On Common Sense and Conventional Wisdom when it comes to lean writing in the biopharmaceutical industry

Whether this quote, “Common sense is nothing more than a deposit of personal prejudices …” came from Albert Einstein or his biographer Lincoln Barnett, we’ll never know for sure. But we know Einstein did say “For every new idea one encounters in later years, one must combat the accretion of “self-evident” concepts and personal prejudices”.

We know the economist John Kenneth Galbraith coined the term, “conventional wisdom”. Galbraith said, “Conventional wisdom has a property analogous to inertia … sometimes to the point of absurd denial of the new information or interpretation by persons strongly holding an outdated but conventional view.”

I routinely refer to these quotes in my regulatory writing workshops when we address the topic of lean writing. I invoke the two quotes whenever somebody argues that lean writing is an inappropriate approach for complex science. The quotes are also invoked when the argument is, “well it is common sense that this document should stand alone with every last detail wound into the documents framework.”

I ask for meaningful evidence to support these positions. At best I get silence or I might get some narrative that is a version of conventional wisdom. “I’ve been thinking about documents in this manner for the past 30 years. It worked then and it works now. Are you trying to tell me I am wrong?” Another variant is, “Well everybody knows that regulators and clinical investigators expect to receive documents designed and written in this manner.”

Really? Where’s the evidence?

I don’t want to suggest anybody is wrong. Rather I want to be pragmatic. I suggest:

• Why do you want to work so hard to generate content that nobody is going to read.
• Why is it that you assume you are writing for a passive reader who goes to page 1 and will diligently read straight through to page X.
• Why is it you assume your reader has an abundance of time to read everything you write.

We have considerable evidence to suggest lean writing is a very appropriate strategy to meet the needs of the busy, highly selective decision-making reader.

Here is a case-in-point of what is often so wrong with writing in the biopharmaceutical space. I am bemused by the collective effort thrown into generating noise that is pumped into an Investigator’s Brochure. First off, take a moment to look up the working definition of the term “brochure”. What we produce as an industry clearly defies the definition of “information on a topic in a concise and visually appealing format”. I recognize that the general definition of a brochure is too extreme for what we need to present to a clinical investigator. However, I have to suggest that what we do produce almost always defies the working definition for an Investigator’s Brochure presented in the ICH E6 guidance. I quote here directly from the guidance:

“Purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial. The information should be presented in a concise, simple, objective, balanced, and non-promotional form that enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial.”

Guidance goes on to state that “information should be provided in a summary form using tables.” No, we are not going to do that, we love words. Readers want words, not tables. That's conventional wisdom.

Here, I ask the question, where does it say that the IB is a warehouse for all of our development information? However, the counterpoint of conventional wisdom strikes a different note to my query. “Oh Greg, we have to put all these details in. Our template demands this approach. Besides, what if somebody wants to take a more in-depth review of our science? We have to account for that one reader.” Another frequent comment is, “It is what we always have done, therefore it must be right”. Really?

Oh, that conventional wisdom bell is ringing loud and long. The end result, what is commonly called a brochure, now becomes a big fat document of more than 80 pages by the 3rd edition.

Once again, I invoke, “why do you want to work so hard to write something that nobody is going to read?”

In summary, applying lean writing principles to regulatory documents is essential for promoting clarity, reducing ambiguity, enhancing compliance, streamlining the time on task, and most importantly, supporting our primary reading audience. Lean writing as a discipline benefits both the readers and those authoring the documents.

A final note for you: Einstein valued the simplicity and elegance of well-constructed scientific writing. He famously said, “Everything should be made as simple as possible, but not simpler.” This statement reflects his focus on the importance of distilling complex ideas into the most straightforward and comprehensible forms possible. Done of course without oversimplifying to the point of losing precision or coherence. He believed in taking words off the page to help the reader. Bottom line, Einstein believed in the value of lean writing.