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

Displaying 41 - 45 of 320 comments
  • Lina Elizabeth Porras Santana
    Universidad de Granada
    Role(s): Researcher
    Date Submitted: Sunday, April 17, 2016 - 18:01

    Requirement To Share Data
    • I agree with this general approach

    6 Month Time Frame
    • I agree with this general approach
    Comments: 6 month is too much, the data should be open at the same time that the article is published as a supplementary material; if the group is thinking in use the data for other publications they should advise that the data will be use for that, in order that other people can not use for the same to avoid duplication.

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

    Providing Credit
    • I agree with this general approach
    Comments: An approach for that is the citation of the publication where the data came from and the use of modified license, could be creative commons (by-nc), having in mind that an article could not be understand as something profitable.

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  • Jennifer O'Callaghan
    Wellcome Trust, Clinical Data Sharing Manager
    Role(s): Clinical trial sponsor / funder
    Date Submitted: Sunday, April 17, 2016 - 17:22

    Requirement To Share Data
    • I agree with this general approach
    Comments: The Wellcome Trust agrees with this approach to share IPD data and any additional materials which will assist the reuse and analysis of existing datasets. However, we do suggest that the statement could usefully be reworded to "require authors to make accessible the de-identified individual patient level data...". Requiring authors to "share" necessitates having someone to share with, whereas this alternative language would clarify that the requirement is to make data available both now and in the future.

    6 Month Time Frame
    • I agree with this general approach
    Comments: Ideally all data should be made accessible at the time of publication, any exceptions to this should be carefully justified. The 6-month time period should be framed as the upper limit of time for researchers to use to get their data into a sharable format and not as a protected period within which to prepare more publications.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: The Wellcome Trust strongly supports this requirement which is in line with our data management and sharing policy. This requires researchers to provide a data sharing plan as part of grant applications, where they will generate data resources of wider value to the research community

    Providing Credit
    • I agree with this general approach
    Comments: The Wellcome Trust believes that it is important to recognise and credit data generators, sharers and users, especially within the academic community.. Both funders and journals have key roles to play in incentivising and crediting academics who share their research data and those researchers who use datasets for secondary analysis. We are committed as a funder to working in partnership with journals to address this challenge. In terms of possible action for journal, we believe that journals should adopt consistent practices for how datasets should be cited, so that there is a universal standard for citation. Unique data object identifiers (DOIs) are a possible option for making datasets citable and discoverable. Data descriptor articles are useful as a method for signposting other researchers to datasets for secondary analysis and simultaneously provide data generators with another publication for their record. Data authorship may be another option for assigning credit to data generators, whereby secondary data analysts include the data generator as an author on their paper where appropriate . Journals should consider secondary analysis papers as important as primary research papers and publish accordingly in order to incentivise the reuse of data and communicate to academia the importance of data sharing.

    Other Comments: To roll out this policy, there is a key need for a platform where academics can share clinical trial data in a way that will make their datasets easy to find, use and combine with other relevant datasets and information to maximise the benefits of their research to science and health. This would allow journals to enforce their data sharing mandate and to link data papers to the platform. We held an international meeting in partnership with Harvard MRCT in March 2016 to explore possible models for an overarching platform to enable discoverability and accessibility of clinical trial data. We welcome the active participation of journals in these conversations.

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  • Eduardo Franco
    McGill University
    Role(s):
    • Researcher
    • Clinical trialist
    Date Submitted: Sunday, April 17, 2016 - 17:14

    Requirement To Share Data
    Comments: A potential unintended consequence: The fact that patients’ data will be placed in the public domain implies that participants will need to be told at the time of study enrolment that this will ultimately happen when the study results are published; the informed consent form being the obvious document for disclosing this fact. Could this influence a patient’s decision to enter the study? Would concerns about confidentiality prevent the patient (or disease-free subject in some types of trials) from accepting to participate? The assurances of confidentiality that come from disclosing that the individual level data will be stripped of any identifiers may not be enough. Small trials will be particularly vulnerable. Even large CTs may as well. For instance, a multi-centre CT with many recruiting sites may have only a few patients for some sites. If a variable that identifies the site is part of the dataset an external reader of the dataset may be able to guess the identity of an individual. Omitting the site variable may not be an option if site happens to be a variable used in the analyses and is thus necessary for any confirmation of the results.

