Planning the Trial

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

Trial registration numbers should be included on all publications, even if not required by the journal, to facilitate automatic linking to registry information

Some journals encourage pre-registration of protocols as registered reports before data collection

To be considered for publication in ICMJE member journals, clinical trials must be registered in a publicly available clinical trial registry, i.e., any registry that is a primary register for the WHO International Clinical Trials Registry Platform (see www.who.int/clinical-trials-registry-platform)

Authors are responsible for ensuring they have met the requirements of funding and regulatory agencies regarding the reporting of results in clinical trial registries

The clinical trial registration number should be included at the end of the article abstract

Companies should describe their obligations, and those of the authors, to ensure awareness of and adherence to ethical practices in a written agreement before work on a publication begins; this should include agreements regarding confidentiality and any data embargoes

The agreement should:
• Disclose the sponsor’s role in the review of the publication or
presentation (e.g., for medical accuracy, IP protection, or other legal or regulatory review), and provide a reasonable timeline for review to be completed (30 days is the recommended maximum)
• Describe what, if any, editorial and other support may be available for publication development
• Commit authors to take responsibility for the content, accuracy, and completeness of the publication

Authors should avoid entering agreements with sponsors that interfere with their access to the trial data or their ability to analyze, interpret and publish the data independently

The creation of a publication steering committee is recommended for each clinical/research program and for large clinical trials expected to generate multiple peer-reviewed outputs

The criteria for membership should consider the needs and complexities of the research, as well as inclusivity across geographies, demographics, and job roles

The steering committee should be formed before results are available and all members should receive a charter outlining their responsibilities

In the event of a collaborative alliance between two or more organizations, the steering committee should have representation from all alliance partners, unless otherwise specified

Patients, caregivers, and patient advocates may be appropriate members of a steering committee and may serve as consultants, authors or contributors to publications, depending on journal/conference requirements

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

Membership of the steering committee does not automatically confer authorship

Steering committees should meet at least annually and be formally disbanded once all relevant deliverables are complete

A publication working group should be formed by the steering committee, lead author, or publication professional for each publication to ensure appropriate and transparent authorship decisions

Reasonable efforts should be made to include all people who made intellectual contributions to trial design, analysis, and/or data interpretation as authors

The authors should work together to agree the order in which they will be listed; the CRediT system may be useful to build consensus around questions of authorship and byline order. The lead author may settle disputes; however, in cases of equal contributions, deferring to a neutral criterion such as alphabetical or reverse alphabetical order is recommended

Paid employment related to trial conduct, analysis or publication development does not disqualify a person from authorship

All persons who fulfill the authorship criteria according to ICMJE (see below) must be listed, including company-employed authors and contractors, for example, patients and professional medical writers (i.e., there should be no ghost authors or relinquished authors)

Authors should provide their ORCiD number to ensure transparency in their identity

Authorship should be based on:
1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; AND
2. Drafting the work or reviewing it critically for important intellectual content; AND
3. Final approval of the version to be published; AND
4. 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

All individuals who meet the first criterion should have the opportunity to participate in the review, drafting, and final approval of the manuscript

It is the collective responsibility of the authors to determine that all people named as authors meet all four criteria; this is not the role of journal editors

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

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

When a large multi-author group has conducted the work, the group should ideally decide who will be an author before the publication is initiated, and reconfirm prior to submission

The 5-step framework can be followed to determine authorship: establish an authorship working group of core contributors before patient enrolment begins; determine which authorship contributions will be deemed substantial; implement a process to track progress towards substantial contributions; assess the documented contributions to invite those with substantial contributions to be authors; and ensure invited authors meet ICMJE criteria throughout the process

Authors should be identified at an early stage

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

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

Reimbursement of patients, patient advocates and/or steering committee members for their time throughout publication development is permitted

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

Before writing begins, a lead author should be identified who will direct the content development; joint authorship is increasingly common and acceptable if all authors agree

A lead author should be selected, based on their expertise and existing contributions to the intellectual work of the research being reported. This author should meet ICMJE authorship criterion 1

