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

Displaying 11 - 15 of 320 comments
  • Patricia Thibodeau
    Association of Academic Health Science Libraries (AAHSL)
    Role(s): Other
      • health sciences librarian
    Date Submitted: Monday, April 18, 2016 - 14:03

    Requirement To Share Data
    • I agree with this general approach
    Comments: The Association of Academic Health Sciences Libraries (AAHSL) and its members applaud ICMJE for requiring data sharing. It moves ICMJE member journals a step beyond providing public access to published articles. Having the underlying data publicly available will be beneficial to the post review of published works as well as enabling other researchers to conduct future studies. It will also enhance future research by allowing researchers to reuse and supplement extant data sets, eliminating potential duplication of research efforts.

    6 Month Time Frame
    Comments: As health sciences librarians, AAHSL members support timeframes that promote more immediate sharing of research data. However, AAHSL members also recognize that many biomedical researchers will prefer the 12-month timeframe. While access to data is important, researchers want to analyze and publish the results of their data in different ways, generating more than one publication from the same data set. Many biomedical researchers would prefer the 12-month timeframe to accomplish additional analysis and the development of manuscripts. ICMJE will also need to consider how compliance with the final timeframe will be tracked after publication.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: In addition to making data accessible and enhancing transparency, requiring a data sharing plan ensures that researchers have considered the issues of privacy, confidentiality and de-identification of data before making it available. They also need to identify a stable and sustainable platform for ensuring the data will be shareable and accessible into the future. As stated in the ICMJE editorial, the Committee “already requires the prospective registration of all clinical trials prior to enrollment of the first participant. “ Since ClinicalTrials.gov has added this element, this requirement should be easy to meet for many researchers. AAHSL fully supports ICMJE’s urging of other trial registries to provide a similar element for data sharing plans.

    Providing Credit
    • I agree with this general approach
    Comments: AAHSL also supports ICMJE in clearly laying out safeguards for protecting the rights of investigators and sponsors, as well as the recognition of the original work. It is important for researchers that deposition of data not be considered a prior publication. Authors of secondary analyses should be required to state that their use of the data is in accordance with the terms of sharing the data, clearly identify the dataset using a unique identifier and include a statement as to how the secondary analysis differed from previous analyses. Tracking data and its use is a major consideration. Citing the source of the original data through a unique identifier must be done to recognize the contributions of the original research work and ensure that the subsequent use of data sets can be found and linked to a specific trial. The NCT number is a logical option to consider. In addition, having it placed in a separate standardized field that can searched within databases or at least referenced in any publications resulting from secondary analysis would enable linking all publications to one dataset. Currently these numbers are not standardly placed in PubMed or other databases.

    Other Comments: AAHSL supports ICMJE’s proposed requirements and believes they are an excellent step forward in ensuring that data are accessible and shareable for both current and future research endeavors.

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  • Public Responsibility in Medicine and Research
    Public Responsibility in Medicine and Research (PRIM&R)
    Role(s): Other
      • research ethics educator
    Date Submitted: Monday, April 18, 2016 - 14:01

    Requirement To Share Data
    • I agree with this general approach
    Comments: PRIM&R fully supports initiatives to promote data sharing. The public availability of patient-level data can optimize the use and novel reanalysis of existing data sets, foster collaboration, enhance accountability and reduce research redundancy. By enhancing the scientific contribution of clinical trials and society’s investment in them, data sharing supports the ethical justification for clinical research participation itself. We ask individuals to assume risks and burdens associated with being research subjects for the benefit of science and public health. Data sharing multiplies the value of clinical trials and thereby honors subjects’ contributions to research. But the value of data sharing is not without risk. Industry and academia have expressed concerns about subject privacy, costs and burdens, and unwanted impact on academic incentives and intellectual property rights, to name a few. PRIM&R asks whether the ICMJE alone is best positioned to consider and implement this substantial change to research policy and practice. We recommend thoughtful policy development related to privacy concerns, sensitivity to intellectual property matters, and a revision to the definition of “clinical trial” which is overly broad and encompasses research for which the balance of benefit and burden associated with the requirement is not reasonable.

