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

Displaying 56 - 60 of 320 comments
  • Alon Kahana
    University of Michigan
    Role(s):
    • Researcher
    • Clinician
    Date Submitted: Friday, April 15, 2016 - 17:13

    Requirement To Share Data
    Comments: This is a well-intentioned idea that will have an unintended consequence of inhibiting important clinical research. Simply put, the administrative costs associated with compliance would be prohibitive, and many patients will be reluctant to enroll in studies if their information is published - even if deidentified, because many do not trust that the deidentification is real.

    6 Month Time Frame
    Comments: I am not supportive of deidentified individual patient data.

    Require a Data Sharing Plan
    Comments: The overall costs of compliance are prohibitive and will interfere with our ability to conduct important clinical trials.

    Providing Credit
    • I agree with this general approach

    Other Comments: Regulatory requirements have become really prohibitive. I think that it's time to take a step back and realize that many good ideas are just not logical to implement.

    Position:
    Comments:
  • Justine Wu
    University of Michigan
    Role(s): Clinician
    Date Submitted: Friday, April 15, 2016 - 16:59

    Requirement To Share Data
    Comments: While i agree with the ethical and scientific basis for this proposal, I am very concerned about the impact this will have on researchers who work with smaller patient cohorts (e.g., qualitative studies, mixed methods studies) and the utility of data that needs to be stripped down so much to avoid possible identification of subjects.

    6 Month Time Frame
    Comments: I do not believe 6 months is adequate for most trials - furthermore, the time needed will vary by complexity of the trial and analysis. A minimum of 1-2 years should be given based upon ongoing analyses and complexity of the data set.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: A standardized guide/formats (with different versions tailored to type of trial) should be developed prior to making such a requirement

    Providing Credit

    Position:
    Comments:
  • Rajesh Rao
    University of Michigan
    Role(s):
    • Researcher
    • Clinician
    • Clinical trialist
    Date Submitted: Friday, April 15, 2016 - 16:42

    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: Those doing new analyses have to pay for the data, in part to subsidize the cost of the research.

    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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    Comments:
  • Jane Huggins
    University of Michigan
    Role(s): Researcher
    Date Submitted: Friday, April 15, 2016 - 16:26

    Requirement To Share Data
    Comments: I am very concerned that this policy would prevent studies on data recorded prior to the initiation of the policy. IRBs are reluctant to let data be shared if the sharing is not explicitly described in the consent form (and sometimes if the precise purpose of the sharing is not described in the consent form). So, any existing data could not be used for comparison or analysis.

    6 Month Time Frame

    Require a Data Sharing Plan
    Comments: Will the journals host the resources required to share the data? Most labs don't have the resources to host a website for distribution of data. And, if someone changes institutions, who maintains the data for sharing?

    Providing Credit
    • I agree with this general approach

    Position:
    Comments:
  • Dimple Aggarwal
    Helsinn Therapeutics
    Role(s): Researcher
    Date Submitted: Friday, April 15, 2016 - 15:02

    Requirement To Share Data
    Comments: I don't think individual patients data should be shared.

    6 Month Time Frame

    Require a Data Sharing Plan

    Providing Credit

    Position:
    Comments:

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