The corresponding author is responsible for overseeing the submission process and managing communications with the journal

The corresponding author takes primary responsibility for communication with the journal during submission, review, and publication but duties may be delegated to one or more co-authors

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

The corresponding author typically ensures that all the journal’s administrative requirements, such as providing details of authorship, ethics committee approval, clinical trial registration documentation, and disclosures of relationships and activities, are properly completed and reported

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

Include a clear and concise description of the role of each author and any listed nonauthor contributors (e.g., statisticians, professional 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 should have a good understanding of publication ethics and current publication guidelines

Professional medical writers should be in frequent contact with the authors during the development of the manuscript

Documentation (e.g., author agreements, meeting minutes, publication drafts, comments and approvals) should be retained in an auditable format, in line with sponsor policies

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

Professional medical writers must follow GPP guidelines and ICMJE recommendations, consult appropriate reporting guidelines (e.g., CONSORT), ensure authors/sponsors are aware of their obligations, and keep up to date with advances in best practice

Sponsors must provide authors and other contributors with full access to all trial information necessary to prepare the publication or presentation as well as to appraise the quality and robustness of the findings (e.g., study protocol, statistical analysis plan, and trial report and relevant anonymized data) before writing begins

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

Authors should agree as to who will perform final checks for data accuracy. Authors should fulfil this responsibility as regards data; a professional medical writer, if not a byline author, should not perform the final data check

Manuscripts submitted to ICMJE journals reporting clinical trial results must contain a data sharing statement

Authors and sponsors should discuss practical issues such as the choice of journal and conferences, with suggestions from publication professionals, but recognize that the authors have the final decision

Open-access or free-to-access options for publications should be used whenever possible and funds for this purpose considered when planning budgets

Pre-submission inquiries to journal editors about specific datasets or publications should only be done with the agreement of the authors

Authors should be aware of predatory or pseudo journals that accept and publish almost all submissions; they may charge article processing fees and claim to perform peer review even if they do not

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

Author lists should remain consistent for a specific dataset, and encore presentations should list the same authors as the original presentation

If a colleague served as an author for a conference presentation and opts out of the byline for a subsequent manuscript, this earlier authorship should be either noted in an acknowledgment or cited

Care must be taken to avoid the appearance of duplicate or redundant publications

Encore publications and translations should be considered only to meet specific scientific needs and/or reach audiences who would otherwise lack access

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

Secondary publication of materials already available in other journals or online may be justifiable when intended to disseminate important information to a wider audience, e.g., guidelines in a different language

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

Each journal publication should be accompanied by a plain language summary (PLS) and should ideally be peer reviewed; review by a lay person, patient or plain language expert may be helpful

A PLS follows plain language principles and may serve many audiences, while lay summaries of publications are intended for nonexperts. A well-designed PLS may serve both functions

Any publication might be augmented by enhanced content, including a PLS or lay summary; these can be in text, video, audio, podcast, or infographic format

Results should be submitted for publication within 18 months of trial end for licensed products; for investigational products, results should be submitted within 12 months of product approval or 18 months of product discontinuation

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

The manuscript should follow established reporting guidelines (e.g., CONSORT for randomized trials, PRISMA for systematic reviews, STROBE for observational trials etc. as found on the EQUATOR network)

Authors should consult guidelines for the reporting of specific trial types, e.g., CONSORT; this helps to describe trials in enough detail for effective evaluation

The authors control and direct the publication content. The professional medical writer must receive direction from the authors before they undertake any writing, including an outline

The authors should be fully involved at all stages of publication and comments should be documented and made available to all authors

If conflicting comments are received, consensus should be reached through discussion with all authors/contributors

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

Authors are responsible for the content, accuracy, and completeness of the publication and its final approval

Once authors are satisfied with the publication draft, the professional medical writer should manage the review and approval process through the sponsor, following applicable processes

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

People with commercial job roles should not be involved in publication review or approval

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

Copyright permissions for the reproduction of previously published materials should be retained in accordance with sponsor policies

