Information for Contributors

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Instructions for authors

Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors

Editorial Policy

Authorship.

Peer Review and the PJOHNS: Principles, Problems, and Promise

Editorial Policy and Style Information

Editorial Policy and Style Information

Open Researcher and Contributor ID (ORCID) is a community-driven non-profit organization that provides an open registry of persistent identifiers for researchers and scholars. The mission of ORCID is to address the name ambiguity problem in research and scholarly communication. ORCID works with the research community to embed identifiers in research workflows: grant applications, manuscript submissions, association membership renewal, meeting abstract submission, everywhere that a person can be connected with a research or scholarly contribution. This article describes ORCID, and its adoption by the research community, and provides examples of how ORCID identifiers are being integrated by organizations throughout the community and becoming part of the metadata on a diverse set of documents. Ultimately, the goal of ORCID is to improve discoverability, reduce repetitive data entry, and thereby allow researchers and organizations more time to focus on research and scholarly pursuits.

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups. (1) Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers. It is encouraging that data sharing is already occurring in some settings. Over the past year, however, we have learned that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time. Although many issues must be addressed for data sharing to become the norm, we remain committed to this goal. Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals: i) As of July 1, 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below. ii) Clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trials registration. The ICMJE's policy regarding trial registration is explained at www.icmje.org/recommendations/browse/ publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record. Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared; what data in particular will be shared; whether additional, related documents will be available (e.g. study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses and by what mechanism). Illustrative examples of data sharing statements that would meet these requirements are in the Table 1. These initial requirements do not yet mandate data sharing, but investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions. These minimum requirements are intended to move the research enterprise closer to fulfilling our ethical obligation to participants. Some ICMJE member journals already maintain, or may choose to adopt, more stringent requirements for data sharing. Sharing clinical trial data is one step in the process articulated by the World Health Organization (WHO) and other professional organizations as best practice for clinical trials: universal prospective registration; public disclosure of results from all clinical trials (including through journal publication); and data sharing. Although universal compliance with the requirement to prospectively register clinical trials has not yet been achieved and requires continued emphasis, we must work towards fulfilling the other steps of best practice as well-including data sharing. As we move forward into this new norm where data are shared, greater understanding and collaboration among funders, ethics committees, journals, trialists, data analysts, participants, and others will be required. We are currently working with members of the research community to facilitate practical solutions to enable data sharing. …

The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups. (1) Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers. It is encouraging that data sharing is already occurring in some settings. Over the past year, however, we have learned that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time. Although many issues must be addressed for data sharing to become the norm, we remain committed to this goal. Therefore, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in our member journals: i) As of July 1, 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement as described below. ii) Clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trials registration. The ICMJE's policy regarding trial registration is explained at www.icmje.org/recommendations/browse/ publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record. Data sharing statements must indicate the following: whether individual deidentified participant data (including data dictionaries) will be shared; what data in particular will be shared; whether additional, related documents will be available (e.g. study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses and by what mechanism). Illustrative examples of data sharing statements that would meet these requirements are in the Table 1. These initial requirements do not yet mandate data sharing, but investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions. These minimum requirements are intended to move the research enterprise closer to fulfilling our ethical obligation to participants. Some ICMJE member journals already maintain, or may choose to adopt, more stringent requirements for data sharing. Sharing clinical trial data is one step in the process articulated by the World Health Organization (WHO) and other professional organizations as best practice for clinical trials: universal prospective registration; public disclosure of results from all clinical trials (including through journal publication); and data sharing. Although universal compliance with the requirement to prospectively register clinical trials has not yet been achieved and requires continued emphasis, we must work towards fulfilling the other steps of best practice as well-including data sharing. As we move forward into this new norm where data are shared, greater understanding and collaboration among funders, ethics committees, journals, trialists, data analysts, participants, and others will be required. We are currently working with members of the research community to facilitate practical solutions to enable data sharing. …

Prospective Clinical Trial Registration: A Prerequisite for Publishing Your Results.

The reporting of race provides transparency to the representativeness of data and helps inform health care disparities. The International Committee of Medical Journal Editors (ICMJE) developed recommendations to promote quality reporting of race; however, the frequency of reporting continues to be low among most medical journals. To assess the frequency as well as quality of race reporting among publications from high-ranking broad-focused surgical research journals. A literature review and bibliometric analysis was performed examining all human-based primary research articles published in 2019 from 7 surgical journals: JAMA Surgery, Journal of the American College of Surgeons, Annals of Surgery, Surgery, American Journal of Surgery, Journal of Surgical Research, and Journal of Surgical Education. The 5 journals that stated they follow the ICMJE recommendations were analyzed against the 2 journals that did not explicitly claim adherence. Measured study outcomes included race reporting frequency and use of the ICMJE recommendations for quality reporting of race. A total of 2485 publications were included in the study. The mean (SD) frequency of reporting of race and ethnicity in publications of ICMJE vs non-ICMJE journals was 32.8% (8.4) and 32.0% (20.9), respectively (P = .72). Adherence to ICMJE recommendations for reporting race was more frequent in ICMJE journals than non-ICMJE journals (mean [SD] of 73.1% [17.8] vs 37.0% [10.2]; P < .001). The frequency of race and ethnicity reporting among surgical journals is low. A journal's statement of adherence to ICMJE recommendations did not affect the frequency of race and ethnicity reporting; however, there was an increase in the use of ICMJE quality metrics. These findings suggest the need for increased and more standardized reporting of racial and ethnic demographic data among surgical journals.

board, journal staff, and publisher, and as we mark the beginning of a new calendar year, I am pleased to recount the very substantial accomplishments of Anesthesiology over the past year and to look ahead.Our vision and objective is to be the trusted and authoritative source for quality science and credible information in perioperative, critical care, and pain medicine.We place our product, watchword, and aspiration on the cover of every issue: Trusted evidence -discovery to practice.We continuously strive to increase the richness and reach of journal content and provide superior and valued service to our readers and contributors. "Numerous improvements have been made [to Anesthesiology],to aid and enhance the author and reader experience.

From the Editor-in-Chief