Excluding patients of ethnic minority groups from clinical

trials is unethical, introduces substantial bias, and

means that findings are based on unrepresentative

populations. The National Institutes of Health Revitalization

Act 1993 requires that all minority groups be represented

in the sample in research projects supported

by the National Institutes of Health, unless there is a

clear and compelling justification not to do so. In the

United Kingdom no such legislation exists

Atkin, K.

Brown, B.

Hussain-Gambles, M.

Leese, B.

Mason, S.

English

PubMed

Johnson, Mark R.D.

Szczepura, Ala

Coventry University Pure Portal

Representation of South Asian people in randomised trials:population's ethnic profile should be recorded in all medical data.

S. Mason

Crossref

Representation of South Asian people in randomised clinical trials: analysis of trials' data

Mason, Su

Hussain-Gambles, Mahvash

Leese, Brenda

Atkin, Karl

Brown, Julia

DigitalGeorgetown

Representation of South Asian People in Randomised Clinical Trials: Analysis of Trials' Data

White Rose Research Online

This is a repository copy of Representation of South Asian people in randomised clinical trials: analysis of trials' data.White Rose Research Online URL for this paper:http://eprints.whiterose.ac.uk/167/Article:Mason, S., Hussain-Gambles, M., Leese, B. et al. (2 more authors) (2003) Representation of South Asian people in randomised clinical trials: analysis of trials' data. BMJ, 326 (7401). pp. 1244-1245. ISSN 0959-8138 https://doi.org/10.1136/bmj.326.7401.1244eprints@whiterose.ac.ukhttps://eprints.whiterose.ac.uk/Reuse See Attached Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request. doi:10.1136/bmj.326.7401.1244  2003;326;1244-1245 BMJ  Brown Su Mason, Mahvash Hussain-Gambles, Brenda Leese, Karl Atkin and Julia   datarandomised clinical trials: analysis of trials' Representation of South Asian people in http://bmj.com/cgi/content/full/326/7401/1244Updated information and services can be found at:  These include: References http://bmj.com/cgi/content/full/326/7401/1244#otherarticles7 online articles that cite this article can be accessed at:   Rapid responses http://bmj.com/cgi/eletter-submit/326/7401/1244You can respond to this article at:    http://bmj.com/cgi/content/full/326/7401/1244#responsesfree at: 8 rapid responses have been posted to this article, which you can access for serviceEmail alertingbox at the top right corner of the article Receive free email alerts when new articles cite this article - sign up in theTopic collections (640 articles) Socioeconomic Determinants of Health • (264 articles) Other Journalology •  Articles on similar topics can be found in the following collections  Notes    http://bmj.bmjjournals.com/cgi/reprintformTo order reprints of this article go to:  http://www.bmjjournals.com/subscriptions go to: BMJTo subscribe to  on 25 October 2004 bmj.comDownloaded from ment in 23/26—88% (71% to 96%)—of cases. The dis-charge destinations recommended by the geriatricianwere to a rehabilitation ward (eight patients), homewith extra support (seven), nursing home (three), NHScontinuing care (two), medicine for the elderly ward(one), hospice (one), and medical ward (one).CommentThe study confirmed the reliability and validity of theinstrument for the objective evaluation of the appropri-ateness of surgical bed occupancy in a colorectal unit. ACanadian report on the American appropriatenessevaluation protocol showed a poor validity against apanel of experts (=0.25).2 A European version of theprotocol has been suggested but has not been validatedin a substantial study.3 The validity of our instrumentneeds to be retested in other settings with a larger studypopulation. Whether the instrument can be used as atool for clinical decision making or audit needs to beconfirmed in future studies.We thank R J C Steele and M Lavelle-Jones for assisting us withconducting this study.Contributors: GBH had the original idea. AA, DZ, SLB, andKLC conducted the study. AA and GBH wrote the first draft ofthe paper, which was edited by all the other authors. All authorswere involved in the design of the study. AC is the guarantor forthe study.Funding: None.Competing interests: None declared.Ethical approval: The local ethics committee approved the study.1 Department of Health. Shaping the future NHS: long term planning for hos-pitals and related services.Consultation document on the findings of the nationalbeds inquiry. London: Department of Health, 2000. www.doh.gov.uk/nationalbeds1.htm (accessed 15 Feb 2003).2 Kalant N, Berlingurt M. How valid are utilization review tools in assessingappropriate use of acute care beds. Can Med Assoc J 2000;162:1809-13.3 Lorenzo S, Lang T, Pastor R, Tampieri A, Santos-Eggimann B, Smith H,et al. Reliability study of European appropriateness evaluation protocol.Int J Qual Health Care 1999;11:419-24.