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

Displaying 301 - 305 of 320 comments
  • Elizabeth Wager
    Sideview, UK / University of Split, Croatia
    Role(s):
    • Researcher
    • Other
      • journal editor
    Date Submitted: Friday, January 22, 2016 - 06:12

    Requirement To Share Data
    • I agree with this general approach

    6 Month Time Frame
    Comments: I am concerned that this makes the guideline costly and hard to enforce. It also reduces the usefulness to readers. While I accept that preparing data for sharing can be time-consuming, I worry that journals will not check whether authors have made the data available within this timeframe. It would be much more effective (although tougher) to require it at the time of publication, since this could easily be checked by the journal.

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

    Providing Credit
    • I agree with this general approach

    Other Comments: The document emphasizes the role of trial registers for sharing data. What about other types of repository. Maybe a quibble, but I don't like the emphasis on the risk for people taking part in clinical trials. In my view, there is an ethical responsibility to publish and to share data from ALL trials, regardless of the risk to participants, and many trials involve no risk (eg public health interventions to reduce fizzy drink consumption or stop smoking, use of bednets to reduce malaria, etc.) It is unethical to waste resources by not making data public that might advance health.

    Position:
    Comments:
  • Kate Dunn
    Keele University
    Role(s): Researcher
    Date Submitted: Friday, January 22, 2016 - 06:07

    Requirement To Share Data
    • I agree with this general approach

    6 Month Time Frame
    • I agree with this general approach
    Comments: Following all planned publications, not following the first or main publication.

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

    Providing Credit
    • I agree with this general approach

    Position:
    Comments:
  • Laura Lehmann MD
    Maple Grove Family Health and Wellness Center, Maple Grove, MN
    Role(s): Clinician
    Date Submitted: Thursday, January 21, 2016 - 20:02

    Requirement To Share Data
    • I agree with this general approach
    Comments: I agree with this approach wholeheartedly. In addition to being a clnician, for a period of ten years I critically reviewed and summarized articles from peer-reviewed medical journals for a continuing medical educational company. There were so many conflicts of interest in the studies I read, it was almost unbelievable. The industry-sponsored studies nearly always presented the study results in a way that shed the best possible light on their product, even if the actual data did not support such conclusions. Having patient-level data for studies would usher in a new era of transparency (just as did having to register the trial and its original primary outcomes at clinicaltrials.gov). I wholeheartedly approve of your proposal to share deidentified patient data underlying the results presented in articles.

    6 Month Time Frame
    Comments: I think the 6-month time frame is too generous and should be shortened. It would not allow for prompt analysis of results of new studies, especially those that generate a lot of interest at the time of publication. Interest often wanes over time.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: I agree with the general approach, but fear that - in industry-sponsored studies - plans will be made for sharing that are, shall we say, difficult for others to follow and lead to less-than-complete collection of the data. How can this be guarded against?

    Providing Credit
    • I agree with this general approach
    Comments: I agree with this - certainly those who seek the truth about the data and are willing to go to the trouble of finding it and recording it should be credited. It needs to be clear that they do not have ANY conflict of interest whatsoever, in order to be credible.

    Other Comments: This is slightly off topic, but I also think that journals should not be allowed to list authors' conflicts of interest anywhere but in the article itself. No one has time to go to some obsure online appenedix somewhere to look up an author's conflicts. They need to be right there for the reader to see. And if the problem is that they take up too much space, maybe that should tell the editors of the journal something about the kind of articles they are accepting.

    Position:
    Comments:
  • David Saunders
    AFRIMS
    Role(s):
    • Researcher
    • Clinical trialist
    • Clinical trial sponsor / funder
    Date Submitted: Thursday, January 21, 2016 - 19:08

    Requirement To Share Data
    Comments: I do not agree that this is something that the ICMJE can or should require. While the principle appears to be sound at face value, one particular detail appears to have been omitted from consideration, and this is concerning - namely financial compensation for the use of the data. A typical clinical trial costs millions-100s of millions to conduct. Requiring investigators to simply give this information away to the general public, and particularly academic competitors could have significant 2nd and 3rd order consequences that must carefully be considered. In some sense, this is an 'unfunded mandate' by ICMJE as there is clearly no mechanism in place to recoup value of the use of this information. A waiver of all publication fees would seem to be a minimal requirement if this were to be enforced.

    6 Month Time Frame
    Comments: This timeframe appears to be arbitrary.

    Require a Data Sharing Plan
    Comments: The requirements that have been increasingly heaped on investigators in recent years by regulatory authorities have become so onerous, and to be difficult or impossible to comply with in many cases. I suspect this would drive at least some authors to seek out new ways of publishing information that 'cuts out the middle man' to leverage the full value of the data and recoup the costs. Otherwise, it is very likely that there will be a new class of meta-analysts who make their living freely off the hard work and financial resources of those who produce the primary data.

    Providing Credit
    • I agree with this general approach
    Comments: While this would seem to be a necessary pre-condition for even considering such an initiative, credit for the effort seems to be less of a concern than who will benefit financially from the new requirements. Until there is a clear mechanism and funding in place to appropriately compensate sponsors and investigators for the use of the data, this initiative, while high-minded, appears to be nothing more than an unfunded mandate. Another issue which needs to be carefully considered is how competitors might attempt to recast each others data in negative ways in order to promote their own products or findings. Such unethical metanalyses could conceivably include partial or edited datasets from competitors to reconstruct 'virtual' head to head trials. It would be quite easy to obscure the validity of the results of such studies, much as it is a present to omit unfavorable data from published reports. In attempting to solve an existing problem, this initiative would clearly lead to unintended consequences.

    Position:
    Comments:
  • Carson Reider, PhD
    The Ohio State University
    Role(s): Researcher
    Date Submitted: Thursday, January 21, 2016 - 17:49

    Requirement To Share Data
    Comments: It would seem the most efficient way to accommodate this would be for journals to enforce this requirement based upon review of the required to be completed fields within ClinicalTrials.gov; rather than requesting the same information of the authors.

    6 Month Time Frame
    Comments: it should be congruent with the ClinicalTrials.gov requirements for posting results- see previous comment.

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

    Providing Credit
    • I agree with this general approach

    Position:
    Comments:

Pages