Publishing your clinical trial

We were contacted by our client to assist with publishing the results of a phase 1 clinical trial of a novel therapy targeting a virus that is currently listed by the WHO as a high priority pathogen with epidemic potential.

As many of the researchers involved in the study were very busy with non-research work roles and other commitments, publication of this work was delayed.

Our first meeting with the key stakeholders included international and interstate collaborators, senior staff from the Communicable Disease Branch at Queensland Health and the Princess Alexandra Hospital in Brisbane, Queensland, as well as prominent researchers from the University of Queensland, CSIRO, and clinical research organisations.

As the primary for SugarApple Communications, I presented an outline of the workflow, and target dates for the various stages leading up to submission of the manuscript to our target journal.  I also made recommendations regarding data presentation and ensuring that the manuscript conformed to CONSORT guidelines and journal specifications. I also outlined the additional data and methodological details required for manuscript preparation, and identified the groups involved in the study who could provide this.   

The meeting was a success, and the excitement by all stakeholders that this work was back on track for publication was evident. It was exciting for me as well, because several of the lead investigators discussed the project with me after the meeting, and indicated who to contact for specifics about the trial and obtaining the necessary details to proceed with manuscript preparation. The group generally seemed confident that SugarApple Communications had the skills to expedite the publication of this important work.

Following this meeting, we provided authors with written outlines of the process, timelines and target dates for feedback and manuscript revisions. All timelines were adhered to, and the next few weeks saw significant progress with the manuscript.  

We also worked with our client to identify other collaborators who made significant contributions to the project, but who had moved away to another institution or overseas, and had lost contact with the lead investigator. We encouraged existing authors to ensure a more ‘inclusive’ approach to authorship, bearing in mind the journal’s specification of adhering to GPP3 requirements for authorship.  Given the public health importance of this work, we encouraged our client to consider media releases once the work was published.

It was exciting for both our client and us to receive favourable responses and provisional acceptance by the Senior Editor of the journal, and comments back from the reviewers that were able to be easily addressed. We worked with our client to respond to reviewers’ comments, ensuring that all questions were carefully and fully addressed and submitted by the requested deadline. These responses were deemed acceptable by the Senior Editor of the journal, and within weeks of resubmission, our manuscript was accepted for fast-track publication. We also worked with our client through the proofs stages, and assisted with preparing media releases targeted to lay audiences.

As scientists, these are the moments that bring the greatest joy, and are worth celebrating.  For us, the comment from the lead investigator that this clinical trial of considerable public health importance was finally published in a very reputable journal ‘thanks to Sharon’s brilliant work’, was definitely worth celebrating.

It was a pleasure to work with talented researchers in facilitating publication of this landmark study through all stages of the process, from revising the draft manuscript, formatting flow-charts and tables, and ensuring trial data were clearly and accurately presented, to identifying and following up with additional authors who participated in the work but were now at a different institutions, or overseas and in different time zones, or out of contact traveling in Outback Queensland!  We also worked with authors on administrative matters related to publication, such as preparing author contribution statements, conflict of interest forms, and obtaining written consent from individuals included in the Acknowledgements, as required by the journal.

 “I have no doubt we would not have been able to progress without your support, and your involvement helped us to the really good outcome we had. I really appreciated your professionalism and the way you managed to corral all the people involved in the project.”  (SBL, Medical Director, Communicable Disease Branch, Prevention Division, Queensland Health, Brisbane, QLD).

This manuscript is now published in the Lancet Infectious Disease journal.

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