A step-by-step guide to good practice
Clinical trials in human subjects should be approved by an Institutional Review Board or an Independent Ethics Committee
IFPMA/EFPIA/JPMA/PhRMA
Clinical trials in human subjects should follow the Declaration of Helsinki (see www.wma.net)
ICMJE
Clinical trials in animals should follow institutional and national guidelines for the care and use of laboratory animals
ICMJE
Protocols for randomized controlled trials should follow the SPIRIT guidelines
EQUATOR
The sponsor should develop publication plans using a cross-functional publications team
GPP3
Commercial functions should not direct publication planning
GPP3
Trial registration is required by many national and international guidelines and laws and is required by many journals
GPP3
Clinical trial registration numbers should be included on all publications even if this is not required by the journal
GPP3
Unregistered trials should be declared as such, and the reason for nonregistration provided
GPP3
In order to be considered for publication in ICMJE member journals, clinical trials must be registered in a publicly available clinical trial registry
ICMJE
Companies should provide authors with a copy of their publication policy on request
GPP3
Companies should describe their obligations, and those of the authors, to ensure ethical practices in a written agreement before work on a publication begins
GPP3
The agreement should commit authors and sponsors to work together to ensure that publications are complete, accurate, balanced, transparent, and produced in a responsible and timely manner
GPP3
The agreement should describe the publication process including the role the sponsors will have in reviewing the publication (if any)
GPP3
The agreement should describe what, if any, editorial and other support may be available for publication development
GPP3
Sponsors should advise authors of any financial reporting requirements relevant to providing editorial and other support
GPP3
The agreement should commit authors to take responsibility for the content, accuracy, and completeness of the publication
GPP3
The agreement should confim the authors’ freedom to publish study results without hindrance from the sponsor
GPP3
A publication steering committee may be formed to plan and oversee the development of publications
GPP3
The committee should be formed before results are available
GPP3
All investigators should be informed of the committee’s membership and its responsibilities
GPP3
Membership of the steering committee does not automatically confer authorship
GPP3
For studies involving many investigators, a writing group should be set up
EMWA
An authorship working group should be formed by the publication steering committee to ensure appropriate and transparent authorship decisions
GPP3
The authors should work together to agree the order in which they will be listed
GPP3
Authorship criteria should be applied consistently
GPP3
All authors listed on a publication must fulfill the authorship criteria (i.e., there should be no guest authors)
GPP3
All persons who fulfill the authorship criteria must be listed, including company-employed authors and contractors (i.e., there should be no ghost authors)
GPP3
Authorship must represent a substantial intellectual contribution to both the research being reported and the development of the publication and a willingness to take public responsibility for these
GPP3
Authorship must not be used as a reward or gift for services rendered
GPP3
Authorship should be based on:
ICMJE
Authors should be accountable for their own work and be able to identify which co-authors are responsible for other
ICMJE
Authors should be able to take public responsibility for the work and should have confidence in the accuracy and integrity of the contributions of their co-authors
ICMJE
Authors should be identified at an early stage
EMWA
Companies may reimburse reasonable out-of-pocket, publication-related expenses (e.g., travel and accommodation)
GPP3
Companies may pay for publication activities (e.g., statistical analysis, medical writing, editing), any payments should reflect the services provided and be at fair market value
GPP3
Payment should never be made (or offered) simply to attract someone to be an author or influence an author’s opinion
GPP3
The author group should identify a corresponding author who will be responsible for communicating with the journal
GPP3
One author should function as the primary contact between the journal and the other authors (= corresponding author)
MPIP
The corresponding author does not need to be the lead author, but should be selected for their ability to help coordinate the review and revision process
MPIP
The corresponding author takes primary responsibility for communication with the journal during submission, review, and publication
ICMJE
The corresponding author should be available to respond to editorial queries in a timely way
ICMJE
Before writing begins, the author group should identify a lead author who will direct the content development
GPP3
The lead and corresponding author may, but do not have to, be the same person
GPP3
Include a clear and concise description of the role of each author and any listed nonauthor contributors (e.g., statisticians, medical writers, and research personnel) in the publication even if not required by the journal
GPP3
Contributors to an article may include, but are not limited to, individuals who provided purely technical help, writing assistance, or general support
ICMJE
A professional medical writer facilitates the development of articles
EMWA
Unless they have made a substantial contribution to the analysis or interpretation of the data and feel able to take public responsibility for the work, professional medical writers generally do not meet authorship criteria
EMWA
Professional medical writers are considered to be legitimate contributors to articles
WAME
All authors must agree to the involvement of a medical writer
GPP3
Writers should be in frequent contact with the authors during the development of the manuscript
GPP3
Medical writers should have a good understanding of publication ethics and current publication guidelines
GPP3
Sponsors must provide authors with access to all the information necessary to prepare the publication (e.g., protocol, statistical analysis plan, study report) and should allow relevant access to anonymized patient-level data
GPP3
Sponsors must provide authors and other contributors with full access to relevant aggregated study data before work on a publication begins
GPP3
Authors and sponsors should establish a process based on honest scientific debate to resolve differences in interpretation of findings or data presentation
GPP3
Authors and sponsors should discuss practical issues such as the choice of journal and recognize that the authors have the final decision
GPP3
The journal choice should reflect the most appropriate means of disseminating the study findings to the target audience
