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
https://www.research.pharmacy.wisc.edu/tcrps
Faculty Leader, Paul P. Carbone Comprehensive Cancer Center Cancer Pharmacology
https://cancer.wisc.edu/research/resources/ddc/cancer-pharmacology/
T: 608.263.2496
[email protected]
Multiple race coding
I've seen it coded as "Multiple" category, and used similar to "Other" (i.e., not very helpful)
Quoted reply history
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 >
>
> Faculty Leader, Paul P. Carbone Comprehensive Cancer Center Cancer Pharmacology Laboratory < https://cancer.wisc.edu/research/resources/ddc/ cancer-pharmacology/>
>
> T: 608.263.2496
>
> [email protected]
You could try coding it like the “gene-dose” relationship some have done for
genotypes?
Regards,
David
David Foster, PhD
Associate Professor
Research Integrity Advisor, Clinical and Health Sciences
Chair CSIRO Health and Medical Human Research Ethics Committee
Immediate Past President Population Approach Group of Australia and New Zealand
http://www.paganz.org/)
Associate Professor | HB6-14 | City West Campus CWE-20
Clinical and Health Sciences | Australian Centre for Precision Health | Group
Leader - Pharmacometrics | Australian Centre for Pharmacometrics
University of South Australia | GPO Box 2471 | Adelaide, SA, 5001
P: +61 8 8302 2055 | F: +61 8 8302 2389 | E:
mailto:[email protected]
http://people.unisa.edu.au/david.foster
Note: This message (including any attachments) is confidential and is intended
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Quoted reply history
From: [email protected] <[email protected]> On Behalf Of
Leonid Gibiansky
Sent: Tuesday, 9 December 2025 6:54 AM
To: Paul Hutson <[email protected]>; Nmusers <[email protected]>
Subject: Re: [NMusers] Multiple race coding
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://www.research.pharmacy.wisc.edu/tcrps
>
> Faculty Leader, Paul P. Carbone Comprehensive Cancer Center Cancer
> Pharmacology Laboratory
> https://cancer.wisc.edu/research/resources/ddc/ https://cancer.wisc.edu/research/resources/ddc
cancer-pharmacology/>
>
> T: 608.263.2496
>
> [email protected]<mailto:[email protected]>
>
Dear Paul Hutson,
I believe a review of how Warfarin dosing algorithms dealt with multiracial
subgroups can help you (Asiimwe IG, Zhang EJ, Osanlou R, Jorgensen AL,
Pirmohamed M. Warfarin dosing algorithms: A systematic review. Br J Clin
Pharmacol. 2021; 87: 1717–1729. https://doi.org/10.1111/bcp.14608).
Please check the supplementary materials for a compilation of dosing algorithms.
The IWPC 2009 dosing algorithm was:
√dose (mg/wk) = 5.6044 – 0.2614 (age) + 0.0087 (height) + 0.0128 (weight) –
0.8677 (VKORC1 AG) – 1.6974 (VKORC1 AA) – 0.4854 (VKORC1 unknown) – 0.5211
(CYP2C9*1*2) – 0.9357 (CYP2C9 *1*3) – 1.0616 (CYP2C9*2*2) – 1.9206 (CYP2C9*2*3)
– 2.3312 (CYP2C9*3*3) – 0.2188 (CYP2C9 unknown) – 0.1092 (Asian) – 0.2760
(Black) – 0.1032 (Mixed/Missing race) + 1.1816 (enzyme inducer) – 0.5503 (amio)
The algorithm by Bosch 2014 was:
Ln dose (mg/d) = 2.20 – 0.0106 (age) + 0.122 (BSA) – 0.190 (CYP2C9 variant
alleles) – 0.229 (VKORC1 AA) – 0.636 (VKORC1 GA) – 0.0742 (Taino) – 0.118
(African) – 0.120 (Mixed) + 0.216 (target INR) – 0.0448 (statin) – 0.233 (amio)
–0.126 (smoker) + 0.135 (DM) + 0.09837 (vit K)
You can see some algorithms used "Mixed/Missing Race" or "Mixed".
However, since this is just merging highly heterogenous subgroups into one
group, I don't think it is ideal way to do covariate modeling.
Perhaps it would be better to divide each specific multiracial group (ex.
Black/White/Asian/Multiracial1(Black&White)/Multiracial2(Black&Asian)/Multiracial3(White&Asian)/Multiracial4(Black&White&Asian)
Then, when the covariate effects for these groups cannot be estimated precisely
(ex. RSE >= 50%) or there is no advantage in including the covariate effects
for specific groups (ex. by Likelihood Ratio Test), the covariate effects for
these groups can be fixed to 0, so that the parameters are the same as the
reference race.
Sincerely,
Jun Seok Cha
Quoted reply history
________________________________
보낸 사람: [email protected] <[email protected]> 님이 Leonid
Gibiansky <[email protected]> 님을 대시하여 보냄
보냄: 화요일, 12월 9, 2025 5:32:06 오전
받는 사람: Paul Hutson <[email protected]>; Nmusers <[email protected]>
제목: Re: [NMusers] Multiple race coding
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
>
> Faculty Leader, Paul P. Carbone Comprehensive Cancer Center Cancer
> Pharmacology Laboratory https://cancer.wisc.edu/research/resources/ddc/
cancer-pharmacology/>
>
> T: 608.263.2496
>
> [email protected]
>
상기 메일은 지정된 수신인 만을 위한 것이며 부정경쟁 방지 및 영업비밀보호에 관한 법률을 포함하여 관련 법령에 따라 보호의 대상이 되는
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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]/
Quoted reply history
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 >
> >
> > Faculty Leader, Paul P. Carbone Comprehensive Cancer Center Cancer Pharmacology Laboratory < https://cancer.wisc.edu/research/resources/ddc/ cancer-pharmacology/>
> >
> > T: 608.263.2496
> >
> > [email protected]
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
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
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Regeneron Pharmaceuticals, Inc. have the power and authority to enter into
business dealings with any third party.
********************************************************************
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]/
Quoted reply history
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
> 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.
>
> ********************************************************************
There is a drug for severe heart failure (BiDil) approved only for African-Americans. I think there was a trial that failed (was worse than control), but there was a subgroup of Blacks where it seemed to work well. The company then did a separate trial in African-Americans and showed it worked.
Also, generally cardiovascular drugs work worse in Blacks than in White, so they may require different doses. Even if companies and regulators put out the same dose, hospital pharmacists and some doctors may use the info (if it's published or is in the package insert) for alternative dosing.
Quoted reply history
On the other hand proportion of poor metabolizers for P450 2D6-dependent drugs, is very different in African and Asian populations from Whites. Since genotyping/phenotyping is rarely done in standard drug development, using race is better than not looking at all.
Ekaterina Gibiansky
On 12/10/2025 4:00 AM, Bart Laurijssens, BEL Pharm Consulting wrote:
> 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
> > 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.
> >
> > ********************************************************************