Top tips on Writing Manuscripts from Clinical Trials

July 19, 2019

There are numerous factors which go into producing a successful manuscript, all of which are key to ensuring that the manuscript is not only published but read, after all if no one reads your work then there is little use in it being published.

Select an Appropriate Journal

  • Do your research: which journals have published data similar to yours?

  • Review your target journal’s “instructions to authors”: this is where journals usually state their intended focus.

  • Be realistic: choose a journal which has an appropriate impact factor.

Use an Engaging Title and Writing Style

Recent studies have demonstrated that manuscripts with succinct, declarative titles are much more likely to be circulated outside of academia (1, 2). An accessible style of writing opens up your manuscript to laypeople and is in alignment with the move towards increased layperson accessibility in the new Clinical Trial Regulation (EU) No 536/2014 (3).

Organisation and Formatting

Scientific manuscripts are set out in a logical format which is defined in the journal’s “instructions to authors”. Generally, the format is as follows:

  • Abstract. This is usually limited to between 150-300 words and can either take on a structured or unstructured format. As this is often the only section that most readers will ever see it is important to make you message clear and concise.

  • Main body 3000-5000 words

    • Introduction.

This should be limited to approximately 500 words covering a brief review of the literature and the rationale for the study. The introduction of other study documents such as Protocols or CSRs can be used as a starting point for this section.

  • Methods.

A short, precise summary covering study design, subject recruitment and selection, assessments and statistical analyses performed.

  • Results.

Clear presentation of data, potentially in tables or figures (usually counting as 500 words) where possible. Any data presented within a table or figure should not be repeated in text.

  • Discussion.

This is the only section where results should be discussed, any key findings should be summarised at the start of the section. This should also cover: strengths and weaknesses of the study, any differences from similar published studies, possible implications for policymakers or clinicians, potential for future research and any key marketing messages.

 

TCTC can support and guide you through the process of manuscript preparation and offers medical writing services as part of full service projects or as individual items through the Regulatory Affairs Company Ltd.

 

1.https://www.ncbi.nlm.nih.gov/pubmed/28039032

2.https://www.nature.com/articles/d41586-018-02404-4

3.https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2017_01_26_summaries_of_ct_results_for_laypersons.pdf

 

 

 

 

 

 

 

 

 

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