MPIP
It may be appropriate to approach a journal with a pre-submission inquiry to determine if the research is suitable for publication
MPIP
So long as certain criteria are met, it is acceptable to publish primary and secondary articles from a single clinical trial
IFPMA/EFPIA/JPMA/PhRMA
A primary publication is the first full report in a peer-reviewed journal of the primary outcomes of a study; secondary publications are additional reports of secondary or exploratory objectives, subgroup analyses, or post hoc analyses
GPP3
Primary publications should be published before any secondary publications
GPP3
Secondary publications should always reference the primary publication and be clearly identified as secondary publications
GPP3
One or more authors of the primary publication of a study should contribute to any secondary publications to ensure appropriate understanding and interpretation of the original study
GPP3
The primary article should always be accepted for publication before other articles reporting secondary endpoints
MPIP
Secondary analyses should cite any primary publication and clearly state that they contain secondary analyses
ICMJE
Sponsors and authors should avoid redundant publication
GPP3
Specific findings from a particular study should not be published in more than one journal unless they are reanalyzed or translated, the primary publication is clearly acknowledged, permission is obtained from the publishers, and copyright laws are upheld
GPP3
Reuse of material from the authors’ previous publications should generally be avoided but exceptions may include descriptions of methods or data sources
GPP3
Secondary publications should avoid redundancy and unjustified splitting of study findings across several publications
GPP3
Editors of different journals may agree to publish the same article jointly if they consider this is in the best interest of public health, such publications should include a statement making this clear to readers
ICMJE
The design and results of all clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner
GPP3
Publications should follow established reporting standards for specific study types (e.g., those found on the EQUATOR Network)
GPP3
Articles should be considered for publication in the scientific literature regardless of whether the results are positive or negative
IFPMA/EFPIA/JPMA/PhRMA
The article should follow established reporting guidelines (e.g., CONSORT, PRISMA, STROBE etc.)
EQUATOR
Results should be submitted for publication within 18 months of the study end (for licensed products) or the date of licensing/discontinuation (for investigational products)
IFPMA/EFPIA/JPMA/PhRMA
Writers must receive direction from the authors at the earliest possible stage (e.g., before the outline is prepared)
GPP3
The authors should be fully involved at all stages of publication
GPP3
The sponsor should have the right to review drafts in a timely manner to ensure accuracy, adherence to regulatory requirements, and protection of intellectual property
GPP3
Authors should have sufficient time to comment on the drafts of an article
EMWA
Authors are responsible for all final decisions on publication content and for final approval of the version for submission
GPP3
Nonauthor contributors should not be expected to approve the final manuscript but a courtesy copy may be provided before submission
GPP3
Commercial functions should not be involved in publication review or approval
GPP3
Permission should be obtained from the copyright holder to reproduce any previously published figures or tables
ICMJE
Copyright of published content may be held by the publisher, so authors may need permission to reuse their own work
GPP3
Ensure that all meaningful contributions to the research and publication by individuals and organizations are acknowledged
GPP3
Each person named in the Acknowledgments should review the wording and provide written permission to be included
GPP3
Those persons who are acknowledged must provide their written permission
ICMJE
The precise role and affiliations of professional medical writers must be disclosed
WAME
Vague acknowledgment of a professional medical writer’s role (e.g., for providing ‘editorial assistance’) must be avoided
EMWA
Authors and sponsors should disclose relevant financial and nonfinancial relationships that could be perceived to bias their work or influence professional judgment
GPP3
Articles should be published with statements declaring authors’ conflicts of interest and sources of support for the work and details of the role of the sponsor in study design, collection, analysis and interpretation of data, writing the report, and decision to publish
ICMJE
Authors and sponsors should disclose all sources of funding and other types of support for the study
GPP3
If a medical writer helps to develop a publication, the authors should disclose the writer’s name, professional qualifications, affiliation, and funding source
GPP3
The role (if any) of the sponsor in the research and publication should always be clearly disclosed (e.g., involvement in study design, data collection or analysis, writing support, manuscript review)
GPP3
Any involvement by persons or organizations with an interest in the findings (financial or nonfinancial) should be disclosed
GPP3
Authors should declare whether they had access to the study data
ICMJE
Articles should comply with the target journal’s requirements regarding:
MPIP
Authors should not submit the same manuscript, in the same or different languages, simultaneously to more than one journal
ICMJE
If the corresponding author agrees, and the journal allows this, a medical writer (or appropriate delegate) may complete the administrative tasks associated with submitting the publication to the journal
GPP3
All reviewer and editor comments should be addressed before the article is re-submitted
MPIP
The journal editor should be advised if it is not possible to meet the original deadline for responding to reviewers’ comments (e.g., if extra analysis is required)
GRP
The corresponding author should act as a point of contact between the journal and the other authors and should keep co-authors informed and involve them in decisions about the publication (e.g., responding to reviewers’ comments)
WCRI
Authors should approve the version to be published
GPP3
Once an article has received final acceptance, it may be cited as being ‘in press’.
GRP
It is worthwhile addressing the suggestions of the peer reviewers if the article is rejected but will be re-submitted to a different journal.
MPIP
Many journals embargo content before publication
ICMJE
Authors and sponsors should work together to avoid premature release of study information
GPP3
Embargoes must be respected, e.g., authors, sponsors and institutions should not issue press releases about accepted articles without consulting the journal
GPP3
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