Re: [External] Re: Multiple race coding
Scientifically no...
The FDA guidance ( https://www.fda.gov/media/75453/download) explicitly
acknowledges that the "race and ethnicity categories were not anthropologically
or scientifically-based designations, but instead were categories that
described the sociocultural construct of our society". The categories were
devised by the Office of Management and Budget for classification of the US
population.
While there might be some differences between the categories defined in the
guidance due to differences in socio-economical background, risk factors,
frequencies of certain genotypes/phenotypes, these self-declared categories are
just indirect reflections of much fundamental factors and are quite by
definition subjective and imperfect.
Just my 2 cents...
Sébastien Bihorel
Director, Quantitative Pharmacology
[email protected]
Quoted reply history
________________________________
From: [email protected] <[email protected]> on behalf of
Bart Laurijssens, BEL Pharm Consulting <[email protected]>
Sent: Tuesday, December 9, 2025 3:58 AM
To: Leonid Gibiansky <[email protected]>; Paul Hutson
<[email protected]>; Nmusers <[email protected]>
Subject: [External] Re: [NMusers] Multiple race coding
Just curious, Can anybody explain the, scientific, rationale for using "RACE"
as a covariate? Why not eye colour? Thanks in advance, Bart Bart Laurijssens
BEL Pharm Consulting 116 Chemin du Moulin d'Ozil 07140 Chambonas France +33
(0)6 85 16
Just curious,
Can anybody explain the, scientific, rationale for using "RACE" as a covariate?
Why not eye colour?
Thanks in advance,
Bart
Bart Laurijssens
BEL Pharm Consulting
116 Chemin du Moulin d'Ozil
07140 Chambonas
France
+33 (0)6 85 16 55 94
[email protected]<mailto:[email protected]>
On 08/12/2025 21:23, Leonid Gibiansky wrote:
I've seen it coded as "Multiple" category, and used similar to "Other" (i.e.,
not very helpful)
On 12/8/2025 10:39 AM, Paul Hutson wrote:
I’ve got a study in which subjects have the option of identifying as belonging
to more than one race.
How are others in this group:
1. Coding this in their data file
2. Incorporating this as a possible covariate in their PopPK model?
Thanks!
Paul
Paul R. Hutson, PharmD, BCOP
Distinguished Professor (CHS)
Thora M. Vervoren Professor for Research in Psychoactive Substances
UW School of Pharmacy
Director, UW Madison Transdisciplinary Center for Research in Psychoactive
Substances
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Regeneron - Internal
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