    6 Month Time Frame
    • I agree with this general approach
    Comments: Continuing from above: Of particular concern are CTs of conditions of high sensitivity for patients, such as sexually-transmitted diseases. CTs of agents that prevent transmission of a sexually-transmitted agent in couples engaged in sexual intercourse are an extreme example where breaches of confidentiality will be particularly serious. Participants may also worry about the need for trial information and findings to be available in perpetuity in the internet. In consequence, trials will have a difficult time recruiting participants and will ultimately be less representative of the source populations that stand to benefit from the health interventions under comparison.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: A related concern: Creation of a cottage industry of arm-chair data analysts: Much as today’s large datasets placed in the public domain (e.g., NHANES) have led to a new niche of epidemiological studies that do not require the hard work of collecting data, the existence of so much data freely available will foster a culture of opportunism. Investigators who lost their grants or are experiencing difficulty publishing because they lack their own studies will resort to quick incursions into the vastness of these repositories and find a dataset whose content is something they are familiar with. Such a dilettante way of using someone else’s data will be found contemptible by those who did the hard work of conducting a study and collecting the data. Even if ethical standards are defined for soliciting data use partnerships it is impossible to monitor misuses.

    Providing Credit
    Comments: I disagree that uses of trial be data be done outside of a specific collaboration with a defined plan and vetting of the proponents of the dataset.

    Other Comments: Final remarks: One can think of myriad ways in which rivalry, vindictiveness, or other forms of ill-intention, may lead someone to reanalyze data placed in the public domain to challenge a rival’s findings, to cast doubt on the reputation of a former colleague or boss, or to seek pseudo-evidence in favour of preconceived ideas. As example of the latter, there are many anti-vaccine activists who would love to mine the data from pharmaceutical company trials of vaccines that they consider harmful. These activists are equipped with sophisticated statistical analysis software. By searching for statistical significance for side effects among the hundreds that are typically investigated activists will no doubt make a big deal out of the few associations that always result from multiple comparisons. They will seek ways of belittling beneficial effects from vaccines, and attempt other nefarious data dredging activities. Alas, anti-vaccine activists and other types of ill-intentioned individuals are not worried about submitting their results to peer reviewed journals (which would hopefully catch their unscientific data dredging). They own blogs and will thus post their results as widely as they can promoting doubt and fostering the notion that scientists and pharma are evil-doers.

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  • Rodica Busui
    University of Michigan
    Role(s): Clinical trialist
    Date Submitted: Sunday, April 17, 2016 - 13:09

    Requirement To Share Data
    Comments: While such sharing sounds good in principle, it could seriously jeopardize 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: Only 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: This requires very clear and validated plans to be available to all to prevent inappropriate use of the data and ensure true collaborations. In addition, data analyses may be costly and it is unclear what funding mechanisms would be available

    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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  • Katherine Gold MD
    University of Michigan
    Role(s):
    • Researcher
    • Clinician
    Date Submitted: Sunday, April 17, 2016 - 07:32

    Requirement To Share Data
    Comments: I do research with families bereaved by stillbirth and infant death. For one of my studies, although my IRB has said they think I am now doing analysis of de-identified data, I have declined to change my IRB status because these are rare and dramatic events and I fear that theoretically someone with knowledge about a particular family could use enough of the variables to identify a family from the available variables. This was shown once in a NEJM article--about how one can identify participants from "deidentified" data. I think this proposal has the potential to cause substantial risk and harm to patients and is unethical.

    6 Month Time Frame
    Comments: This is a ridiculous proposal. I am an individual investigator--not part of a huge team--and it can take me a year or two to "clean" a large database. I could not vouch for the accuracy or robustness of my data set. As one example, I recently discovered that a variable provided to me by a State agency was actually WRONG. This was not discovered for about 2 years after completion of the study. I was only able to figure it out by knowing a couple of the participants and realizing the data didn't make sense. No secondary researcher would have been able to figure this out.

    Require a Data Sharing Plan
    Comments: I think this minimizes the work of the primary investigator and his/her ability to generate publications from their own work. Others may analyze the data before you (and may or may not interpret it correctly). This is harmful to us junior investigators who desperately need our own publications for advancement in our fields as well as future funding.

    Providing Credit

    Other Comments: I believe this is a well-meaning but hopelessly naive proposal which actually undercuts the fundamental fabric of patient confidentiality and protections. It introduces unrealistic expectations of researchers (remember most of us are working harder than before just to get a grant in the first place to do research), unbelievable workload requirements, and may compromise the very integrity of data quality that we all work so hard to achieve. I strongly oppose this proposal.

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