Lean Writing Does Not Mean Lazy Writing

In my observation of efforts to embrace lean writing across regulatory submission documents, I find a troubling trend has emerged: I am seeing lazy writing, not lean writing.

Pharma clients are increasingly voicing concerns that critical content—especially in key “end-game” submission documents like Module 2.5—is being trimmed so aggressively that essential context, rationale, and reader guidance are vanishing altogether. In some submissions, a placeholder sentence has replaced the entire substance of a required overview discussion. For example I have found the following in a Clinical Overview I was asked to review: "For Pop PK, refer to Section 2.7.3.x. Where the text states: No concerns regarding intrinsic or extrinsic factors. For full details, refer to 5.3.3.x."

This is not lean writing. This is abdication.

I expect the discussion of Pop PK in the Clinical Overview to provide a concise but informative synthesis that supports the understanding of dose selection, variability, and applicability across patient subgroups. I want a high-level summary on the data sources and modeling approach. I do not want to leave the document to learn these details. Remember, the busy, selective regulatory reader's needs are immediate, not later. Give me the "So what?" here and I will decide if I want to follow the link.

Cutting to the Bone (or Into It)
The intent of lean writing is to eliminate noise, not substance. Lean writing means focus on what a section is to “do” and what is the “So what?”. Lean writing is about reducing clutter—repetition, irrelevance, hedging, verbosity—not impacting clarity, logic, or the reader’s ability to understand, navigate, and assess.
The "write it once and refer" principle does not mean we get to skip the responsibility of previewing what is important, or overviewing the details that support the “So what?” and why the details matter.

Lean Writing Is a Reader-Centered Discipline
Lean writing is not about writing less—it is about writing smart. Lean writing designs information to reflect reading behavior. Lean writing anticipates the reader’s questions and designs plans to provide a clear response. The lean writing style builds scaffolding within a section so the reader can move efficiently from “So what?” overview to evidence and analysis. Lean writing provides the mental handles that allow the reader to judge the relevance, reliability, and meaning of the details found elsewhere. Lean writing reduces noise, not meaning. And meaning needs structure, context, and care. Hyperlinking without context and care for the reader is not lean. It is lazy. The busy, decision-making regulatory reviewer is not looking for breadcrumb trails. They are looking for clarity, logic, and confidence that you, the Sponsor, got the “So what?” right.
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