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] ________________________________ 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 <https://www.research.pharmacy.wisc.edu/tcrps><https://urldefense.com/v3/__https://www.research.pharmacy.wisc.edu/tcrps__;!!ODpDvJZr5w!DmX9Ey-X1SNCW76kw1Ue8BEYSXMIpL_lfgs3SVJSoWj9VMXlLIGUOZVSza2rU18z7di3zvrpGYmX2wvOg0OzkezJU9petySh10J0$> Faculty Leader, Paul P. Carbone Comprehensive Cancer Center Cancer Pharmacology Laboratory <https://cancer.wisc.edu/research/resources/ddc/ cancer-pharmacology/><https://urldefense.com/v3/__https://cancer.wisc.edu/research/resources/ddc/cancer-pharmacology/__;!!ODpDvJZr5w!DmX9Ey-X1SNCW76kw1Ue8BEYSXMIpL_lfgs3SVJSoWj9VMXlLIGUOZVSza2rU18z7di3zvrpGYmX2wvOg0OzkezJU9pet7Cr3HW9$> T: 608.263.2496 [email protected]<mailto:[email protected]> Regeneron - Internal ******************************************************************** This e-mail and any attachment hereto, is intended only for use by the addressee(s) named above and may contain legally privileged and/or confidential information. If you are not the intended recipient of this e-mail, any dissemination, distribution or copying of this email, or any attachment hereto, is strictly prohibited. If you receive this email in error please immediately notify me by return electronic mail and permanently delete this email and any attachment hereto, any copy of this e-mail and of any such attachment, and any printout thereof. Finally, please note that only authorized representatives of Regeneron Pharmaceuticals, Inc. have the power and authority to enter into business dealings with any third party. ********************************************************************