(Accepted 17 March 2003)Representation of South Asian people in randomisedclinical trials: analysis of trials’ dataSu Mason, Mahvash Hussain-Gambles, Brenda Leese, Karl Atkin, Julia BrownExcluding patients of ethnic minority groups from clini-cal trials is unethical,1 introduces substantial bias, andmeans that findings are based on unrepresentativepopulations.2 The National Institutes of Health Revitali-zation Act 1993 requires that all minority groups be rep-resented in the sample in research projects supportedby the National Institutes of Health, unless there is aclear and compelling justification not to do so. In theUnited Kingdom no such legislation exists.Participants, methods, and resultsTo determine the proportion of South Asianparticipants (the biggest minority ethnic group in Brit-ain) included in clinical trials we investigated theethnicity profile of six clinical trials recently conductedby the Northern and Yorkshire Clinical Trials andResearch Unit, University of Leeds. All were phase III,multicentre, randomised, controlled trials and hadrecruited large numbers of participants and centres.Two were national breast cancer trials for whichregional recruitment figures were available; two werenational gynaecological trials (of different surgicaltechniques for hysterectomy and for ovarian cancer);one was a national, minimally invasive trial of surgeryin colorectal cancer; and the sixth was a regional studyinvestigating the eradication of Helicobacter pylori ingeneral practice. None contained exclusion criteriathat were directly related to ethnic origin, but allpatients’ information sheets and consent forms were inthe English language only.We identified ethnic origin in the baseline data ofthree trials and identified South Asian patients by anSQL programming query. For the three remainingtrials, we analysed the names of the participants byusing a computer program (Nam Pehchan) developedby Bradford Health Authority. Researchers experi-enced in analysing South Asian names manuallychecked for discrepancies. The Nam Pehchan pro-gramme was not infallible. It did not differentiatebetween different Muslim surnames (for example,South Asian, Far Eastern, or Arabic). Therefore,forenames (which are often more specific to languageor region than surnames) were needed to identifysome South Asian participants.South Asian (Indian, Pakistani, and Bangladeshi)people comprised up to 1.7% (mean 0.6%) of total par-ticipants in the six trials (table). A community trial inLeeds and Bradford recruited the highest number ofSouth Asian participants, but this number was lowerthan expected compared with estimates of populationfigures from the Office for National Statistics.3CommentPeople of South Asian ethnic origin seem to be under-represented in clinical trials. Though not previouslysupported by data, this has been of concern toresearchers. This under-representation might be dueto investigator bias, inappropriate strategies forrecruitment, or cost issues—for example, for translatorsor translations of information sheets.4Such inequality in the ethnic origin of participants intrials has ethical and scientific ramifications becausegenetic predisposition, dietary intake, and exposure toenvironmental and occupational hazards lead to ethnicdifferences in susceptibility to diseases. Furthermore,patients’ response to drugs, how they metabolise drugs,and their concurrent diseases, as well as the side effectsof drugs, can vary between different ethnic groups.5Our small survey used only the rather crudecomparative data available for the expected SouthPapersNorthern andYorkshire ClinicalTrials and ResearchUnit, University ofLeeds, LeedsLS2 9LNSu Masonprincipal researchfellowJulia Brownhead of unitCentre for Researchin Primary Care,University of LeedsMahvashHussain-Gamblesresearch fellowBrenda Leesereader in primarycare researchKarl Atkinsenior lecturerCorrespondence to:S Masonmedsam@leeds.ac.ukBMJ 2003;326:1244–51244 BMJ VOLUME 326 7 JUNE 2003 bmj.com on 25 October 2004 bmj.comDownloaded from Asian population. We would have liked to comparemore precisely the trials’ inclusion criteria of age rangeand sex with those of the expected South Asian popu-lation, but this