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

Displaying 276 - 280 of 320 comments
  • Valerie M.
    none
    Role(s): Other
      • Citizen of the United States
    Date Submitted: Tuesday, January 26, 2016 - 10:50

    Requirement To Share Data
    • I agree with this general approach
    Comments: YES!!! As a member of the public and an engineer, I would appreciate data availability. Many people that are not scientific researchers are interested in seeing the data behind the claims. It would then be possible to look at what the researchers have assumed, and whether that fits with the data, ect. Yes, I would look at the data itself, and I believe others would as well. Also, being able to speed up research in the medical community is worth it. This is my health and the health of others that we are talking about. It is hard to believe that this isn't already required.

    6 Month Time Frame
    Comments: Data should be supplied upon publication. Why leave 6 months for the media to have a field day before validation and further scrutiny? How does a 6 month wait help anyone or anything? The researcher already has all of the data and presumably it is organized such that that researcher has been able to find any patterns ect. No wait is necessary.

    Require a Data Sharing Plan
    Comments: Create a website in which this data will be placed upon publication. No plan is necessary.

    Providing Credit
    • I agree with this general approach
    Comments: Having all data on a central website will also facilitate credential recognition. Require registration to download the data (none to view it). Registrants must submit their name, address, phone number, company affiliation, funding source, ect. The researchers that originally submitted the data can then have access(through registration upon publication) to the list of registrants for their project and can contact them, or just monitor to make sure they are sited in the new research. This of course does not eliminate the problems associated with pirated data. A way around that can also be through the website in which the data is submitted. Require that data be submitted electronically. That way it can be searched when a new study's data is placed on the website to see if the data is very similar or matches the data of another publication, and can also be checked to see if the correct references were cited.

    Other Comments: This is a win for everyone. Research will move along faster, errors and omissions can be caught, data can be pooled for larger more relevant analysis, competition between researchers will increase creating more research that either validates or invalidates previous research, cooperation between researchers may produce unforeseen positive results as differing minds collaborate! This is very exciting!

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  • Gerben ter Riet
    Dept General Practice AMC-University of Amsterdam
    Role(s): Researcher
    Date Submitted: Tuesday, January 26, 2016 - 10:43

    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

    Other Comments: I pushed the SEND button too early and sent an earlier comment that was incomplete using the address g.terriet@amc.nl. Apologies for double posting. Here I go again: The definition of clinical trial seems very wide, including projects WITHOUT concurrent comparison or control groups and not requiring randomization. It may also prove difficult to prove that investigators study cause and effect relationships, or conversely, they may deny it and one may get caught up in difficult discussions. What was the reason to go beyond RCTs?

    Position:
    Comments:
  • Filip
    Self - Fitness/ Nutrition Coach/ EMT
    Role(s): Other
      • Fitness/ Nutrition Coach/ EMT
    Date Submitted: Tuesday, January 26, 2016 - 10:39

    Requirement To Share Data
    • I agree with this general approach
    Comments: These data are difficult and expensive to gather, involve significant sacrifices from trial participants, and most importantly are critical to our evolving knowledge of human physiology and medical interventions. If all researchers share, then everyone benefits from the vastly increased access to information. Please get this done!

    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
    Comments: Grant giving organizations (governmental and NGOs) should tilt grants and loans towards those projects which involve primary research and direct collection of clinical trial data. It would require further political action, but perhaps some tax or requirement could be placed on pharmaceutical companies to help fund clinical trial data sets. Alternatively, there would be great demand from health insurance companies, medical device manufacturers and pharmaceutical companies for access to a centrally-managed pool of clinical trial data. Perhaps these for-profit organizations could be required to pay into a fund for such access.

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  • Gerben ter Riet
    Academic Medical Center-University Amsterdam, Dept General Practice
    Role(s): Researcher
    Date Submitted: Tuesday, January 26, 2016 - 10:30

    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

    Other Comments: I think that the definition of a "clinical trial" is very wide, including any research project that prospectively assigns people or a group of people to an intervention WITHOUT

    Position:
    Comments:
  • Susan Harvey
    Self/nonaffiliated
    Role(s): Other
      • Member of the public
    Date Submitted: Tuesday, January 26, 2016 - 09:52

    Requirement To Share Data
    • I agree with this general approach
    Comments: This seems to be a sensible & past due approach. If scientists & researchers are truly interested in solving problems, & especially if they receive public funding, they should welcome all the qualified help possible.

    6 Month Time Frame
    • I agree with this general approach
    Comments: Simply makes sense, in no way seems over burdensome or unfair to original researchers. It would save funds in terms of future research & would allow for addditional & timely use of current information. No need to reinvent the wheel, so to speak.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: Would ensure adherance to the rules, as well as inclusion of all data, not just that which authors wish to make public.

    Providing Credit
    • I agree with this general approach
    Comments: I agree absolutely. Credit should be given where it is due, just as in any other discipline. Original work deserves recognition.

    Position:
    Comments:

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