Thanks Sébastien,
I have seen the guidance. I do not find the guidance compelling. Can we
do something meaningful with the information if we find a RACE covariate
effect?
I am not even sure how well the RACE categories describe a sociocultural
construct. It seems all quite arbitrary to me.
Do we evaluate RACE only because it is in the guidance?
/Bart Laurijssens/
*BEL* Pharm Consulting
/116 Chemin du Moulin d'Ozil
07140 Chambonas
France
+33 (0)6 85 16 55 94
[email protected]/
On 09/12/2025 14:48, Sébastien Bihorel wrote:
Scientifically no...
The FDA guidance (https://www.fda.gov/media/75453/download
<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]
------------------------------------------------------------------------
*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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