Writing for Regulatory Agencies vs. Medical Journals: The Differences
by Megan Day, AA, BA, PhD (ABD)
When a clinical trial is completed, regardless of the outcome, the results need to be shared. From a regulatory perspective, they have to be shared.
On the other hand, from the perspective of disseminating information throughout the scientific community, researchers may decide they want to share the information to a broader audience. The best avenue for this is publication in a scientific journal.
For a medical writer, these are two very different tasks.
Who are you writing for?
Regulatory writing is highly standardized and requires rigid adherence to the guidelines developed by the agencies governing the review and approval process. In addition to these guidelines, companies have our own standard operating procedures (SOPs) that ensure compliance at every step of the clinical trial reporting process and harmonization across various clinical trial programs.
The end result is a very thorough, detailed, and complete presentation of the entire clinical trial, from inception at the protocol level, to completion with final data.
The final report that is produced – a Clinical Study Report – can be very lengthy, many times exceeding one hundred pages or more. It is a dense, detailed, and intricate document, with a purpose to provide a full account of the conduct and outcome of the clinical trial. The regulatory agencies, by design, will have everything they need.
Communicating the important, possibly critical, findings from a clinical trial to other researchers and interested parties must expand beyond the clinical study report. A brief summary that captures the salient ‘take home’ messages of the outcomes can reach a large audience through professional journals.
In fact, journal publication is quite often part of a study sponsor’s strategy for wider visibility of their clinical trial. This is where the approach to reporting diverges.
Writing for medical journals
There are many choices with regards to journals, and each one has unique requirements. Once the most appropriate journal to reach the sponsor’s target audience has been selected, it becomes necessary to determine how best to structure the study results to the journal’s specific format.
There is no one size fits all approach to journal publication. Each journal has its own unique set of specifications for structure, length, and presentation.
Apart from the limitations for word count, number of allowed tables or figures, and other more cosmetic attributes, there is a decidedly different approach needed for the data presentation. Journal articles can be thought of more as a big picture document. Substantiating data needs to be presented, but in a truncated format. Additionally, the emphasis on how the data was acquired, how it was analyzed, and what it means, tends to be favored over discussion of the preliminaries as provided in a clinical study report.
Getting the abstract right
The abstract, which is generally required for journal articles of all types, is one of the most critical components. Sometimes, abstracts can be limited to as few as 150 words.
In that small space, the abstract must convey the design, conduct, and outcome of the clinical study concisely and accurately. For much of the journal’s reading audience, the abstract may be the only part of the article that is read, and it will be vital for making the article searchable.
Whether writing a clinical study report or a journal article, both illustrate the summarization of clinical trial data, serving multiple functions. Regardless of formatting, structure, and organizational limitations, medical writers are tasked with the ultimate goal of communicating complex data clearly and accurately. This in turn contributes to the knowledge base that ultimately furthers research – in all its forms.
About the author
Megan Day, AA, BA, PhD (ABD) is a Senior Medical Writer on the MMS European writing team, based in Dublin, Ireland.