    6 Month Time Frame
    Comments: For some studies, the 6 month timeframe will not be problematic, but for others—depending on the nature of the research—a longer timeframe, such as one or even two years, may be more appropriate (for example, for complex studies that involve multiple sub-analyses). Requiring the primary investigators to share data within 6 months could motivate them to delay publication of research because they believe they need time to conduct additional analyses with their data and are concerned that releasing their data before such analyses are complete will be detrimental to their ability to publish their research. This outcome would be bad for scientific progress and patient safety. To address this possibility, PRIM&R suggests that ICMJE allow investigators to propose at the time of registration a reasonable alternative (but definitive) timeline within which they will share their patient-level data. ICMJE should also explore innovative ways to facilitate data sharing by researchers planning multiple articles from one data set. Finally, PRIM&R recommends that ICMJE consider developing an independent process to determine whether the data have been adequately de-identified and the security of information is properly maintained. The process should include expertise in human subjects research and privacy protection.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: We support requiring authors to include a plan for data sharing as a component of clinical trial registration. Increased transparency fosters public trust in the research enterprise. However, we recommend that ICMJE provide further details on what constitutes an acceptable data sharing plan. ICMJE should clarify, for instance, whether the requirement for data sharing entails that data sharing plans will be reviewed as part of manuscript review, or whether the mere existence of a plan at the time of submission will be considered adequate to meet the requirement. Furthermore, the proposal does not make adequate provision for changes to data sharing plans. Researchers generating data may make changes to their protocols after registering their trial and providing a plan for data sharing. They may also decide there is a better mechanism for disclosing data after the original plan has been submitted. Disputes may arise between the original data generators and those who later request data access about whether the new data sharing plan is adequate. It is unclear how such disputes would be adjudicated. PRIM&R recommends that ICMJE consider developing an independent committee to resolve disputes in this area, and that the committee include a human subjects research representative.

    Providing Credit
    • I agree with this general approach
    Comments: PRIM&R strongly agrees that those who generate and then share clinical trial data sets deserve credit for their efforts and work product. Without such credit, data sharing could be detrimental to researchers’ careers and, by extension, to the advancement of science. We agree that when collaboration between secondary data users and data generators is mutually beneficial, it may be an appropriate method for crediting data generators for their work. But when it is not a viable option, we recommend that journal editors ensure that the source of data is always clear in publications. This will ensure that data-generators are given appropriate credit in any secondary analyses of the data and that their institutions have a basis on which to give them appropriate academic or professional recognition, for instance, during merit-review or tenure-decision processes.

    Other Comments: Guidance will need to be developed for IRB review of data sharing plans with respect to the adequacy of measures taken for protecting subject privacy and confidentiality.   IRBs will be key partners in ensuring that informed consent processes include appropriate and understandable information about data sharing and conditions under which information will be shared. ICMJE should encourage researchers to inform their IRBs at the start of research about their plan for data sharing, so that the IRBs can advise the researchers about what human subjects need to know about data sharing. PRIM&R encourages ICMJE’s members to engage the scientific community in a dialogue about how best to pay for new data sharing requirements. PRIM&R supports responsible collaboration and careful use of shared data. Policy should encourage authors of secondary analyses to incorporate important details such as inclusion/exclusion criteria, study location, and how end points were measured, where relevant. In addition, any systematic reviews or meta-analyses must address differences in study design. Finally, ICMJE should call for and participate in the development of ethical standards for the conduct of secondary analyses on shared data.

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  • Robert Sheldon
    University of Calgary
    Role(s):
    • Researcher
    • Clinician
    • Clinical trialist
    Date Submitted: Monday, April 18, 2016 - 13:53

    Requirement To Share Data
    • I agree with this general approach
    Comments: I completely agree with the general approach, and indeed in Canada the investigators of the Canadian Arrhythmia Network, a federally-funded network of investigators that will receive approximately $65 million over 5 years, have developed a set of sharing rules. These are based on public well being. intellectual property, closeness to the study and network, and effort. While preparing this we were cognizant of large centres in Canada that are indeed data parasites: never enrol, always happy to have the data. It is not your principle that is the problem; it is its execution. I note that the people who prefer immediate data dumping lack an MD, and therefore are clueless about the effort involved in conducting clinical trials. The NEJM editorial was in fact completely correct.

