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

Displaying 36 - 40 of 320 comments
  • Australian New Zealand Clinical Trials Registry (ANZCTR)
    ANZCTR
    Role(s): Other
      • Clinical trials registry
    Date Submitted: Monday, April 18, 2016 - 00:05

    Requirement To Share Data
    • I agree with this general approach
    Comments: Whilst we support this in principle and are happy to include a field on our registration form in which registrants can specify where they will be sharing their IPD, we do not have the resources to store and provide access to IPD within the registry. This would require a significant increase in resources and we would encourage the use of a neutral platform for trial results reporting outside of clinical trials registries.

    6 Month Time Frame
    • I agree with this general approach

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: In support of this requirement, we are willing to add a relevant data sharing field to the ANZCTR registration form. However, the ICMJE will need to coordinate with registries to produce a set of consistent minimum standards for these data sharing fields if they are to fulfil their purpose. The ANZCTR registration form already has the option for registrants to attach any relevant documents relating to their trial. This can easily be updated to include and/or enforce the attachment of documents relating to data sharing. In addition, we will continue to encourage registrants to update their trial records through regular automated reminder emails, to ensure that summary results and IPD availability information is kept as accurate and up to date as possible in trial records.

    Providing Credit
    • I agree with this general approach

    Other Comments: We would encourage the ICMJE to include the ICTRP registries in the discussion surrounding these or future proposals to clinical trial data sharing, in particular where clinical trials registries are expected to play a role in their implementation. The ICMJE will need to liaise with ICTRP registries in addition to Clinicaltrials.gov in order for information regarding data sharing in registered trial records to be of sufficient detail and consistency, and for these proposed requirements to have the impact required.

    Position:
    Comments:
  • Professor Kate Leslie
    Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA CTN)
    Role(s):
    • Researcher
    • Clinician
    • Clinical trialist
    Date Submitted: Sunday, April 17, 2016 - 22:34

    Requirement To Share Data
    Comments: The ANZCA CTN Executive supports the concept of data sharing for the following reasons: 1. Many patients expect that their participation in research will result in as much benefit as possible to science and other patients. 2. Funders (including tax payers) want as much value for money as possible. 3. Sharing data may allow confirmation of the original results and exploration of new hypotheses. 4. Sharing data may facilitate teaching, particularly in research methods and biostatistics. 5. The prospect of sharing data may have the secondary benefit of improving data collection, cleaning and analysis.

    6 Month Time Frame
    Comments: The 6-month time frame from original publication is too short. The ANZCA CTN spends 2-3 years after the original publication in completing a series of pre-planned sub-studies and sub-analyses. We believe that it is our prerogative to conduct these studies and not investigators seeking to share the data.

    Require a Data Sharing Plan

    Providing Credit
    Comments: The clinician investigators involved in ANZCA CTN studies put their heart and soul into their studies. They spend many years working up proposals, obtaining funding, establishing the network of centres and completing data collection. As clinician investigators much of this activity is undertaken pro bono. The current proposal does not adequately recognise the contributions of the owners of the data relative to those seeking to share it.

    Other Comments: The ANZCA CTN Executive is very concerned about the impact of the current proposal on the work of groups like the ANZCA CTN: 1. Sharing data would involve additional expense to the trial that would need to be met by funders or by those seeking to share the data. The additional expense includes preparing appropriate data dictionaries, holding steering committee meetings to consider requests and finalising contracts with those seeking to share the data. 2. Some patients, including the Aboriginal and Torres Strait Islander people of Australia and the Māori of New Zealand, have concerns about their sharing of their personal information. Their interests must be considered in any decisions about mandatory data sharing. 3. The proposal will reduce the amount of primary clinical trial research that is done, in favour of statistical analyses that do not require years of work and millions of dollars of funding. This will be to the detriment of science and patient care. 4. The proposal arose from concern about the integrity of industry-sponsored research but places more burden and risk upon investigator-initiated research, which is clearly focused on the public good.

