When Elegant Writing Masks Flawed Thinking in Regulatory Documents

​In regulatory writing, fluency is often praised. To a fault, I might add. Documents that “read well” are
seen as polished, professional, and persuasive. But fluency can be deceptive. A troubling phenomenon is
increasingly visible across high-stakes submission documents that I can access: writing that is elegant,
but logically unsound.

​The Problem: Elegant Nonsense
​
These are documents—often Clinical Overviews, Briefing and AdComm Books, or 2.7 Summaries—where
the language flows, the sentences vary in rhythm and length, and the vocabulary sounds convincing. But
when you interrogate the logic underneath, something’s missing. There is no connective reasoning. The
claims float. The evidence is absent, circular, or only loosely linked.

I call this elegant nonsense—writing that sounds intelligent but lacks logical structure or evidentiary
support.

Examples of Elegant but Hollow Writing

• Circular Conclusions:
  “The results demonstrate strong efficacy, which is consistent with the robust outcomes observed.”
  (No new idea. The sentence loops.)
• Vague Synthesis Disguised as Insight:
  “Taken together, the data provide a compelling case for a favorable benefit-risk profile.”
  (Taken together how? What trade-offs? What reasoning?)
• Hedged Fluency:
  “The observed improvements, while preliminary, suggest a potentially meaningful clinical impact inselected populations.”
  (So… is there impact, or not? “Suggest” is a hedge added to another hedge “potential.” Is there any meat on the bone?)
• Precision Without Purpose:
  “Statistically significant improvements were observed across all measured endpoints (p < 0.05).”
  (And the relevance is…? Statistical significance is not a conclusion—what does this observation mean clinically?)
• Inference by Adjective:
  “In the largest study ever conducted in this patient population, these robust results demonstrate this novel therapeutic treatment offers a promising approach in a challenging disease setting.”
  (All the right words—none of the actual thinking. Largest study does not equate to being an appropriate and well controlled study. What makes the results ‘robust'? 'Novel' and 'promising' are evaluative fillers. What evidence supports this promise? What challenge is being satisfied?)
• Fluent Reporting without Interpretation
  “Over a median duration of follow-up for the primary endpoint of 4.7 and 4.5 years, respectively, a primary endpoint event occurred in 17.2% (705/4089) of patients in the icosapent ethyl group, as compared to 22.0% (901/4090) of patients in the placebo group over the median 4.9 year follow-up (HR of 0.752 [95% CI: 0.682 to 0.830; p=0.00000001]; RRR of 24.8%; absolute risk reduction [ARR] of 4.8%; and number needed to treat [NNT] of 21). Thus, the primary endpoint was met, demonstrating a substantial and statistically significant lower risk of major adverse CV events with icosapent ethyl than with placebo.”
  (The passage piles up quantitative data but never explains why these results matter or how to interpret the magnitude of benefit. “Substantial and statistically significant” is a stylistic conclusion. What does 'substantial' mean in this clinical context? Substantial compared to what? For whom? At what cost or risk?)

These examples are not rare—they are systemic. But what makes this kind of writing so persistent in
high-stakes submission documents?

Why This Happens

• Over-reliance on polished templates or legacy phrasing
• Desire to “sound smart” in high-stakes documents
• Misunderstanding fluency as a proxy for rigor
• Fear of being too direct, especially with uncertain or marginal data

But the result is the same—writing that passes the eye test but fails the decision test.

Why It is Dangerous
Regulatory readers are trained to look beyond the language. They must detect bias, weigh risk, evaluate strength of evidence, and make yes/no decisions under pressure. When documents rely on polished language to mask weak thinking, reviewers lose confidence—not just in the section, but in the entire argument. This is the affective level of information design, as suggested by Saul Carliner.

Carliner noted that when writing feels effusive (demonstrative, lavish) or evasive, then the writing erodes the reader’s trust—not only in what is stated, but in why it is stated that way. In regulatory contexts, that erosion is consequential: it casts doubt on the sponsor’s judgment and forces the reviewer to work harder to separate signal from gloss.

Elegant writing that lacks rigor is not just ineffective—it can be misleading.

How to Spot and Fix It
Interrogate every conclusion
– What is this based on? Where’s the data? Is the reasoning clear?

Replace vague synthesis with structured logic
– Instead of “Taken together,” show how the pieces fit.

Simplify to clarify
– If the sentence reads like corporate poetry, ask: is it hiding uncertainty?

Separate fluency from function
– Does this paragraph sound good, or does it do its job?

Consider the phrase: “This study is adequate and well-controlled.”
The phrase appears routinely in regulatory documents—concise, confident, and aligned with regulatory
guidance language. But unless the concepts are substantiated, this sentence is nothing more than
elegant shorthand.

Why It Sounds Smart
It mimics the regulatory lexicon (such as 21 CFR 314.126).
It conveys confidence in the study's design.

It’s often used to bridge to conclusions about efficacy or labeling claims.

Why It May Be Elegant Nonsense
If the surrounding text contains no analysis of the “whys” for:

• control group selection
  
• blinding or randomization method
  
• endpoint appropriateness
  
• sample size justification
  
• protocol amendments
  
• protocol deviations
  
• participant heterogeneity

Then the phrase is merely a performative placeholder—an assertion dressed up as evidence. The writing
must move from elegance to substance.

Another Example: “The Safety Profile Was Manageable”
This phrase shows up in nearly every Clinical Overview and Summary of Clinical Safety I read. The phrase
suggests confidence, but what does it actually mean?

Why It Sounds Smart
It’s concise and optimistic.
It implies clinical actionability—something prescribers and regulators care about.

Why It May Be Elegant Nonsense
“Manageable” sidesteps reasoning. The term offers a verdict without evidence. I suggest that without explaining what was managed and how, this phrase is:

• Subjective (manageable for whom? under what conditions?)
• Empty (not tied to severity, reversibility, or impact)
• Misleading (may mask dose holidays or reductions)

The phrase has become a narrative crutch, offering the appearance of interpretation while avoiding the
informative work. “Manageable” carries a positive emotional valence (“feel good factor”) without
conveying analytical substance. It is language designed to reassure, not inform.

Bottom Line
Polished phrases like “adequate and well-controlled” or “manageable safety profile” only serve the
reader when tethered to evidence and logic. Elegant language that obscures complexity—or avoids
specifics—undermines trust in the message. In regulatory writing, clarity must be earned. You make a
claim, you better prove it.

A Better Standard
The goal of regulatory writing is not to sound polished. The goal is to communicate rationales for
interpretations and decisions—clearly, truthfully, and logically.

Regulatory decisions shape public health. Regulatory reviewers must decide under pressure, with
limited time. Our job as writers is not just to report and write elegant prose—but to demonstrate
thinking on the page.

Writing that hides uncertainty or skips reasoning does not just fail the reader. It fails the process.

• Let elegance serve clarity.
• Let language serve logic.
• Let writing serve decisions.

Also published to LinkedIn July 2, 2025. https://www.linkedin.com/pulse/when-elegant-writing-masks-flawed-thinking-regulatory-gregory-
cuppan-qmmrc