    6 Month Time Frame
    Comments: No. No. Six months is far too short for already heavily burdened centres, many of whom conduct agency-funded clinical trials without the deep pockets and vast resources of industry.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: But not 6 months. Frankly it makes me wonder how many of the editors have ever conducted a clinical trial. This time span is so short it leads to the conjecture that it is a stalking horse for a more reasonable time.

    Providing Credit
    Comments: Authorship, only. The conduct of clinical trials requires an enormous effort, and its recognition requires more than a fine-print acknowledgment written by one and ignored by all.

    Other Comments: There is a concept called Stakeholder Engagement. I don't suppose it occurred to the editors to, well, engage their stakeholders? Or have the revealed their authoritarian nature?

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  • Fiocruz Clinical Research Network (Brazil)
    Fiocruz
    Role(s):
    • Researcher
    • Clinical trial sponsor / funder
    • Other
      • Network of clinical research groups within a brazilian public R&D instituition
    Date Submitted: Monday, April 18, 2016 - 13:42

    Requirement To Share Data
    • I agree with this general approach
    Comments: The Fiocruz Clinical Research Network, created in November 2012, includes 32 clinical research groups at Fiocruz, main R&D public health institution in Brazil. The primary objective of the network is to strengthen the strategic role of clinical research carried out in the institution, overcoming technological hurdles in the country, and contributing to the achievement of autonomy and self-sufficiency in the development of rational health processes and products for the Brazilian population. One of the objectives of the network is to establish a forum for discussion of the situation and priorities of clinical research in Brazil. The public consultation from ICMJE was discussed by members of the network in a meeting on 13th April 2016 in Rio de Janeiro. The network recognizes the importance of clinical trials data widely available and welcomes proposals to enhance transparency in clinical research. In this context, sharing deidentified IPD is an important approach. However, our discussion brought some questions regarding the implementation of this proposal. The main one is regarding what is it exactly regarded as IPD. We believe that there is a need for a more clear definition of IPD. There is a need to define the desirable requirements of the trial datasets.

    6 Month Time Frame
    • I agree with this general approach
    Comments: Generally, we agree on setting a timeframe for sharing IPD following publication. However, our discussion brought some issues on this: Will all clinical trial registries be aligned with ICMJE´s approach, especially regarding requirements for sharing IPD meeting the proposed deadline? How will this be guaranteed? Will the researchers or the sponsors be responsible for sharing the data? The one-year period suggested in the editorial might not be enough to allow registries to adapt.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: Our discussion about the data-sharing plan showed a need for guidance on how to set such a plan, including acceptability for different levels of sharing. We will foster responsible clinical trial data sharing among our researchers.

    Providing Credit
    • I agree with this general approach
    Comments: We agree that means of providing credit to those sharing clinical data sets need to be developed. Universities and research & development institutions should work on mechanisms to promote sharing of data as well as to acknowledge those who make data from clinical trials widely accessible. The scientific community should find a way for recognizing those who share in the same way it recognizes, for instance, quantity and quality of publications. Sharing of data could become a criteria (even if secondary) in researchers´ career record. We believe that those who share data might naturally be invited to get involved in new analyses and papers resulting from those datasets, allowing them to co-author those. Even if there is no interest in setting such collaborations beyond sharing of data, those sharing should be acknowledge at any case.

    Other Comments: At last, we suggest clinical trials data sharing be included in the EQUATOR initiatives, i.e. the CONSORT statement in order to build appropriate guidance for researchers.

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  • Tuli Ahmed
    JetStream Clinical, LLC
    Role(s): Other
      • Medical Publications Professional
    Date Submitted: Monday, April 18, 2016 - 12:51

    Requirement To Share Data
    Comments: I strongly disagree with the patient-level data-sharing proposal. If a data-sharing rule were to be implemented by journals, the pharmaceutical, biotech, device, and diagnostics industries would need to delay publication of early studies in order to protect the product from being patented for additional indications by outside sources. At the early stage of research, it is unknown how many indications can be patented. A data-sharing rule would create a disincentive to publish data in a timely manner and would inhibit timely scientific exchange. Additionally, providing patient-level data to the world of non-statisticians opens the gate to the misuse of data and the generation of false conclusions.

    6 Month Time Frame

    Require a Data Sharing Plan

    Providing Credit

    Position:
    Comments:

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