Episode 15 - Transforming Clinical Data into a Peer-Reviewed Article (Part 1)

On this episode of the BOEI Podcast, we hear expert advice on how to develop a successful clinical manuscript for peer review from Prof. Dr. Stephanie Joachim, who is Head of Experimental Eye Research at Rurh University in Buchum. Dr. Joachim is highly published and serves as an editorial board member on several scientific journals, in addition to her clinical work and translational research. She is joined by Clotilde Jumelle, who is a Regulatory Project Manager and part of our Clinical Writing Team at Medevise, and Kristine Morrill as moderator for this in-depth conversation.

Speakers:

• Kristine Morrill, Founder and President of Medevise Consulting

• Prof. Dr. Stephanie Joachim, Head of Experimental Eye Research at Rurh University

• Clotilde Jumelle, Regulatory Project Manager at Medevise Consulting

Key Takeaways:

1. Confirm your initial research question. Go to PubMed or Google Scholar and look at recent publications. What is the new and innovative part of your study? Check to ensure you have all the data you need to validate your thesis, and tell the story that you want to tell.

2. Make a timeline. Consider any deadlines from the publication or sponsor. Factor in time for writing, revising, review by core authors, approvals, etc.

3. Have the tools you need: Writing software like MS Word; citation software; statistics program; graphics program for images.

4. What kind of manuscript will you write? A classic full-length article for a clinical or experimental study? A study protocol? Other options include a brief report, case study/report, letter, or review article.

5. Decide on the journal you want to submit to. Consider who the audience is so you can tailor the terminology and language you use to that audience. Be sure that your project is a good fit for the journal. Look closely at the author guidelines, and follow them exactly. Important to note: Submit only to one journal at a time.

6. Confirm the authors, their expectations for the paper, and the order they will be listed. Don’t forget to note additional collaborators.

7. Start writing! Prof. Dr. Joachim recommends working in the following order:

   • Method

     • Describe the experiments you did or which examinations you performed

     • Provide information about the equipment and the materials you used, with city/country noted

     • What kind of statistical analysis you did

     • Include your approval numbers of the ethics committee

   • Results

     • Provide figures, graphs, table to summarize your data. Mark what is significant, and make sure to include lables

     • Provide the precise P values

     • Explain what can be seen in the graph and if there was a significant difference or not

   • Introduction

     • In the last paragraph, repeat your research question and give brief information about your project.

     • Note one major finding to interest the reader in your publication.

   • Discussion

     • This is your opportunity to provide some interpretation and sell your results.

     • Note your findings and how they relate to other projects in the field. Consider addressing any limitations of your studies, whether you used the right methods, recommendations for follow-up experiments, how the project could be continued, or if it is clinically relevant whether current treatments should be changed because of your findings.

     • Discuss other similar studies, and the differences between them and your study.

     • Use precise language

     • Short conclusion

     • Strike the important balance between being humble about your experiments and not exaggerating your findings, while also stating how your results can be helpful for understanding the disease or for future treatment of patients.

   • Title

     • Make it catchy to grab the attention of the reviewer, editor and readers.

     • Short and concise as possible, while also being relevant and informative - perhaps note the main finding

   • Abstract (follow the journal requirements closely)

     • Quick problem statement

     • Research questions

     • Outcome measure used?

     • What method was used?

     • Results

     • Short conclusion

     • It’s important that readers can understand the abstract without reading the article

   • Acknowledgements - don’t forget to include:

     • People that are not authors but provided maybe a cell line or they recruited a few of the patients

     • People who provided help with analysis

     • Technician(s)

     • Funding agencies including grant number (and additional funding support from your dept., etc.), and where the funding went to (for larger projects).

   • Proofreading

   • Cover Letter - addressed to the editor, note who wrote the publication, the name of the manuscript, where you want to submit it, short project summary, confirm this is a original submission, note that all co-authors have read the paper and approve the final version. You can also include reviewer suggestions.

8. Submit! Keep in mind this all takes quite a long time. It may be possible that your publication is rejected. If so, you may receive long letter with questions and suggestions for things to change and revise. Try not to feel too frustrated, and don’t give up. If you have a good project and you do the revisions, or simply submit to a different journal, you will have your work published in the end.