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

Displaying 51 - 55 of 320 comments
  • Craig French
    Australia and New Zealand Intensive Care Society Clinical Trials Group
    Role(s):
    • Researcher
    • Clinician
    • Clinical trialist
    Date Submitted: Saturday, April 16, 2016 - 03:43

    Requirement To Share Data
    • I agree with this general approach
    Comments: The Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) recognises the potential benefit to patients that sharing of clinical trial data offers. Maximising these benefits requires careful consideration of the associated risks; namely the potential for unscientific post hoc analyses that could undermine trust in clinical trials or result in inappropriate and harmful practice change. To mitigate these risks we support a ‘controlled access’ model that requires data to be shared only for the purposes of replication of primary analyses or to conduct an a priori defined, hypothesis‐driven, secondary analysis. It is crucial that sharing of clinical trial data only occurs in accordance with an agreed data sharing plan that respects the ethical, regulatory, and legal rights and responsibilities of the participants, primary investigators and sponsors. One particular concern for those involved in investigator‐initiated research is that a workable model will require funding and infrastructure and groups like ours already operate with very limited resources. We believe that a statement from the ICMJE that advocates that funding agencies allocate resources to data sharing activities would be appropriate.

    6 Month Time Frame
    Comments: Investigators will often wish to conduct post‐hoc exploratory analyses of their data and these often take much longer than six months to complete. We consider that six months is a reasonable timeframe for investigators to publicly declare any post‐hoc exploratory analyses that they intend to undertake and a timeframe for completing such analyses. However, six months is not a realistic amount of time to complete these analyses. While a six month timeframe may be appropriate for sharing data solely for the purpose of replicating the primary analyses, we consider that the appropriate timeframe for providing access to trial data for other purposes will differ depending on the circumstances. We support a flexible system that allows for the timeframe for data sharing to be specified in the data sharing plan and an allowance for this timeframe to vary depending on the nature of the data being shared. We suggest that reasonable timeframes would be a maximum of six months for requests to replicate primary analyses and a maximum of two years for most other requests.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: ANZICS CTG strongly believes that a data sharing plan is essential to protect the interests of trial participants, researchers, trial sponsors, and the community. If the ICJME requires data sharing as a component of trial registration the ANZICS CTG recommends a ‘controlled access’ model. Such a model requires a robust governance process that complies with relevant ethical, legal, and regulatory requirements and details 1. The submission process 2. Who adjudicates the request 3. The assessment criteria used 4. The limitations of use including an access agreement 5. How the results of the research will be published 6. Any fees involved 7. An independent appeal process in the event of a data request being refused.

    Providing Credit
    • I agree with this general approach
    Comments: ANZICS CTG believes that to recognise the contribution made by researchers at least one author of the original study be offered co‐authorship. In the event that the original study authors do not wish to be acknowledged as co‐authors the manuscript should state this. Furthermore, where primary author(s) do not take up the opportunity to be co‐authors on secondary publications they should be given the opportunity to provide contemporaneous commentary to any resulting publication outlining their views regarding the strengths and weaknesses of the secondary analysis.

    Other Comments: The ANZICS-CTG is an investigator-initiated clinical trials group that has always supported the principle of data sharing for endorsed studies (could attach a copy of our Terms of Reference). The ANZICS-CTG has also been aware of the constraints of limited funding and infrastructure for this activity for investigator initiated research. The principal that has been employed in the past is that external requesters approach the study management committee who consider each request primarily on scientific merit, but also in the context of the required resources and costs involved. Lack of infrastructure at Research Methods Centres for this activity and the absence of funding within project budgets has been a major hurdle.

    Position:
    Comments:
  • Prof. Dr. Martin Dugas
    University of Münster, Germany
    Role(s): Researcher
    Date Submitted: Saturday, April 16, 2016 - 00:25

    Requirement To Share Data
    • I agree with this general approach
    Comments: 1) The COMPLETE set of case report forms (CRFs) must also be published. This is important to understand the context of collected data. Access to CRFs is key to learn for future trials and to foster compatible data sets (see http://www.ncbi.nlm.nih.gov/pubmed/26108979 and http://www.ncbi.nlm.nih.gov/pubmed/26868052) 2) Sharing patient data is not enough for reproducible research. Source code of statistical programs must also be published. 3) There are different approaches for patient data deidentification. Many deidentification approaches have a substantial re-identification risk for patients. Therefore guidelines for patient data deidentification are needed and informed consent forms need to be updated regarding data sharing and re-identification risks.

    6 Month Time Frame
    Comments: Why wait 6 months? A publication should be self-contained and provide the best possible evidence. This delay will lead to a fragmented discussion: Some publications might be very promising in the beginning and then heavily criticized after 6 months when patient data is accessible.

    Require a Data Sharing Plan
    Comments: We really don’t need more bureaucracy in clinical trials. We need access to the full set of CRFs and to the relevant part of deidentified IPD.

    Providing Credit
    Comments: Sharing metadata and data of clinical trials should be the norm. If data cannot be shared, the paper is less credible and therefore should be published in less prestigous journals.

