Karen D. Mittleman, PhD; Allison M. Galway, MS, ISMPP CMPP™, Chameleon, a member of Omnicom and Healthcare Consultancy Group, New York, NY, USA; Jason Gardner, PhD, ISMPP CMPP™, CMC Connect, McCann Health Medical Communications, Macclesfield, UK; Lana Vegman, PharmD, ISMPP CMPP™, formerly Retrophin, Inc., San Diego, CA, USA
In June 2017, the International Committee of Medical Journal Editors (ICMJE) advised the research community that all clinical trial manuscripts submitted to ICMJE journals after July 1, 2018 would require a data sharing statement for the manuscript to be considered for publication.¹ Although not all journals are members of ICMJE, this organization often sets the trend for other clinical research journals.
The MAP Working Group and the Global Trends and Transparency Committee undertook a pilot project to assess the potential impact to date of the ICMJE Data Sharing Statement policy. The overall goal of this pilot project was to assess the policy’s impact on the scientific publication community and identify if there are any trends or differences in implementation between various stakeholders. This pilot was conducted through a survey, sent by email and/or through personal interviews between June 2019 and August 2019 – primarily to publication leaders of small/medium/large-sized pharmaceutical companies and biotech companies. The size of a company was categorized by representatives involved in the completion of each survey and was confirmed by each company’s public description on its website. A different set of questions was sent to two publishers.
Below is a summary of key results by responder category. The complete questionnaire is included in the appendix at the end of the article.
Large Pharmaceutical Companies (n=13)
- Nearly all large pharmaceutical companies (12/13; 92%) reported that they have a standard data sharing statement used for multiple transparency purposes (e.g. www.clinicaltrials.gov, publications) and have a formal policy/process for data sharing requests.
- The majority (10/13; 77%) proactively utilized their standard statement when submitting to journals with the remainder more closely following the specific journal guidance.
- Over one-third (5/13; 38%) of the companies reported getting feedback from journals on the statement they used to add more clarity, with one company proactively reaching out to a journal editor to assist in drafting its statement.
- One of the surveyed companies maintained a database of data sharing requirements by key journals; other respondents noted this type of database is unnecessary because of the variability in journal guidelines.
- The stage at which the clinical team was notified about the potential for data sharing based on the publication was split between “publication initiation” and “journal selection,” followed by “initial discussion with authors.”
- When queried about how often a selected journal requested a data sharing statement, responses were evenly distributed between “often,” “rarely,” or “never,” with the latter clarified by the fact that it was proactively provided in the submitted manuscript.
- Most companies provide their data sharing statement at the time of submission of the manuscript.
- Approximately half of the respondents (6/13; 46%) reported receiving data requests triggered by their published data sharing statements.
Medium/Small-Sized Pharmaceutical Companies (n=8)
- A standard data sharing statement for multiple transparency uses was identified by 6/8 (75%) of the medium/small-sized pharmaceutical companies, with 5/8 (63%) having a formal policy/process in place for data sharing requests. One company noted it does not share data.
- The majority (6/8; 75%) proactively use their standard statement when submitting to journals; none of the companies reported receiving feedback when a statement was provided.
- One company maintained a database of journal data sharing requirements.
- When queried about how often a data sharing statement has been requested by a journal, the medium- and small-sized companies were approximately evenly split answering “often” or “never.”
- The stage at which the company’s clinical team was notified about the potential for data sharing based on the publication was more often “at start of study” followed by “after database lock.”
- None of the companies reported receiving data requests based on the data sharing statement in the publication.
Biotech Companies (n=4)
- Half of the biotech companies surveyed (2/4; 50%) reported they have a formal policy/process in place for data sharing requests, use a standard data sharing statement for multiple transparency purposes, and proactively use this statement when submitting manuscripts.
- None of the companies reported having feedback from the journals on their data sharing statements, and no databases were used to maintain data sharing requirements.
- Each company selected a different stage of research at which the clinical team was notified of the data sharing requirement with journals.
- One company received a data sharing request based on a publication.
- Although the majority (3/4; 75%) indicated they “rarely” received a request from the journal to provide a data sharing statement, they all indicated that when a request was received, it occurred upon manuscript submission.
Publishers (n=2)
- The two publishers surveyed stated that they encourage the use of a data sharing statement for all their journals, but it is not compulsory.
- For one of the publishers, a select group of journals require mandatory data sharing, as well as peer review of the shared data. The journal editors would ensure requests for data sharing are referred to the authors.
- Although the publishers indicated that manuscripts could be accepted without a data sharing statement and that the decision would not be affected by the inclusion of a statement, this would be journal specific.
Summary
This pilot survey indicates there are variations in the way that different stakeholder organizations are implementing the ICMJE Data Sharing Statement policy, as well as policies of specific journals, although there is some consistency within large and medium/small pharmaceutical companies. While the number of biotech companies surveyed was not large, there was greater variability among them. What seems universal is the acknowledgement that relatively few requests for data were received based on publications and their associated data sharing statements.
There is no doubt that all stakeholders in scientific publications share the ICMJE belief that “there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk.”¹ This pilot survey noted differences in stakeholders’ implementation and experiences of the ICMJE Data Sharing Statement policy, but it was encouraging to see that the majority of large- to small-sized pharmaceutical companies have a standard data sharing statement in use. In order to realize the goal of making data sharing the norm, it is the responsibility of medical publication professionals to continue driving the adoption of such practices through leadership and best practice approaches.
Reference
¹Taichman DB, Sahni P, Pinborg A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Ann Intern Med. 2017 Jul 4;167(1):63-65. doi: 10.7326/M17-1028. Epub 2017 Jun 6.
Appendix
| Survey Questions for Pharma Companies | Survey for Publishers |
| 1) Does your company use a standard data sharing statement for all transparency activities (ie, CT.gov, publications, data sharing commitments)?
2) Have you received any feedback from journal editors in regards to your company’s data sharing statement? 3) Do you most often get asked to provide your data sharing statement to the journals, or do the journals typically have a template of data sharing statement options for you to choose from that would most closely fit your company’s policy/practice? 4) Does your company maintain a database of journals’ data sharing requirements? 5) Does your company have a formal process and/or SOP in place for sharing data when requested? 6) At what stage of research do you work with your clinical team on awareness of data sharing for publications? (Circle or highlight best answer) a. At start of study 7) Have you received any requests for sharing data based on a statement in the publication? 8) In the past year, how often have you received a request from the journal to provide a data sharing statement with a manuscript submission? (Circle or highlight best answer) a. Always 9) If asked to provide a data sharing statement, is it requested by the journal at: (Circle or highlight best answer) a. Submission Any additional comments you would like to make, please do so here: |
1) Do you use a standard data sharing statement for all journals you publish?
2) Do your journals accept publications that do not state they will share study data? 3) What role do your journals play if data sharing is requested? 4) What weight does the pharma company’s data sharing statement or policy have on your decision whether to accept/publish the manuscript?
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