information is not currently available.Trials that recruited older patients would not beexpected to comprise a percentage of South Asianpeople equal to the overall figures of the Office forNational Statistics because the number of elderlySouth Asian people in the UK population is small.Increased awareness and monitoring of recruit-ment and retention of ethnic minority groups in clini-cal trials are needed, and analysis of data by ethnicity ofsubjects should be done consistently. More rigorousreview by the research ethics committee of clinical trialprotocols, payment for translation of information sup-plied to participants, community participation, andeducation of ethnic minority groups may contribute toattaining proportional representation of ethnicminorities in trials.Contributors: SM had the idea to write the report, collated thedata, helped to draft the report, and critically revised it. MH-G,JB, BL, and KA helped to formulate and revise the report.MH-G also helped to draft the report. All authors have seen andapproved the final version. SM is the guarantor.Funding: NHS Health Technology Assessment Programme. Theviews in the paper are those of the authors and not necessarilythose of the Department of Health.Competing interests: None declared.1 Ashcroft R, Chadwick DW, Clark SRL, Edwards RHT, Frith L, Hutton JL.Implications of socio-cultural contexts for the ethics of clinical trials.Health Technol Assess 1997;1:1-65.2 Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C.Threats to applicability of randomised trials: exclusion and selective par-ticipation. J Health Serv Res Policy 1999;4:112-21.3 Scott A, Pearce D, Goldblatt P. The sizes and characteristics of the minor-ity ethnic populations of Great Britain—latest estimates. Popul Trends2001;105:6-10.4 Kressin NR, Meterko M, Wilson NJ. Racial disparities in participation inbiomedical research. J Natl Med Assoc 2000;92:62-9.5 Matthews HW. Racial, ethnic and gender differences in response to medi-cines [review]. Drug Metabol Drug Interact 1995;12:77-91.(Accepted 5 February 2003)Average energy intake among pregnant women carrying aboy compared with a girlRulla M Tamimi, Pagona Lagiou, Lorelei A Mucci, Chung-Cheng Hsieh, Hans-Olov Adami,Dimitrios TrichopoulosThe birth weight of boys is about 100 g heavier thanthe birth weight of girls, and this seems to beconsistent across populations. No study, has examinedwhether the difference is because the pregnantwoman has a higher energy intake or more efficientenergy utilisation if she is carrying a male embryothan if she is carrying a female embryo. We reportdata to support the first hypothesis—that the pregnantwoman carrying a boy has a higher energy intake.Participants, methods, and resultsWe analysed data from an international prospectivestudy on dietary and non-dietary predictors ofpregnancy hormones and outcomes among womenin Boston, United States, and Shanghai, China.1Because the database of nutrients for the Chinese dietis incomplete, we present data on dietary intakes forthe US women only.Between March 1994 and October 1995, weidentified 402 eligible pregnant women during theirfirst routine prenatal visit at the Beth Israel Hospital inBoston and invited them to participate in the study. Wefollowed throughout their pregnancies the 304 womenwho consented and did not have an early pregnancytermination or twin birth. The study population, studydesign, and methods have been described.1Proportion of South Asian participants in six multicentre clinical trialsTrial typeTrial populationRecruitment figuresNo (%) South AsianparticipantsSex Age (years) RecruitmentHysterectomy Female >18 (mean 41.2 (SD 8)) National 1380 randomised 8 (0.6%)Cancer:Colorectal Male and female >18 (mean 69; range 25-94) National 584 on whom ethnicitydata are available1 (0.2%)Breast Female(post-menopausal)Mean 64 Regional 780 randomised 2 (0.3%)Breast Female(post-menopausal)Most >55 Regional 133 randomised 0 (0%)Ovarian Female >18* Regional 480 registered(242 randomised)3 (0.6%)National 559 registered(300 randomised)4 (0.7%)Helicobacter pylorieradicationMale and female 40-49 Regional 8407 participants 145 (1.7%)Office for National Statistics’ latest estimates of proportion of population that is of South Asian origin are 3.8% for the Yorkshire-Humber region and 3.4% for GreatBritain as a whole.3*Range and mean unknown.PapersPregnantwomencarrying boyshave a 10%higher energyintake thanthose carryinggirlscontinued overBMJ 2003;326:1245–61245BMJ VOLUME 326 7 JUNE 2003 bmj.com on 25 October 2004 bmj.comDownloaded from 