Written permission should be obtained from the copyright holder to reproduce any previously published figures or tables; permission is required irrespective of authorship or publisher, except for documents in the public domain

Nonauthor contributors who provided technical expertise, trial investigators or participants (often as a group), should be included in an acknowledgment statement. People who reviewed the publication and provided helpful advice may also be acknowledged

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

The authors will disclose, at a minimum, the professional medical writer’s name, professional qualifications, affiliation, funding source, and any other information required by the journal or conference

Those persons who are acknowledged must provide their written permission, as acknowledgment may imply endorsement of a trial’s data and conclusions

At submission, the journal should require authors to disclose whether they used artificial intelligence (AI)-assisted technologies. Humans are responsible for any submitted material that included the use of AI-assisted technologies

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

Authors should acknowledge professional medical writing support, including its nature; the names, highest relevant qualification, and affiliation of the writer accountable; and the funding source for the writing support

Authors and sponsors should disclose all sources of funding and other sources of support, as well as relevant financial and nonfinancial relationships that could be perceived to bias their work or influence professional judgment

If no time frame for disclosure is specified by the journal or conference, it is recommended to follow the ICMJE disclosure form and use a 36-month disclosure window

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 the trial design, the collection, analysis and interpretation of data, writing the report, and the decision to publish

Perceptions of conflicts of interest are as important as actual conflicts of interest; an author’s complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the process

The ICMJE has developed a Disclosure Form to facilitate and standardize authors’ disclosures

Authors should declare whether they had access to the trial data

Using a contributorship model to describe each person’s role in the development of a publication or presentation is encouraged

Clear, concise descriptions of the roles and affiliation of each author and any listed nonauthor contributors should be included within each publication or presentation

Some journals now request and publish information relating to the contributions of each named participant in the research

Contributors may be acknowledged individually or as part of a group, e.g., Clinical Investigators, as long as their contributions are specified

Urgent public health needs may necessitate the use of pre-prints for clinical trial data in limited circumstances to collect feedback or share critical information

Since pre-prints generally are not peer reviewed, they should not be a routine element of publication planning or data dissemination for company-sponsored trial data

Pre-prints should meet the same standards for rigor, completeness, and ethics as a peer-reviewed publication. All authors must agree to posting on a pre-print server

Pre-print servers should clearly identify pre-prints as not peer reviewed; require author disclosures and funding sources; have clear processes for users concerns; and document pre-print withdrawals and publication in a peer-reviewed journal

It is the authors’ responsibility to ensure that pre-prints are amended to point readers to subsequent, peer-reviewed versions of the work

Pre-prints should be clearly distinguished from peer-reviewed publications, i.e., watermarked, and should clearly disclose the lack of formal peer review in the article

Pre-publication checks of pre-prints should be extensive, using a comprehensive checklist

Articles on pre-print servers that have been subsequently fully published should be marked as such and linked via the DOI to the final published version

Authors should approve the publication version to be submitted and state a commitment to take public responsibility for the work, which may be done via email

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

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 evaluate peer review comments before a professional medical writer undertakes any revisions; if applicable, a sponsor employee should be responsible for obtaining any necessary reviews (e.g., intellectual property) of the updated materials

Substantial revisions as a result of peer-review may warrant the addition of new authors and/or acknowledgments, and should be approached in accordance with journal guidelines

A peer-reviewed journal is under no obligation to follow reviewer recommendations; the journal editor is ultimately responsible for the selection of all content

All reviewer and journal 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)

In the event of rejection comments, authors may consider submitting to a second-choice journal with itemized rebuttals and relevant updates (portable peer-review)

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

Once an article has received final acceptance it may be cited as being “in press”

The authors of articles discussed in correspondence/online journal forums have a responsibility to respond to any substantial criticisms of their work

Social media posts should only be made by appropriate accounts and should not violate embargoes; requests regarding social media posts should be managed by the corresponding author, who should consult/ inform the other authors

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

Many journals embargo content before publication