Tips for Argumentation in Regulatory Writing

Authoring regulatory interaction documents, like briefing books or response letters, requires an artful approach. These documents are essentially arguments in support of the sponsor’s clinical development plan and need to be both accurate and persuasive. The tips below may help you the next time you are authoring a regulatory interaction document:

1.     Quality over quantity. Avoid combining multiple arguments into one. Each position should be clearly stated and supported with relevant data to merit standing on its own. Flooding your document with too many or overlapping arguments to “beef up” your position only leaves the reviewer in doubt of what your position actually is.

2.     Showing your warts. Anticipate the concerns that regulators might have with your position and try to address these upfront. Consider elucidating an opposing view. Demonstrating a broad consideration of potential limitations and complexities and countering them can only strengthen your position.

3.     Broad to specific. Build your arguments logically. Orient your reviewer with your general premise, which acts like the foundation, upon which more detailed and supporting information can be added. Jumping right into the deep end with specifics will only muddy the waters, making it difficult for reviewers to appreciate the strength of your argument.

4.     Less is more. This one is tough for most sponsors. There is a knee-jerk reaction to pack the document with more and more data. But effective argumentation requires the exact opposite – restraint. Be respectful of your reviewers’ time. Compelling data from a primary endpoint are not necessarily enhanced by adding two or three secondary endpoints that directionally support the same conclusion. If regulators want more data, believe me, they will ask for it.

Regards,

Justin McLaughlin, CEO