Publication and Authorship Policy for F2G Sponsored Clinical and Non-Clinical Research

1. PURPOSE AND SCOPE

   The purpose of this Policy is to lay out the criteria for deciding authorship of clinical and non-clinical research which has been organised and funded by F2G (i.e. where F2G is the sponsor of the study and takes legal and regulatory responsibility) as well as decisions on which journals to submit research papers to. It also establishes the framework for publication of research with both a positive and negative outcome as well as defining criteria for any payments which may be made and to whom.

2. DEFINITIONS

   Author:

   A clinician, scientist or investigator of research who has been engaged in F2G-sponsored research and who meets the criteria defined in section 3.9

   Principal investigator/principal scientist:

   Senior investigator/scientist who meets all the criteria in section 3.9 and who takes overall responsibility for the study integrity and who acts as corresponding author for the paper(s)

   DSMB:

   Data Safety Monitoring Board

   DRC:

   Data Review Committee

   ICMJE:

   International Committee of Medical Journal Editors

3. POLICY
   1. This policy applies to non-clinical and clinical studies which have been organised and sponsored by F2G.
   2. Studies for which F2G has provided drug or funding (otherwise known as investigator sponsored research) only, and for which F2G is not otherwise responsible, are not covered by this policy and are covered in a separate policy.
   3. This policy applies to print and digital articles which are to be published in peer-reviewed journals as well as abstracts, posters and oral and digital presentations for academic and scientific congresses whether or not peer review is required.
   4. The policy must be agreed by all parties, wherever possible, before embarking on any study.
   5. Data should be presented or published in a timely manner, although F2G reserves the right to delay publication or presentation if there is an issue relating to protecting intellectual property rights.
   6. F2G retains the right to review all articles referring to olorofim and generated from sponsored studies.
   7. All articles should be submitted to F2G for review at least 8 weeks prior to submission to the target journal.
   8. F2G adheres to the recommendations from the International Committee of Medical Journal Editors on the publication of clinical papers http://icmje.org/recommendations/¹
   9. Potential authors must meet the four criteria laid down by the ICMJE¹:

      Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND

      Drafting the work or revising it critically for important intellectual content; AND

      Final approval of the version to be published; AND

      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. In addition to being accountable for the parts of the work he or she has done, an author should be able to identify which co-authors are responsible for specific other parts of the work. In addition, authors should have confidence in the integrity of the contributions of their co-authors

      In addition, authors will be asked to complete the Credit form (see 3.22)
   10. Depending on the nature of the paper (e.g. non-clinical, early clinical or late clinical) F2G staff (including, but not limited to, the Chief Scientific and Development Officer or the Chief Medical Officer, respectively, Global Head of Medical Affairs and appropriate department head), in consultation with the principal investigator/lead scientist and other key advisors, will agree which advisors, investigators and F2G staff meet the criteria in 3.9 and should be offered authorship.
   11. The same team will determine the target journal.
   12. F2G will not pay potential authors for their time in conducting data analysis, writing or reviewing the paper.
   13. F2G will provide statistical support for clinical studies where it is the sponsor.
   14. F2G may provide medical writing support for authors and will provide funding for such support as necessary. Such support will be publicly disclosed.
   15. Any editorial rules required by journals will be adhered to.
   16. The corresponding author for any pivotal paper who liaises with other authors and with the journal is typically the principal investigator (PI), or lead scientist for non-clinical papers, unless otherwise agreed in advance with F2G.
   17. F2G will provide administrative support to the PI to ensure all necessary documentation is available for submission to the journal as required.
   18. All named authors should be willing and able to present the data at any international or regional meetings, respond to questions on the study design and implementation and to defend the study, and any paper(s) originating from the study, in case of criticism.
   19. First authorship is highly sought after. Any first authors must meet all four criteria listed in section 3.9, should have a high credit² score for authorship, and should not hold any additional responsibility (e.g., member of Data Safety Monitoring Board [DSMB], member of Data Review Committee [DRC]) for the study. Additional criteria, over and above those listed in section 3.9, for first author, may also include high rate of recruitment into the study, timely and accurate recording of patient data into the CRF, and there should be no major or critical audit findings at the study site of any proposed first author. The first author should make a significant contribution to writing and reviewing the paper. Additional criteria for first authorship may be discussed and agreed by F2G staff and the PI. The same criteria will apply to second and third authors. Top recruiting sites are likely to be audited during the study either by F2G or its agents.
   20. The decision on who will be first author will be made prior to starting to write the key papers and ideally prior to any study analyses being performed.
   21. F2G seeks to support the development of new investigators and researchers and will seek to provide opportunities for authorship to less experienced persons where possible if they meet all the required criteria.
   22. All authors or potential authors must be able to clearly document their role in the study as defined in section 3.9 by completing the Credit² form (Appendix 1).
   23. Generally, no single investigator or researcher will be first author on more than one paper arising from a single clinical trial/non-clinical study. The last author, unless the PI, will also vary across the key papers.
   24. Members of the DRC may be named authors on the pivotal clinical paper if they meet all the criteria defined in section 3.9.
   25. In line with the EMA’s Guidance on the Role of Data Monitoring Committees³ (EMEA/CHMP/EWP/5872/03 Corr; 2005), the chair and members of the Data Monitoring Committee or DSMB will not be named authors on any pivotal papers as this presents a conflict of interest, with the exception of any planned safety analyses and publications.
   26. All clinical investigators and sites which have screened or enrolled subjects will be acknowledged as contributors in the pivotal paper. Generally, those who have not enrolled a patient will not be considered as named authors unless they meet other criteria defined in 3.22.
   27. All members of study expert committees (e.g., DRC, DSMB) will be acknowledged in the pivotal paper.
   28. The publication plan policy will be shared with all study sites at the initiation of the study and once more when site files are closed.
   29. Negative or ‘failed’ studies will still be offered for publication in a peer reviewed journal with the aim of sharing key learnings on study design with investigators and researchers.
   30. Individual case studies of subjects enrolled in F2G-sponsored trials will be considered on their merits. The decision to present at conferences or to publish case studies will be made between the principal investigator of the site and the F2G Chief Medical Officer and Global Head of Medical Affairs. Case studies will not be approved if their publication jeopardises the overall analysis and publication of the clinical trial.
   31. The investigator must gain Ethics approval to present or publish a case study and the patient concerned must provide written permission for their medical details to be published.
   32. F2G adheres to all rules to protect subject privacy and confidentiality.
   33. Requests for access to data for external analysis may be considered only after completion of internal analyses and publication of primary data. Requests should be submitted via the F2G website. F2G retains the intellectual property rights for all data relating to clinical and non-clinical trials where it is the sponsor and as such will make the final decision on release of data.
   34. F2G will carefully review any request from a journal for access to protocols other than those requiring registration in a database of privately and publicly funded clinical studies e.g. clinicaltrials.gov) or other data not in the public domain, subject to maintaining intellectual property rights and maintenance of subject confidentiality.
   35. It is the policy that all papers emanating from non-clinical and clinical research shall be open access. When submissions are made by third party collaborators, F2G shall commit to pay the publication fees directly to the publisher, associated with this requirement.
4. REFERENCES

1. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals. http://icmje.org/recommendations/ December 2018
2. Allen L, Brand A, Scott J, Altman M and Hlava M. Credit where credit is due. Nature; Vol 508: 17 APRIL 2014
3. Guidance on the Role of Data Monitoring Committees. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf; accessed 19 November

Appendix 1. Credit form