    Position:
    Comments:
  • Professor Anushka Patel
    The George Institute for Global Health
    Role(s): Other
      • This submission was prepared on behalf of the George Institute for Global Health.
    Date Submitted: Sunday, April 17, 2016 - 20:57

    Requirement To Share Data
    Comments: The George Institute for Global Health recognises the potential substantial community benefit that sharing of de-identified clinical trial data offers, but is concerned that some risks have not been adequately acknowledged. While the need for a pre-specified hypothesis and analysis plan that serves a genuine scientific and / or public safety need should be a fundamental requirement for any new analyses, safeguards against misuse of data that serve specific interest groups must also be put in place. In particular, the original investigators should have the right to refuse to share the data with any individual, group or entity that has a demonstrable major conflict of interest. If the ICMJE proposal to share IPD underlying the results presented is limited to the purposes of confirming the reported findings (as opposed to testing new hypotheses), reasonable right of refusal of data sharing should also be granted if the proposed analysis plan is scientifically flawed in the view of the original authors.

    6 Month Time Frame
    Comments: While a 6 month timeframe may be reasonable for the sole purpose of replicating presented results using a scientifically sound analysis plan, this is an unreasonable timeframe to allow the original investigators to fairly benefit from what is often years of work with a large number of collaborators, many of whom have a reasonable expectation of leading subsidiary analyses. All original pre-specified analyses should be the preserve of the original trial group, within a reasonable timeframe likely to be greater than 12 months. Furthermore, identified post hoc analyses – either as subgroup or mechanistic analyses should also remain within the prerogative of the original investigators provided these are identified either as actual or potential analyses at the time of primary publication and a reasonable timeframe is proposed. It should be recognized that limited resources, especially for investigator-initiated studies involving busy clinician scientists, often constrain rapid testing of new hypotheses of scientific value.

    Require a Data Sharing Plan
    Comments: The George Institute strongly supports the provision of a data sharing plan (based on the principles articulated by the IOM) as a component of clinical trial registration. However, journals must accept data sharing plans that include reasonable grounds of refusal to share. This is likely to apply to a small minority of data requests, but is a crucial safeguard against data misuse. Grounds for reasonable refusal should include requests from individuals, groups or entities with a demonstrable conflict of interest, where the proposed hypothesis falls under the original trial group’s pre-specified or specified post-hoc analyses plan (all limited by reasonable timeframes), and when the requesting party’s analysis plan is considered scientifically flawed. If feasible, the ICMJE needs to consider an appropriate governance process to oversee and adjudicate appeals against data sharing refusals made on these grounds. In addition to requiring requests to meet ethical and regulatory obligations, data sharing plans should include detailed information on submission requirements, how requests will be handled, timeframes for data availability, the basis for reasonable refusal and any internal appeal process, requirements around original investigator acknowledgment and/or involvement, the requirements of any data access agreement and the associated fees that may apply.

    Providing Credit
    Comments: The George Institute believes that appropriate recognition of the contribution made by the original researchers must be agreed to as part of any data sharing agreement. This may or may not include authorship by one or more members of the original research group, and should be negotiated on a case-by-case basis. In the event that co-authorship does not occur, the original research group must be provided an opportunity (within a reasonable time period) to view and comment on any publications that arise from shared data. Furthermore, the publishing journal should provide an opportunity for the original research group to provide a short co-published commentary to raise any concerns about how the data were used and analysed in the publication. The ICMJE needs to acknowledge that the deep understanding that researchers develop around data generated from long and often complex trials can provide insights not readily appreciated by new users of the data, even with the provision of adequate metadata.

    Other Comments: The ICMJE should not under-estimate the resources that will be required to establish systems to appropriately store and curate data, and implement data sharing processes. While funders of research should ideally underwrite such costs, there is no guarantee that this will occur within the timeframe for the policy implementation. Researchers must have the right to charge reasonable fees for processing data sharing requests, as well as sharing data. Researchers should have the option of maintaining the data within their institutions in perpetuity or placing all the data in a public repository at a time of their choosing. Medical regulators may also have a role in holding data once agreement has been obtained from primary investigators.

