# Individual response

**URL:** <https://discourse.datamethods.org/t/individual-response/5191>\
**Category:** data analysis\
**Tags:** rct, interpretation, design\
**Created:** [December 16, 2021, 9:57am UTC](https://discourse.datamethods.org/t/individual-response/5191 "2021-12-16T09:57:24Z")\
**Posts on this page:** 1\
**Showing post:** 271

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**Author:** ![davidcnorrismd](https://discourse.datamethods.org/user_avatar/discourse.datamethods.org/davidcnorrismd/32/3502_2.png) [@davidcnorrismd](https://discourse.datamethods.org/u/davidcnorrismd)\
**Post date:** [November 17, 2025, 8:53am UTC](https://discourse.datamethods.org/t/individual-response/5191/271 "2025-11-17T08:53:39Z")

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> "There are several aspects of Baby K.J.’s story that define the FDA’s plausible mechanism pathway.
> 
> …
> 
> Fifth, there is an improvement in clinical outcomes or course. In conditions with progressive deterioration, consistent improvements will be viewed favorably by the FDA."

Here, this plausible-mechanism piece seems to describe N-of-1 _scientific_ reasoning that proceeds without need for statistics to glean a faint signal out of masses of data.

> **[The Gleaners](https://en.wikipedia.org/wiki/The_Gleaners)**
>
> The Gleaners (Des glaneuses) is an oil painting by Jean-François Millet completed in 1857. It is held in the Musée d'Orsay, in Paris.
> It depicts three peasant women gleaning a field of stray stalks of wheat after the harvest. The painting is famous for featuring in a sympathetic way what were then the lowest ranks of rural society; it was received poorly by the French upper classes.
> Millet's The Gleaners was preceded by a vertical painting of the image in 1854 and an etching in 1855. Millet unv...

Its vagueness and superficiality notwithstanding, the piece at least does not describe approvals of marginally-effective drugs such as I addressed in “ [Where are the exceptional responders?](https://discourse.datamethods.org/t/where-are-the-exceptional-responders/17961) ”.

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