This is a repository copy of Representation of South Asian people in randomised clinical 
trials: analysis of trials' data.
White Rose Research Online URL for this paper:
http://eprints.whiterose.ac.uk/167/
Article:
Mason, S., Hussain-Gambles, M., Leese, B. et al. (2 more authors) (2003) Representation 
of South Asian people in randomised clinical trials: analysis of trials' data. BMJ, 326 
(7401). pp. 1244-1245. ISSN 0959-8138 
https://doi.org/10.1136/bmj.326.7401.1244
eprints@whiterose.ac.uk
https://eprints.whiterose.ac.uk/
Reuse 
See Attached 
Takedown 
If you consider content in White Rose Research Online to be in breach of UK law, please notify us by 
emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request. 
doi:10.1136/bmj.326.7401.1244 
 2003;326;1244-1245 BMJ
  
Brown 
Su Mason, Mahvash Hussain-Gambles, Brenda Leese, Karl Atkin and Julia
  
 data
randomised clinical trials: analysis of trials' 
Representation of South Asian people in
 http://bmj.com/cgi/content/full/326/7401/1244
Updated information and services can be found at: 
 These include:
 References
 http://bmj.com/cgi/content/full/326/7401/1244#otherarticles
7 online articles that cite this article can be accessed at: 
  
Rapid responses
 http://bmj.com/cgi/eletter-submit/326/7401/1244
You can respond to this article at: 
  
 http://bmj.com/cgi/content/full/326/7401/1244#responses
free at: 
8 rapid responses have been posted to this article, which you can access for
 service
Email alerting
box at the top right corner of the article 
Receive free email alerts when new articles cite this article - sign up in the
Topic collections
 (640 articles) Socioeconomic Determinants of Health •
 (264 articles) Other Journalology •
  
