The Optimizing Medical Writing for the Regulatory Reader Workshop will now be held 29-31 October in Copenhagen. More information on this three-day workshop can be found at the Atrium website: https://www.atriumcph.com/course/Optimizing-Medical-Writing-for-the-Regulatory-Reader/56871
Watch for the full program announcement from Atrium. In interim, here’s the “thumbnail” overview of our course:
I will be co-facilitating Optimizing Medical Writing for the Regulatory Reader in Copenhagen in August. This will be a three-day public workshop that will allow attendees time to dive deep into the topic with expanded discussions and group exercises using case study documents. More details can be found on my LinkedIn page or on Atrium's registration page.
Document review in pharma and medical device enterprises is a system of diverse and complex functions that requires proficiency in technology, process discipline, and most importantly intellectual capital.
In terms of technology, there is the management and optimization of the review platform capabilities, the appropriate use of technology assisted review, and effective data security controls throughout the documentation life cycle.
As we think of process discipline, there is the need for various robust policies and procedures and a commitment at a senior level to execute those policies and procedures consistently and effectively. Additionally, there is the need to carefully consider the right time/correct role deployment of people during the various reviews.
As for intellectual capital, I mean there is effective knowledge transfer; knowledge retention; learning, training, technological, statistical, and linguistic acumen applied to every round of review. In essence, the careful curation of document review expertise.
Taking a hard look at review, there are a lot of moving parts and as time lines are reduced and the scale and complexity of document platforms rise, the need for a well-functioning environment rises exponentially and perhaps even geometrically.
From my perspective, this means, the value of organizational competence in document review as denoted by process maturity far exceeds the value of the component parts (people, process, technology). In short, the best technology (if one exists) and the “best” people may be utilized, but if the organizational vision within which they operate is deficient, the result will most likely be sub-optimal. It is process maturity that provides the framework in which the contribution of people and technology can excel or be inhibited.
When it comes to document review in pharma and medical device, I keep thinking about Peter Senge's comment: “Organizations break down, despite individual brilliance and innovative products, because they are unable to pull their diverse functions and talents into a productive whole.”
It has been some time since I last posted here on the McCulley/Cuppan blog. Just like some other things in my life, I simply got out of the habit. So, like my physical workouts, I am looking to make blog posts a more regular part of my life.
With that said, onto the question I want to consider in this post--why are most research documents that cross my computer screen written in the passive voice? Literally, many, if not all of the clinical research reports, much of the regulatory documentation, and painfully all of the clinical research protocols are written in the passive voice.
Why do I even bring this topic up? Well, some researchers in the academic community feel that the use of the passive voice (verbs that do not indicate who or what is doing the action) can lead to writing where the sources or agents of action are not clear. This is my big criticism of protocols, a class of documents centered on characterizing events and agents.
These writing researchers also comment that repeated use of the passive voice results in texts, which are “flat and tedious” to read. From my very subjective perspective, I have to agree with that last comment as I have certainly seen my share of documents that fit this description.
It is worth noting here too that reading research shows most readers prefer active voice, especially readers for whom English is not their mother tongue.
The point of this blog is not a grammar lesson (trust me I’d never do that as I almost fall asleep from boredom when someone mentions the word grammar.) But just to be sure we are all on the same page by what I mean with ‘passive voice’ versus ‘active voice’; here is my explanation in a nutshell:
Passive sentences that I read by the truck load contain phrases such as these:
The worst abuse of passive voice is the heavy use of state-of-being verbs combined with past tense: (is, was, be) + (past tense) like the following examples:
So back to the point of this discussion. I ask this question about the habitual use of the passive voice because many science journals, like Nature, and most of the leading style guides recommend the active voice over the passive voice. So if the top-flight journals like Nature and the leading style guides like the Chicago Manual of Style recommend writing in the active voice, then why do people working in pharmaceutical and medical device companies still demand passive voice as the default style pathway?
When I ask people in the workshops I teach at various pharmaceutical and medical device companies why they slavishly write in passive voice, the answers range from: “I did not know that is the style I was using.” to “This is the way science must be written.” Ignorance is never an acceptable excuse, but to invoke the need to meet some mythical style-standard is absurd. The slavish use of the passive voice in science writing is a self-maintained and mutually-committed act drawn from a fairy tale. I use the term fairy tale here with careful consideration. Fairy tales are about imaginary worlds. Hereto we have a situation where people imagine what readers want and prefer and routinely invoke the imaginary in defense of their personal or organizational belief system about high quality scientific writing.
From my perspective, the two leading reasons that the passive writing style is so broadly applied are:
I am working my way through some papers addressing the psychological mechanisms that form and maintain habits in work groups and organizations. Now I am looking for references related to the meaningful steps necessary to mitigate or eliminate these habits. When and if I find an effective elixir for this bad writing habit, I will let you know.
Gregory Cuppan is the Managing Principal of McCulley/Cuppan Inc., a group he co-founded. Mr. Cuppan has spent 30+ years working in the life sciences with 20+ years providing consulting and training services to pharmaceutical and medical device companies and other life science enterprises.