all need to be able to cull their collections periodically. A standard minimum for data availability (10 years?) may work for those that have centralized resources, but even such an approach ignores differential costs when data is collected via specialized equipment with its own formats, situations where data isn’t all centrally curated, or data storage technology becomes obsolete etc. The costs this imposes on research need to be measured and weighed. The one year timeline from proposal announcement to implementation based on trial enrollment start date is inadequate. Studies that have IRB approval but are not yet enrolling when the policy applies would have to amend their consents, clogging the IRB system unnecessarily. Researchers and IRBs will struggle with developing informed consents adequate to explain data sharing plans. Developing appropriate templates will take significant effort. The policy should be written to apply only to trials that are granted IRB approval 2 years after any policy is announced.

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  • Maha Hussain
    University of Michigan
    Role(s):
    • Clinician
    • Clinical trialist
    Date Submitted: Saturday, April 16, 2016 - 18:19

    Requirement To Share Data
    Comments: Do not agree with the ICMJE proposal

    6 Month Time Frame
    Comments: Do not agree.

    Require a Data Sharing Plan
    Comments: Do not agree

    Providing Credit

    Position:
    Comments:
  • Benjamin Haibe-Kains
    University Health Network
    Role(s): Researcher
    Date Submitted: Saturday, April 16, 2016 - 15:33

    Requirement To Share Data
    • I agree with this general approach
    Comments: Not only data, but also analysis code should be properly documented and shared. It will enable easier verification that the analysis results are fully replicable and that the data have been shared adequately.

    6 Month Time Frame
    Comments: The data should be made available prior to publication if required by the funding agency or upon publication otherwise. Absence of data at the time of publication will prevent the community from reproducing the results, scrutinizing the analysis and performing meta-analyses, which is not acceptable.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: Clinical trial without data sharing policy clearly described during its design and at teh time of registration should not be published. Data sharing plans are key and should not be made more restrictive over the course of a trial.

    Providing Credit
    Comments: As correctly stated, collaboration is not always be possible, practical or desired. Therefore, collaboration and subsequent co-authorship should not be mandatory. Citation of the original publication, use of DOI and detailed acknowledgements already constitutes solid form of credits.

    Other Comments: I strongly suggest (medical) journals to designate a reviewer dedicated to the review of data and code. This is a time consuming process that requires specific (mostly computational) skills, which is usually not performed in depth by the Editor or the Reviewers. This will be crucial to ensure that the new data sharing policies are properly followed.

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  • Ken Woodside
    University of Michigan
    Role(s):
    • Researcher
    • Clinician
    • Clinical trialist
    Date Submitted: Saturday, April 16, 2016 - 08:15

    Requirement To Share Data
    Comments: I think this proposal will cause many US IRBs to deny permission for small and medium sized prospective and retrospective studies to be published in ICMJE journals. I would recommend against this as a requirement. It may be more reasonable to require authors to be willing to share with the editors of the journal for review by the journal's statistician. Furthermore, any request for data from an institution should be cleared by the institution (business agreement for HIPPA protection) and the institution's IRB (effort that should be the requestor's, since this can be involved), as it is difficult to predict what "reverse engineering" of a given deidentification process may be available in the future.

    6 Month Time Frame

    Require a Data Sharing Plan

    Providing Credit
    Comments: Any request for data from an institution should be cleared by the institution (business agreement for HIPPA protection) and the institution's IRB (effort that should be the requestor's, since this can be involved), as it is difficult to predict what "reverse engineering" of a given deidentification process may be available in the future.

    Other Comments: This proposal is fraught with the potential to severely limit the ability of institutions to do research, as the proposal does not exist in a vaccuum, and will have to deal with governments, public backlash, etc.

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    Comments:
  • Chieko Kurihara
    National Institute of Radiological Sciences
    Role(s): Other
      • bioethics researcher
    Date Submitted: Saturday, April 16, 2016 - 04:57

    Requirement To Share Data
    • I agree with this general approach
    Comments: It is extremely important statement and related community should promote this initiative.

    6 Month Time Frame
    • I agree with this general approach
    Comments: Basically we agree with this approach, however, actually it seems to be difficult for all the related investigators to follow this timeline. All the related community should make maximam effots to follow this timeline, and then should voice when they want to extend the deadline, if necessary.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: It is the most convenient solution to proceed with this initiative.

    Providing Credit
    • I agree with this general approach
    Comments: It is a mater of course the author of a publication of original clinical trial is credited in the secondary analysis paper, therefore, we are not sure whether specific alternative means of credit is necessary to be developed. However, if there is any idea to make these procedures more convenient and fruently, we welcome it and it should be great achievement.

    Other Comments: There is a statement that "Sharing clinical trial data, including deidentified IPD, requires planning to ensure appropriate ethics committee or institutional review board approval and the informed consent of study participants". However, Declaration of Helsinki or many of the regulations of human subject protection in the world does not cover resaerch which uses only "deidentified" IPD. An investigator of an original clinical trial project will submit their protocol including clinical trial data sharing plan to ethics committee but researcher of secondary analysis using shared data may not submit their plan to ethics committee. If ICMJE promote (1) Researcher of an original clinical trial should include data sharing plan, as well as informed consent document including data sharing plan, in the protocol submitted to ethics committee ; and (2) researcher of secondary analysis should submit their protocol to ethics committ, including information disclosure to provide a patient an opportunity to refuse it, ICMJE should explicitely state it, and we will agree with this concept.

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