Articles on similar topics can be found in the following collections 
 Notes   
 http://bmj.bmjjournals.com/cgi/reprintform
To order reprints of this article go to: 
 http://www.bmjjournals.com/subscriptions
 go to: BMJTo subscribe to 
 on 25 October 2004 bmj.comDownloaded from 
ment in 23/26—88% (71% to 96%)—of cases. The dis-
charge destinations recommended by the geriatrician
were to a rehabilitation ward (eight patients), home
with extra support (seven), nursing home (three), NHS
continuing care (two), medicine for the elderly ward
(one), hospice (one), and medical ward (one).
Comment
The study confirmed the reliability and validity of the
instrument for the objective evaluation of the appropri-
ateness of surgical bed occupancy in a colorectal unit. A
Canadian report on the American appropriateness
evaluation protocol showed a poor validity against a
panel of experts (=0.25).2 A European version of the
protocol has been suggested but has not been validated
in a substantial study.3 The validity of our instrument
needs to be retested in other settings with a larger study
population. Whether the instrument can be used as a
tool for clinical decision making or audit needs to be
confirmed in future studies.
We thank R J C Steele and M Lavelle-Jones for assisting us with
conducting this study.
Contributors: GBH had the original idea. AA, DZ, SLB, and
KLC conducted the study. AA and GBH wrote the first draft of
the paper, which was edited by all the other authors. All authors
were involved in the design of the study. AC is the guarantor for
the study.
Funding: None.
Competing interests: None declared.
Ethical approval: The local ethics committee approved the study.
1 Department of Health. Shaping the future NHS: long term planning for hos-
pitals and related services.Consultation document on the findings of the national
beds inquiry. London: Department of Health, 2000. www.doh.gov.uk/
nationalbeds1.htm (accessed 15 Feb 2003).
2 Kalant N, Berlingurt M. How valid are utilization review tools in assessing
appropriate use of acute care beds. Can Med Assoc J 2000;162:1809-13.
3 Lorenzo S, Lang T, Pastor R, Tampieri A, Santos-Eggimann B, Smith H,
et al. Reliability study of European appropriateness evaluation protocol.
Int J Qual Health Care 1999;11:419-24.
(Accepted 17 March 2003)
Representation of South Asian people in randomised
clinical trials: analysis of trials’ data
Su Mason, Mahvash Hussain-Gambles, Brenda Leese, Karl Atkin, Julia Brown
Excluding patients of ethnic minority groups from clini-
cal trials is unethical,1 introduces substantial bias, and
means that findings are based on unrepresentative
populations.2 The National Institutes of Health Revitali-
zation Act 1993 requires that all minority groups be rep-
resented in the sample in research projects supported
by the National Institutes of Health, unless there is a
clear and compelling justification not to do so. In the
United Kingdom no such legislation exists.
Participants, methods, and results
To determine the proportion of South Asian
participants (the biggest minority ethnic group in Brit-
ain) included in clinical trials we investigated the
ethnicity profile of six clinical trials recently conducted
by the Northern and Yorkshire Clinical Trials and
Research Unit, University of Leeds. All were phase III,
multicentre, randomised, controlled trials and had
recruited large numbers of participants and centres.
Two were national breast cancer trials for which
regional recruitment figures were available; two were
national gynaecological trials (of different surgical
techniques for hysterectomy and for ovarian cancer);
one was a national, minimally invasive trial of surgery
in colorectal cancer; and the sixth was a regional study
investigating the eradication of Helicobacter pylori in
general practice. None contained exclusion criteria
that were directly related to ethnic origin, but all
patients’ information sheets and consent forms were in
the English language only.
We identified ethnic origin in the baseline data of
three trials and identified South Asian patients by an
SQL programming query. For the three remaining
trials, we analysed the names of the participants by
using a computer program (Nam Pehchan) developed
by Bradford Health Authority. Researchers experi-
enced in analysing South Asian names manually
checked for discrepancies. The Nam Pehchan pro-
gramme was not infallible. It did not differentiate
between different Muslim surnames (for example,
South Asian, Far Eastern, or Arabic). Therefore,
forenames (which are often more specific to language
or region than surnames) were needed to identify
some South Asian participants.
South Asian (Indian, Pakistani, and Bangladeshi)
people comprised up to 1.7% (mean 0.6%) of total par-
ticipants in the six trials (table). A community trial in
Leeds and Bradford recruited the highest number of
South Asian participants, but this number was lower
than expected compared with estimates of population
figures from the Office for National Statistics.3
Comment
People of South Asian ethnic origin seem to be under-
represented in clinical trials. Though not previously
supported by data, this has been of concern to
researchers. This under-representation might be due
to investigator bias, inappropriate strategies for
recruitment, or cost issues—for example, for translators
or translations of information sheets.4
Such inequality in the ethnic origin of participants in
trials has ethical and scientific ramifications because
genetic predisposition, dietary intake, and exposure to
environmental and occupational hazards lead to ethnic
differences in susceptibility to diseases. Furthermore,
patients’ response to drugs, how they metabolise drugs,
