Planning the trial

1/26

Clinical trials in human subjects should be approved by an Institutional Review Board or an Independent Ethics Committee

Clinical trials in human subjects should follow the Declaration of Helsinki (see www.wma.net)

Clinical trials in animals should follow institutional and national guidelines for the care and use of laboratory animals

Protocols for randomized controlled trials should follow the SPIRIT guidelines

The sponsor should develop publication plans using a cross-functional publications team

Commercial functions should not direct publication planning



Clinical trial registration

2/26

Trial registration is required by many national and international guidelines and laws and is required by many journals

Clinical trial registration numbers should be included on all publications even if this is not required by the journal

Unregistered trials should be declared as such, and the reason for nonregistration provided

In order to be considered for publication in ICMJE member journals, clinical trials must be registered in a publicly available clinical trial registry



Publication agreement

3/26

Companies should provide authors with a copy of their publication policy on request

Companies should describe their obligations, and those of the authors, to ensure ethical practices in a written agreement before work on a publication begins

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

The agreement should describe the publication process including the role the sponsors will have in reviewing the publication (if any)

The agreement should describe what, if any, editorial and other support may be available for publication development

Sponsors should advise authors of any financial reporting requirements relevant to providing editorial and other support

The agreement should commit authors to take responsibility for the content, accuracy, and completeness of the publication

The agreement should confim the authors’ freedom to publish study results without hindrance from the sponsor



Steering committee / writing group

4/26

A publication steering committee may be formed to plan and oversee the development of publications

The committee should be formed before results are available

All investigators should be informed of the committee’s membership and its responsibilities

Membership of the steering committee does not automatically confer authorship

For studies involving many investigators, a writing group should be set up



Authors

5/26

An authorship working group should be formed by the publication steering committee to ensure appropriate and transparent authorship decisions

The authors should work together to agree the order in which they will be listed

Authorship criteria should be applied consistently

All authors listed on a publication must fulfill the authorship criteria (i.e., there should be no guest authors)

All persons who fulfill the authorship criteria must be listed, including company-employed authors and contractors (i.e., there should be no ghost authors)

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

Authorship must not be used as a reward or gift for services rendered

Authorship should be based on:

  • substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data
  • drafting or revising the work critically for important intellectual content
  • final approval of the version to be published
  • agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved

Authors should be accountable for their own work and be able to identify which co-authors are responsible for other

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

Authors should be identified at an early stage



Author payment

6/26

Companies may reimburse reasonable out-of-pocket, publication-related expenses (e.g., travel and accommodation)

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

Payment should never be made (or offered) simply to attract someone to be an author or influence an author’s opinion



Corresponding author

7/26

The author group should identify a corresponding author who will be responsible for communicating with the journal

One author should function as the primary contact between the journal and the other authors (= corresponding author)

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

The corresponding author takes primary responsibility for communication with the journal during submission, review, and publication

The corresponding author should be available to respond to editorial queries in a timely way



Lead author

8/26

Before writing begins, the author group should identify a lead author who will direct the content development

The lead and corresponding author may, but do not have to, be the same person



Contributors

9/26

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

Contributors to an article may include, but are not limited to, individuals who provided purely technical help, writing assistance, or general support



Professional medical writers

10/26

A professional medical writer facilitates the development of articles

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

Professional medical writers are considered to be legitimate contributors to articles

All authors must agree to the involvement of a medical writer

Writers should be in frequent contact with the authors during the development of the manuscript

Medical writers should have a good understanding of publication ethics and current publication guidelines



Study data

11/26

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

Sponsors must provide authors and other contributors with full access to relevant aggregated study data before work on a publication begins

Authors and sponsors should establish a process based on honest scientific debate to resolve differences in interpretation of findings or data presentation



Journal selection

12/26

Authors and sponsors should discuss practical issues such as the choice of journal and recognize that the authors have the final decision

The journal choice should reflect the most appropriate means of disseminating the study findings to the target audience

It may be appropriate to approach a journal with a pre-submission inquiry to determine if the research is suitable for publication



Primary and secondary publications

13/26

So long as certain criteria are met, it is acceptable to publish primary and secondary articles from a single clinical trial

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

Primary publications should be published before any secondary publications

Secondary publications should always reference the primary publication and be clearly identified as secondary publications

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

The primary article should always be accepted for publication before other articles reporting secondary endpoints

Secondary analyses should cite any primary publication and clearly state that they contain secondary analyses



Redundant publication

14/26

Sponsors and authors should avoid redundant publication

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

Reuse of material from the authors’ previous publications should generally be avoided but exceptions may include descriptions of methods or data sources

Secondary publications should avoid redundancy and unjustified splitting of study findings across several publications

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



Reporting standards

15/26

The design and results of all clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner

Publications should follow established reporting standards for specific study types (e.g., those found on the EQUATOR Network)

Articles should be considered for publication in the scientific literature regardless of whether the results are positive or negative

The article should follow established reporting guidelines (e.g., CONSORT, PRISMA, STROBE etc.)

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)



Outline of content

16/26

Writers must receive direction from the authors at the earliest possible stage (e.g., before the outline is prepared)



Subsequent drafts

17/26

The authors should be fully involved at all stages of publication

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

Authors should have sufficient time to comment on the drafts of an article



Final draft

18/26

Authors are responsible for all final decisions on publication content and for final approval of the version for submission

Nonauthor contributors should not be expected to approve the final manuscript but a courtesy copy may be provided before submission

Commercial functions should not be involved in publication review or approval



Figures and tables

19/26

Permission should be obtained from the copyright holder to reproduce any previously published figures or tables

Copyright of published content may be held by the publisher, so authors may need permission to reuse their own work



Acknowledgments

20/26

Ensure that all meaningful contributions to the research and publication by individuals and organizations are acknowledged

Each person named in the Acknowledgments should review the wording and provide written permission to be included

Those persons who are acknowledged must provide their written permission

The precise role and affiliations of professional medical writers must be disclosed

Vague acknowledgment of a professional medical writer’s role (e.g., for providing ‘editorial assistance’) must be avoided



Conflicts of interest

21/26

Authors and sponsors should disclose relevant financial and nonfinancial relationships that could be perceived to bias their work or influence professional judgment

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



Disclosures

22/26

Authors and sponsors should disclose all sources of funding and other types of support for the study

If a medical writer helps to develop a publication, the authors should disclose the writer’s name, professional qualifications, affiliation, and funding source

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)

Any involvement by persons or organizations with an interest in the findings (financial or nonfinancial) should be disclosed

Authors should declare whether they had access to the study data



Journal submission

23/26

Articles should comply with the target journal’s requirements regarding:

  • format, style, language, length/word limit, graphic sizes, document format etc.
  • cover letters
  • copyright transfer forms/license agreements, and/or disclosures

Authors should not submit the same manuscript, in the same or different languages, simultaneously to more than one journal

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



Responding to peer reviewers’ comments

24/26

All reviewer and editor comments should be addressed before the article is re-submitted

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)

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)

Authors should approve the version to be published



Acceptance / rejection

25/26

Once an article has received final acceptance, it may be cited as being ‘in press’.

It is worthwhile addressing the suggestions of the peer reviewers if the article is rejected but will be re-submitted to a different journal.



Embargoes

Many journals embargo content before publication

Authors and sponsors should work together to avoid premature release of study information

Embargoes must be respected, e.g., authors, sponsors and institutions should not issue press releases about accepted articles without consulting the journal




Publication

26/26

Congratulations!

Your research paper has been published