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

Displaying 311 - 315 of 320 comments
  • Theodore iwashyna
    U Michigan
    Role(s):
    • Researcher
    • Clinician
    • Patient
    Date Submitted: Thursday, January 21, 2016 - 08:45

    Requirement To Share Data
    • I agree with this general approach
    Comments: Wonderful. Consider also suggesting they include the analytic code for any derived variables reported in the manuscript // this will prevent lots of failures of replication resulting from alternative approaches to doing the data analysis rather than true failures

    6 Month Time Frame
    Comments: Synchronous with article is better to avoid delay to retraction

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

    Providing Credit
    • I agree with this general approach
    Comments: Huge

    Other Comments: Bravo

    Position:
    Comments:
  • Matt Bartlett
    Mayo Clinic
    Role(s):
    • Researcher
    • Clinician
    Date Submitted: Thursday, January 21, 2016 - 07:58

    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

    Position:
    Comments:
  • Roshani Sanghani, MD
    PD Hinduja National Hospital, Mumbai, India
    Role(s): Clinician
    Date Submitted: Thursday, January 21, 2016 - 07:18

    Requirement To Share Data
    • I agree with this general approach
    Comments: Enhanced transparency is a welcome change. We need research to be done primarily to advance patient interests, even if that means less profit for industry.

    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:
  • sandro pignata
    National Cancer Institute of Naples
    Role(s): Clinical trialist
    Date Submitted: Thursday, January 21, 2016 - 02:22

    Requirement To Share Data
    • I agree with this general approach
    Comments: It seems to me a very important initiative. thank you

    6 Month Time Frame
    • I agree with this general approach

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

    Providing Credit

    Position:
    Comments:
  • Roger Bumgarner
    University of Washington, Department of Microbiology
    Role(s):
    • Researcher
    • Patient
    Date Submitted: Wednesday, January 20, 2016 - 13:08

    Requirement To Share Data
    Comments: This approach does not go far enough. Data should be release concurrent with publication as it is impossible for one to fully evaluate the research without the data. Moreover, authors of secondary analyses should only be required to acknowledge the source as opposed to the current statement of " authors of secondary analyses using these shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt." De-identified data should be public and used for the public good as a condition of publication. Restrictions on secondary analyses that are placed on the data by the primary authors are likely designed to benefit the primary authors and not science in general.

    6 Month Time Frame
    Comments: See above

    Require a Data Sharing Plan
    Comments: See above

    Providing Credit
    Comments: Requiring acknowledgement is sufficient. Secondary analyses should not be restricted by primary authors' desires or needs to milk their research for all it's worth. This lesson has been learned previously in the genomics community and ICMJE could learn a lot from the model developed there. As scientists and clinicians, the most important obligation is to the patients and study subjects. We need to do all we can to assure that their contributions generate the most value. Open, immediate and unrestricted access to data is the best way to accomplish this. Strong research teams will get the credit they deserve and already have the benefit of seeing the data prior to anyone else.

    Position:
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