Importance of Language and Writing Style in a Clinical Study Report

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How important is language and writing style in a clinical study report?  I was recently asked this question by a medical writer working for one of my McCulley/Cuppan clients. The writer is dealing with a team that seems to obsess over every word in every draft and the writer is looking for some help in how to address the situation.


Here is my response to the question:


You are asking about lexical and syntactical elements of writing (the third element of writing is grammatical.) 


Lexical pertains to the words (vocabulary) of a language. In the context of clinical research we need to talk about several applied lexicons of scientific phraseology that apply broadly to science and then narrowly to a specific therapeutic area. The admittedly most distinctive feature of any clinical study report is the application of specific scientific and technical prose. So, language is very important in a CSR to avoid lexical ambiguity (why I so love statisticians and their demands for careful use of language when describing statistical observations) in order to allow the reader to derive the intended meaning.


My experience suggests that many people in Pharma think attention to syntactical elements (style) means they are either eliminating ambiguity or improving clarity of message. Rarely is this the case.


You have heard me say before that style does not matter in the type of writing represented in clinical study reports submitted to regulatory authorities in the US and elsewhere.

My position is supported by current discourse theory. Discourse theory states that, as a rule in scientific writing, meaning is largely derived from the precise use of key scientific words, not how these words are strung together. It is the key words that create the meta-level knowledge of the report. Varying style does little to aid or impede comprehension.


What happens is people often chase and play around with the style of document. Largely they are looking to manipulate an advanced set of discourse markers specific for clinical science writing or some subset specific to a therapeutic discipline. Discourse markers are the word elements that string together the key scientific words and help signal transitions within and across sentences. These discourse markers are the elements that provide for style. There are macro markers (those indicating overall organization) and micro markers (functioning as fillers, indicating links between sentences, etc.) Comprehension studies show that manipulating discourse markers--that is, messing with style--in most instances does not influence reader comprehension. It is worth noting that manipulation of macro markers appears to have some impact on comprehension for non-native speakers of English (why it is worth using textual advanced organizers to help with document readability.)


So the net-net is: there is little fruit to be picked from messing with style in a clinical study report. Put review focus on the use and placement of key terms.


This is a bit of a non-sequitur to the question, but a concept I’d like to share. To derive meaning from scientific text, readers will rely on their prior knowledge, and cues provided by the key terms and data they encounter or fail to find in a sentence, paragraph, table, or section of a clinical study report. So what I’d really prefer to get people thinking about is the semantical elements of their documents. Semantics is fundamentally about encoding knowledge and how you as an author enable the reader to process your representation of knowledge in a meaningful way. Semantics is about how much interpretive space you provide to the reader in a document by what you say and equally important, by what you do not say. Of course you cannot get to the point of thinking about semantics unless you see clinical study reports as something more than just a warehouse for data.