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    Comments:
  • Theresa Thomas
    Incyte Corporation
    Role(s): Other
      • Contract Specialists
    Date Submitted: Friday, April 15, 2016 - 21:27

    Requirement To Share Data
    • I agree with this general approach
    Comments: As investigators, sponsors and the medical journals should share responsibly how clinical trial data is used for utility by the research industry. The clinical trials and patient data is regulated by the individual IRBs and thus as due to the research industry would benefit additional research for academia and the respective foundations whom mission is to contribute through endowment of specific interest

    6 Month Time Frame

    Require a Data Sharing Plan

    Providing Credit

    Position:
    Comments:
  • Theresa Thomas
    Incyte Corporation
    Role(s): Other
      • L
    Date Submitted: Friday, April 15, 2016 - 21:25

    Requirement To Share Data

    6 Month Time Frame

    Require a Data Sharing Plan

    Providing Credit

    Position:
    Comments:
  • Yale Open Data Access (YODA) Project (Ross JS, Krumholz HM, Gross CP, Desai N, Lehman R)
    Yale University
    Role(s):
    • Researcher
    • Clinician
    Date Submitted: Friday, April 15, 2016 - 17:13

    Requirement To Share Data
    • I agree with this general approach
    Comments: We support and applaud the ICMJE’s proposal for sharing clinical trial data as a condition of publication. While the proposal clearly states that all deidentified IPD underlying the results presented in the article are required to be shared, as well as any related metadata, we believe this proposal could be strengthened by more explicitly defining the metadata. The metadata needed to understand and make use of data includes, but is not limited to, blank case report forms, data definitions and specifications, trial protocols with any amendments, analysis plans, and clinical study reports. We also believe that the ICMJE proposal could be further strengthened if it were broadened to include all deidentified IPD associated with the conduct of the published clinical trial – the complete and final trial data – not just the deidentified IPD underlying the published results. We are concerned that as investigators publish multiple articles, multiple data sets for the same trial will be shared, creating version control issues and potential confusion. Furthermore, sharing the complete and final trial data will best enable this shared resource to be used for additional research on secondary endpoints and subgroup populations, not just to validate published findings.

    6 Month Time Frame
    • I agree with this general approach
    Comments: We support and applaud the ICMJE’s proposal to require sharing of clinical trial data within 6 months of publication. This represents a reasonable timeframe that allows investigators sufficient time to prepare the deidentified IPD and metadata. However, it is worth noting that interest in a clinical study is never higher than at the time of its publication and the ICMJE could consider capitalizing on this interest by requiring sharing of clinical trial data upon publication. Absent this, we would strongly encourage the ICMJE to require submission of a clear and detailed data sharing plan to be considered by the editors that would in turn be publicly-disseminated at the time of article publication. Investigators will vary in their ability to adequately prepare and share deidentified IPD and metadata associated with their clinical study. ICMJE member journals are in the best position to provide advice, oversight and assurance of data sharing compliance at 6 months if the data sharing plan is reviewed as part of the article submission process and is published as part of, or in coordination with, article publication.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: We support and applaud the ICMJE’s proposal that authors include a plan for data sharing as a component of clinical trial registration and include a description of the data sharing plan as part of the submitted manuscript. However, we believe this proposal could be strengthened by more explicitly defining the aspects of the data sharing plan that will be a component of clinical trial registration and described in the publication. The use of free text fields by clinical trial registries will likely lead to data sharing plans of limited specificity, with no clear party responsible for compliance. Similarly, given word limit requirements for many ICMJE-member journals, published data sharing plans are likely to be brief, without clear details. Specific aspects of any data sharing plan that should be described include the data repository to be used (if any), process for requesting shared data, materials to be shared, and mechanism by which data access will be provided to external investigators, as well as other data-sharing plan elements outlined in the 2015 Institute of Medicine Report. As noted earlier, the data sharing plan should be reviewed by the editors as part of the article submission and publication process.

    Providing Credit
    • I agree with this general approach
    Comments: We strongly agree with the ICMJE that a means of providing appropriate credit for generating and sharing clinical trial data needs to be developed and recognized in the academic community. We would suggest the following ideas for providing such credit. First, any published article that was made possible through shared data should include explicit acknowledgement, including a statement to the effect of “This study used data from CLINICAL TRIAL (NCTXXXXXXXX) that was made available by INVESTIGATORS through DATA SHARING PLATFORM; data can be requested by BRIEF DIRECTIONS.” Second, the ICMJE should work with the National Library of Medicine of the U.S. National Institutes of Health to develop a mechanism that would allow citations to data, perhaps using NCT numbers (or another unique identifier), thereby allowing all investigators who contributed to the collection of the data to receive credit for the number of articles that were published using the shared data. Finally, any “trial citation index” should be taken into account by the academic community when making promotion decision, so that investigators receive credit not only for the number and prestige associated with articles they have authored, but also for articles that were made possible by data they shared.

    Other Comments: Currently lacking from the ICMJE’s proposal is specification of penalty(ies) for investigators who do not share deidentified IPD within the 6 month timeframe. We believe this proposal could be strengthened by explicitly defining penalty(ies), such as exclusion of all associated trial authors from publishing articles in ICMJE member journals for a 3 year period. Other issues to consider: First, as investigators will be responsible for preparing data to be shared, which includes protecting patient privacy, resources will be required for best-practice deidentification (http://dx.doi.org/10.1136/bmj.h1139; http://dx.doi.org/10.1136/bmj.c181). The ICMJE should advocate that clinical trial funding organizations provide budgetary support for data sharing efforts. Second, the ICMJE should advocate that Institutional Review Boards adopt Informed Consent forms that explicitly permit data sharing, ensuring that trial participants are aware of data sharing plans. Finally, the ICMJE noted that authors of secondary analyses must explain completely how theirs differ from previous analyses as a safeguard. While we agree that such discussion is critical to any published article using shared data, we anticipate frequent differences among authors in analysis and interpretation of the same data source, which will enhance, not diminish, understanding of the clinical trial.

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