and their concurrent diseases, as well as the side effects
of drugs, can vary between different ethnic groups.5
Our small survey used only the rather crude
comparative data available for the expected South
Papers
Northern and
Yorkshire Clinical
Trials and Research
Unit, University of
Leeds, Leeds
LS2 9LN
Su Mason
principal research
fellow
Julia Brown
head of unit
Centre for Research
in Primary Care,
University of Leeds
Mahvash
Hussain-Gambles
research fellow
Brenda Leese
reader in primary
care research
Karl Atkin
senior lecturer
Correspondence to:
S Mason
medsam@leeds.ac.uk
BMJ 2003;326:1244–5
1244 BMJ VOLUME 326 7 JUNE 2003 bmj.com
 on 25 October 2004 bmj.comDownloaded from 
Asian population. We would have liked to compare
more precisely the trials’ inclusion criteria of age range
and sex with those of the expected South Asian popu-
lation, but this information is not currently available.
Trials that recruited older patients would not be
expected to comprise a percentage of South Asian
people equal to the overall figures of the Office for
National Statistics because the number of elderly
South Asian people in the UK population is small.
Increased awareness and monitoring of recruit-
ment and retention of ethnic minority groups in clini-
cal trials are needed, and analysis of data by ethnicity of
subjects should be done consistently. More rigorous
review by the research ethics committee of clinical trial
protocols, payment for translation of information sup-
plied to participants, community participation, and
education of ethnic minority groups may contribute to
attaining proportional representation of ethnic
minorities in trials.
Contributors: SM had the idea to write the report, collated the
data, helped to draft the report, and critically revised it. MH-G,
JB, BL, and KA helped to formulate and revise the report.
MH-G also helped to draft the report. All authors have seen and
approved the final version. SM is the guarantor.
Funding: NHS Health Technology Assessment Programme. The
views in the paper are those of the authors and not necessarily
those of the Department of Health.
Competing interests: None declared.
1 Ashcroft R, Chadwick DW, Clark SRL, Edwards RHT, Frith L, Hutton JL.
Implications of socio-cultural contexts for the ethics of clinical trials.
Health Technol Assess 1997;1:1-65.
2 Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C.
Threats to applicability of randomised trials: exclusion and selective par-
ticipation. J Health Serv Res Policy 1999;4:112-21.
3 Scott A, Pearce D, Goldblatt P. The sizes and characteristics of the minor-
ity ethnic populations of Great Britain—latest estimates. Popul Trends
2001;105:6-10.
4 Kressin NR, Meterko M, Wilson NJ. Racial disparities in participation in
biomedical research. J Natl Med Assoc 2000;92:62-9.
5 Matthews HW. Racial, ethnic and gender differences in response to medi-
cines [review]. Drug Metabol Drug Interact 1995;12:77-91.
(Accepted 5 February 2003)
Average energy intake among pregnant women carrying a
boy compared with a girl
Rulla M Tamimi, Pagona Lagiou, Lorelei A Mucci, Chung-Cheng Hsieh, Hans-Olov Adami,
Dimitrios Trichopoulos
The birth weight of boys is about 100 g heavier than
the birth weight of girls, and this seems to be
consistent across populations. No study, has examined
whether the difference is because the pregnant
woman has a higher energy intake or more efficient
energy utilisation if she is carrying a male embryo
than if she is carrying a female embryo. We report
data to support the first hypothesis—that the pregnant
woman carrying a boy has a higher energy intake.
Participants, methods, and results
We analysed data from an international prospective
study on dietary and non-dietary predictors of
pregnancy hormones and outcomes among women
in Boston, United States, and Shanghai, China.1
Because the database of nutrients for the Chinese diet
is incomplete, we present data on dietary intakes for
the US women only.
Between March 1994 and October 1995, we
identified 402 eligible pregnant women during their
first routine prenatal visit at the Beth Israel Hospital in
Boston and invited them to participate in the study. We
followed throughout their pregnancies the 304 women
who consented and did not have an early pregnancy
termination or twin birth. The study population, study
design, and methods have been described.1
Proportion of South Asian participants in six multicentre clinical trials
Trial type
Trial population
Recruitment figures
No (%) South Asian
participantsSex Age (years) Recruitment
Hysterectomy Female >18 (mean 41.2 (SD 8)) National 1380 randomised 8 (0.6%)
Cancer:
Colorectal Male and female >18 (mean 69; range 25-94) National 584 on whom ethnicity
data are available
1 (0.2%)
Breast Female
(post-menopausal)
Mean 64 Regional 780 randomised 2 (0.3%)
Breast Female
(post-menopausal)
Most >55 Regional 133 randomised 0 (0%)
Ovarian Female >18* Regional 480 registered
(242 randomised)
3 (0.6%)
National 559 registered
(300 randomised)
4 (0.7%)
Helicobacter pylori
eradication
Male and female 40-49 Regional 8407 participants 145 (1.7%)
Office for National Statistics’ latest estimates of proportion of population that is of South Asian origin are 3.8% for the Yorkshire-Humber region and 3.4% for Great
Britain as a whole.3
*Range and mean unknown.
Papers
Pregnant
women
carrying boys
have a 10%
higher energy
intake than
those carrying
girls
continued over
BMJ 2003;326:1245–6
1245BMJ VOLUME 326 7 JUNE 2003 bmj.com
 on 25 October 2004 bmj.comDownloaded from 


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Representation of South Asian people in randomised clinical trials: analysis of trials' data

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