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

Displaying 306 - 310 of 320 comments
  • Courtney Peterson
    Pennington Biomedical Research Center
    Role(s):
    • Researcher
    • Clinical trialist
    Date Submitted: Thursday, January 21, 2016 - 15:22

    Requirement To Share Data
    Comments: I am not sure what I think.

    6 Month Time Frame
    Comments: I disagree with the 6-month timeline. If follow-up analysis is being done using that data for another paper, I think authors should have 1 year from the date of publication of the LAST manuscript they plan on producing with the data. For many of our R01 clinical studies, we are writing up papers on that date for 2 years after the study completes and it would not be fair to be scoped by other researchers who are using our own da

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: I think this is a better approach.

    Providing Credit
    • I agree with this general approach
    Comments: Authors should be promised co-authorship if they prefer it and the acknowlegements section needs to dictate what level of involvement the collectors of data played in the new manuscript by others using their data.

    Position:
    Comments:
  • Adam Chekroud
    Yale University
    Role(s):
    • Researcher
    • Clinical trial participant
    • Patient
    Date Submitted: Thursday, January 21, 2016 - 13:19

    Requirement To Share Data
    • I agree with this general approach
    Comments: I wholeheartedly endorse this message.

    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

    Other Comments: Aside from the likely immediate consequences of this (e.g. reanalysis of clinical trial data becoming a routine exercise for graduate level classes), a culture of proactive data sharing and collaborative secondary analysis has the potential to drastically improve the potential benefits of any trial. In addition, there will be likely advances in "precision medicine" approaches that critically depend on the aggregation of larger, mega-analytic datasets that are more amenable to machine learning.

    Position:
    Comments:
  • Michael Jensen
    Mayo Clinic
    Role(s):
    • Researcher
    • Clinician
    • Clinical trialist
    Date Submitted: Thursday, January 21, 2016 - 12:35

    Requirement To Share Data
    Comments: Great - another burden for investigators who already spend too much time doing paperwork. How to set up what data is collected vs. what is able to be included in the paper is an issue. Some of the ancillary data may be needed for investigators for additional manuscripts or grant submissions. I see this as adding another unfunded mandate that will take more time away from investigators and/or their staff to do their jobs. I suggest that if investigators are required to do this a mechanism to reimburse for the time and effort be put in place.

    6 Month Time Frame

    Require a Data Sharing Plan
    Comments: Not possible in today's environment where there are no funds included for this kind of activity. Industry and government are not providing the funding/resources to take on such a significant undertaking. I suggest those writing these guidelines and editorials try running some clinical trials on the funds they are allocated and see if they have money left over to do this additional work

    Providing Credit

    Position:
    Comments:
  • Ann Harvey
    Contra Costa Regional Medical Center and Clinics
    Role(s):
    • Clinician
    • Patient
    Date Submitted: Thursday, January 21, 2016 - 11:28

    Requirement To Share Data
    • I agree with this general approach
    Comments: Wonderful! We need reliable, trustworthy data.

    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

    Position:
    Comments:
  • Frederico Toledo
    Univ. Pittsburgh
    Role(s): Researcher
    Date Submitted: Thursday, January 21, 2016 - 11:16

    Requirement To Share Data
    Comments: The proposal is shortsighted. It is a very unfair. It does not consider the impact on the principal investigators and the academic researcher community. University researchers devote a lot of time and effort, years of their lives, to run clinical trials that generate a stream of publications in subsequent years. This proposal will essentially takes away from investigators the incentives to run trials as the data can be used by others before the investigators can fully publish every possible analysis of their data. Why would an investigator run a complex clinical trial, knowing that someone sitting in an office overseas could use the data to publish articles for a tiny fraction of the time and effort originally spent by the investigators of the trial? Investigators in Academia could seriously consider career changes since academic promotion depends on their publication stream record. This policy might work for Industry-sponsored trials, whose primary interests differ from academic researchers. This new policy could have devastating unintended consequences in the research community. Also, it unduly increases the administrative burden on investigators. Finally, this policy does not stimulate reproducibility in Science. Quite the contrary, it will diverge attention to using old data again and again.

    6 Month Time Frame
    Comments: Disagree.

    Require a Data Sharing Plan
    Comments: Disagree. There is already too much administrative burden being imposed on academic researchers, who typically operate under constrained budget situations in the US.

    Providing Credit
    Comments: There is no viable way to give that credit. And what if the original investigators disagree with the findings. There are also huge conflicts of interest created by this policy. This policy well intentioned in spirit, but very misguided. It will bring unintended consequences to the research world.

    Other Comments: The proposal could very well unintended consequences in the academic research community. It has too many flaws.

    Position:
    Comments:

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