The intended final stage of a clinical research project is, of course, the writing up of the results and their publication in a medical journal. After all, decision and policy makers, as well as clinicians, medical writers and other researchers, rely on the publication of healthcare evidence in medical literature for their information. While having the submission to a journal completed by a professional medical writer will greatly help with getting the results published, it is well-known that journals primarily select manuscripts and papers on the basis of how they answer three questions:
- Is it true: Does it have internal and external validity; and does the evidence support the conclusions?
- Is it new: How does it advance the field?
- How will it affect patient care?
In addition, it is a fact of life that researchers, medical writers and journals are typically more interested in the publication of trials that demonstrate either a large treatment effect for a new therapy, known as positive trials, or the equivalence of two approaches to treatment, termed non-inferiority trials. Unfortunately, there is less enthusiasm for so-called negative studies, which indicate a new treatment is inferior to standard treatment, and for inconclusive trials as these studies offer neither a clearly positive nor clearly negative result and so will not change clinical practice. 
Alongside these factors, entire studies or specific results within a study may fail to reach publication due to control of the data by the sponsor, incomplete analysis, an incomplete study or rejection by journals, regardless the quality of the medical writing. 
Focusing on the latter, it is worth nothing that a study may be rejected by a journal even if it receives a positive response during the peer-review process. However, such reviews form only a part of the decision. Factors that can lead to a manuscript being rejected may include a fatal flaw, such as conclusions not being supported or poor study design or execution, the reporting of secondary outcomes in a major study, there being nothing to distinguish the findings from previous work, a small effect size/wide confidence interval or too much work required from the editorial department at the journal.
If a paper is rejected, it may be possible to ask a medical writer to revise the paper and bring it into line with the author guidelines of another journal and submit it there. Or you could ask for the paper to be reconsidered, with any appeal taking into account all of the editor’s and reviewers’ comments.
Alternatively, a manuscript may be provisionally accepted, which is, basically, an invitation to respond to the comments received on the original paper and then submit a revised version. Such comments can range from a few paragraphs to detailed comments running for pages and pages. Working with a medical writer, answering each comment specifically and in detail can lead to drastic improvements in the quality of the manuscript, and substantially improve the chances of it being accepted.
It may be that you have to re-run your analyses using a different methodology, or re-think the arguments you have used to support your findings. It is always worth remembering that the ways in which your study is interpreted may differ widely, depending on the perspective of the reader. Most of all, it should be borne in mind that concise articles that get straight to the point and use the clearest language possible always have a much better reception, regardless of the audience.
Drop us a line or give us a call to find out more about our medical writing services. Even if you have already completed a manuscript based on your clinical research, we are highly skilled at bringing a paper into line with submission guidelines and structuring and editing the text to present the information in as clear and direct a way as possible. We can also incorporate any comments received from a review process and can suggest alterations that could improve the chances of your research being published. As part of our medical writing services, we can also create a shortlist of journals that would be particularly receptive to your work.
- De Angelis C et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004; 351: 1250-1251.
- O’Halloran R. Transparency in disclosure of clinical trial information. The Write Stuff 2006; 15: 15–17.