Table 3 Key recommendations for applying the GPP3 principles in the Asia-Pacific region

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

• Clinical research that is relevant to patient populations in the Asia-Pacific region should be published in a timely manner, ideally in English, to maximise accessibility.

• All data from phase 2, 3 and 4 studies should be published in a form that is publicly accessible, regardless of outcome.

• To minimise delays in data dissemination; authors should consider making draft manuscripts available via appropriate non-peer-reviewed methods, such as publication via a trial registry, preprint server or a publicly accessible database prior to peer-reviewed publication.

• Clinical researchers based in the Asia-Pacific region are encouraged to expedite presentation of their data at regional conferences and to strive for publication in a peer-reviewed journal.

2. Reporting and publication processes should follow applicable laws (for example, Food and Drug Administration Amendments Act of 2007) and guidelines (for example, ICMJE recommendations and reporting guidelines found on the Enhancing the QUAlity and Transparency Of health Research [EQUATOR] Network).

• All authors should be aware of any relevant local laws that apply to their research, as well as any laws that may apply to their co-authors and other stakeholders, such as study sponsors.

• Translations of key guidelines, such as the ICMJE guidelines, GPP3 and EQUATOR Network checklists should be consulted for clarity, especially by speakers of English as a second language.

• Guideline-issuing bodies are encouraged to expedite translations of guidelines into Asian languages to help educate and improve adherence in the Asia-Pacific region.

3. Journal and congress requirements should be followed, especially ethical guidelines on originality and avoiding redundancy (that is, duplicate publication).

• Journal and congress requirements should be studied in advance of submitting research for publication.

• Encore conference presentations of research previously presented outside of the Asia-Pacific region may be considered for data that are of high regional interest and have not been presented or made readily accessible to local audiences, but care should be taken to ensure that proper approvals and disclosures are made.

• The possibility of an encore presentation at a later date should be raised with all authors at the time of preparing the primary publication.

• If republishing a translated version of a manuscript, appropriate permissions from the copyright holder (journal and/or authors), journal editors and authors must be sought prior to proceeding, and appropriate efforts made to verify the accuracy of any translation [17, 18].

4. Publication planning and development should be a collaboration among all persons involved (for example, clinicians, statisticians, researchers, and publication professionals, including medical writers) and reflect the collaborative nature of research and the range of skills required to conduct, analyze, interpret, and report research findings.

• The publication of Asia-Pacific regional or national data derived from global studies should be planned in advance to limit any delay and ensure timely dissemination of relevant data for patient care in the region.

• Collaboration and engagement between stakeholders within and outside the Asia-Pacific region is encouraged to optimise publication outcomes when additional specialist knowledge or skills to support publication development are required.

5. The rights, roles, requirements, and responsibilities of all contributors (that is, authors and any nonauthor contributors) should be confirmed in writing, ideally at the start of the research and, in all cases, before publication preparation begins.

• The ICMJE and GPP3 guidelines clearly indicate the expectations of authors of medical and scientific manuscripts published in peer-reviewed journals (as noted earlier, translated versions of these documents are available in Asian languages).

• All authors should be made aware of the contribution required to meet all four of the ICMJE criteria before work on a publication begins.

• Sponsors or professional medical writers involved in the publication process should provide authorship agreements in a language that will be readily understood by authors.

• Potential authors should be identified at the outset of developing a publication and participation from all authors throughout the manuscript development process is strongly recommended.

• Authors and study sponsors should consider, develop and proactively communicate processes for managing situations where a proposed author does not meet the ICMJE criteria.

• If a prospective author has not met the ICMJE criteria for authorship, the steps necessary to meet ICMJE authorship criteria should be explained and an opportunity provided to fulfil those criteria.

6. All authors should have access to relevant aggregated study data and other information (for example, the study protocol) required to understand and report research findings.

AND

7. The authors should take responsibility for the way in which research findings are presented and published, be fully involved at all stages of publication and presentation development, and be willing to take public responsibility for all aspects of the work.

• All authors should contribute to the writing of a publication for submission to a peer-reviewed journal in accordance with the ICMJE criteria and approve the final version before submission.

• Informally approaching individual authors in advance of developing a publication to ensure their understanding of their role and responsibilities (ideally by a speaker of their native language) may be helpful.

• An intermediary, such as a medical writer or the study sponsor may assist with collating and incorporating feedback from individuals into a publication to anonymise feedback.

• If an author has no comments during the review process, they should clearly communicate that the publication has been thoroughly reviewed before offering no further comment.

• Study sponsors and professional medical writers may need to develop novel methods of engaging authors that take into account their preferred ways of working to maximise their contribution, while minimising the review burden, for example, using face-to-face meetings or encouraging junior authors to contribute before approaching senior authors.

• Authors should be reminded that by accepting authorship they are jointly responsible for the validity of the research and the integrity/accuracy of the data included in a publication.

• Guest, honorary or gift authorship to authors who do not meet the ICMJE criteria must not be permitted.

• All authors must provide a ‘Substantial contribution to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work,’ if performed under their supervision, in addition to critically reviewing and approving the submission of any resulting manuscript.

• All individuals who qualify for authorship are named as authors of a manuscript, including employees of study sponsors and junior researchers, when they meet the ICMJE criteria.

8. Author lists and contributorship statements should accurately reflect all substantial intellectual contributions to the research, data analyses, and publication or presentation development. Relevant contributions from persons who did not qualify as authors should also be disclosed.

• Defining the scope of the ‘intellectual contribution’ of authors to research may be difficult, but tools are available to guide this decision [19].

• Individual contributorship statements for each author should be made as part of the manuscript and/or cover letter.

• Authors should make use of statement templates regarding contributorship statements, and acknowledgment of funding and medical writing/editing provided, by journals or in the GPP3 publication [2].

• Authors should be named at the time of submission. The author list or order should only be revised under exceptional circumstances during the peer-review process.

9. The role of the sponsor in the design, execution, analysis, reporting, and funding (if applicable) of the research should be fully disclosed in all publications and presentations of the findings. Any involvement by persons or organizations with an interest (financial or nonfinancial) in the findings should also be disclosed.

AND

10. All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication or presentation.

• Transparency regarding any relationships or potential competing interests relating to the research on both an individual and institutional level should always be favoured.

• Conflicts of interest including financial, personal, social or other interests that may be perceived to directly or indirectly influence the conduct of the author with respect to manuscript development should be disclosed when submitting a manuscript to a peer-reviewed journal [6, 17].

• The use of translation or English-language editing services and the source of any funding for using such services should be disclosed.

• Defaulting to authors having no conflicts of interest is not recommended [20].

• Financial compensation for authoring a publication or presentation is discouraged, although authors may be reimbursed for reasonable publication- or presentation-related out-of-pocket expenses, for example, travel, accommodation and congress registration.