The inclusion of minority groups in clinical trials: problems of under representation and under reporting of data.
OBJECTIVE
To evaluate the representation of minority groups in randomized control trials (RCTs), and the frequency with which this information is reported.


METHODS
Reviewers collected data on the racial/ethnic composition of study samples from all RCTs published in six leading medical journals in 1999.


RESULTS
Of the 280 RCTs, most (204, 71.3%) provided no information on the race/ethnicity of participants. Of the 89 U.S.-based RCTs, 50 (56.1%) reported their minority distribution. Relative to other trials, those funded by the National Institute of Health (NIH) (n = 52) were more likely to report race/ethnicity data (55.8% vs. 23.7%; x2 = 20.9, p <_0.001) and to include nonwhite participants (13.5 % vs. 12.5%; x2=22.7, p<_0.001).


CONCLUSIONS
Minority groups are currently under-represented in clinical trials. Information on the race and ethnicity of clinical trial participants is currently underreported in six leading medical journals. Reporting of minority group information was significantly better only in NIH funded trials, which also were more likely to include nonwhite participants. This suggests that mandatory reporting policies may have a positive effect on both reporting and representation.
Rochon
Paula A
PA
Kunin-Lunenfeld Applied Research Unit, Baycrest Centre for Geriatric Care, 3560 Bathurst St., Toronto, ON M6A 2E1, Canada. paula.rochon@utoronto.ca
Mashari
Azad
A
Cohen
Ariel
A
Misra
Anjali
A
Laxer
Dara
D
Streiner
David L
DL
Clark
Jocalyn P
JP
Dergal
Julie M
JM
Gold
Jennifer
J
D005006:Ethnicity; D006801:Humans; D008913:Minority Groups; D009316:National Institutes of Health (U.S.); D010506:Periodicals as Topic; D011643:Publishing; D044469:Racial Groups; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D014481:United States