    Position:
    Comments:
  • Adrian Burton
    Australian National Data Service
    Role(s): Other
      • Research Infrastructure Provider
    Date Submitted: Sunday, April 17, 2016 - 20:55

    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
    Comments: The Australian National Data Service (ANDS) believes that to support data sharing in a manner that is consistent with international best practice, the ICMJE proposal should include a policy endorsing the formal citation of data as a findable and reusable first class research output. The policy would ensure that where data is reused, it is appropriately acknowledged through established referencing systems in the same way as other scholarly outputs such as journal articles. An ICMJE data citation policy would be the appropriate complement to the proposed data sharing directive as it protects the interests of the data sharer and lays the proper scholarly foundation for both research integrity and innovation. The formal citation of data offers multiple benefits: appropriate acknowledgement for the data producer or collector formal identification of the data used and access arrangements for the data enhanced ability for citation services, such as Thomson Reuters Data Citation Index, to track data reuse and capture citation metrics for data As the practice of data citation is gaining momentum across the global scholarly community, the ICMJE data citation policy could draw principles, policy, and practice from existing initiatives such as the FORCE 11 Data Citation Principles, CODATA and DataCite.

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    Comments:
  • Joanne Waldstreicher, M.D. - Chief Medical Officer, Johnson & Johnson
    Janssen Pharmaceutical Companies of Johnson & Johnson
    Role(s): Clinical trial sponsor / funder
    Date Submitted: Sunday, April 17, 2016 - 20:34

    Requirement To Share Data
    • I agree with this general approach
    Comments: We agree with the general approach and appreciate the direction in the ICMJE proposal to allow data sharing via either open (e.g., public repositories, the PRO-ACT database of ALS trials (http://nctu.partners.org/ProACT/Document/DisplayLatest/2) or controlled access, as described in the Institute of Medicine report (http://www.nationalacademies.org/hmd/Reports/2015/Sharing-Clinical-Trial-Data.aspx). We agree that allowing sponsors to use controlled data sharing approaches in which an independent review panel, such as the Yale Open Data Access (YODA) Project (http://yoda.yale.edu), reviews the research proposals, has decision rights, and shares data via a secure platform, is appropriate. Controlled access allows clinical trial sponsors to maintain their commitments to protecting participant privacy, prevents unfair commercial use, minimizes invalid secondary analyses, and assures acknowledgement for clinical trialists and sponsors through data use agreement requirements. We also note that while the proposal talks about “authors” sharing data, in reality, it is the “data holder” who will need to be held accountable for sharing the data. This will require coordination between the authors and data holders to ensure a system and process are in place for data sharing.

    6 Month Time Frame
    • I agree with this general approach
    Comments: We agree with this general approach. We acknowledge, however, that this newly proposed timeline for sharing data may, in some cases, make it difficult for some authors and sponsors to ensure all operational, strategic and scientific tasks are completed, such as adequate time for publication of additional results by investigators. With this in mind, we also support the ICMJE proposal to include a fair exception process to help avoid inadvertently delaying the time frame for the publication of clinical trial results. We believe this acknowledges that, in some rare cases, there may be valid reasons for either delaying data sharing or not being able to share at all.

    Require a Data Sharing Plan
    • I agree with this general approach
    Comments: We agree that sponsors of clinical trial research should proactively plan for data sharing and share that plan prospectively, including identifying any expected impediments to data sharing such as inability to maintain patient privacy/confidentiality. We believe that there should be flexibility in how this is accomplished, but agree that defining the plan prospectively, before starting a study, is important.

    Providing Credit
    • I agree with this general approach
    Comments: We agree that, when possible, data sharing can take place as a collaborative arrangement and generate useful outcomes. Clinical trials and analyses can be complex undertakings, and there is likely to be additional richness and understanding when secondary researchers can communicate with the original investigators and sponsors. We also agree with the need to recognize the contributions of data generators on secondary publications and ensure there is a general process in place to acknowledge the source of the data used for research. There is a great deal of work and cost associated with the conduct of a clinical trial and preparation of data – which we believe should be acknowledged. Suggestions for providing acknowledgement include: (1) requiring data users to reference the original source data via a unique ID number or citation; (2) incorporating credit for data sharing into criteria for career / academic advancement; (3) creating funding incentives based on data sharing to reward and acknowledge those who make data available for secondary research.

    Other Comments: The Janssen Pharmaceutical Companies of Johnson & Johnson are committed to the principles of responsible sharing of clinical trial data and support the proposal of the ICMJE to share the data that underlie the results put forth in peer-reviewed publications with the purpose of advancing science and medicine. We appreciate that this could require changes to culture and operations for sponsors of clinical trial research. This said, we feel there could be significant benefits to society and to public health using the proposed approach.

    Position:
    Comments:

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