Tejeda H A, Green S B, Trimble E L, Ford L, High J L, Ungerleider R S, Friedman M A, Brawley O W
St. Peter's Medical Center (UMDNJ), Department of Medicine, New Brunswick, NJ 08903-0591, USA.
J Natl Cancer Inst. 1996 Jun 19;88(12):812-6. doi: 10.1093/jnci/88.12.812.
The National Cancer Institute (NCI)-sponsored clinical trials cooperative groups place more than 25 000 American patients in treatment trials every year. Equal access and proportional representation of all races/ethnicities is desired.
Our objectives were to evaluate the inclusion of African-Americans, Hispanics, and non-Hispanic whites in NCI-sponsored treatment trials and to determine if there is proportional racial/ethnic representation.
During the period of January 1, 1991, through June 30, 1994, 99 495 cancer patients were enrolled in clinical trials and declared themselves as non-Hispanic black, non-Hispanic white, or Hispanic (of any race). In the analysis, participants in NCI treatment trials were subdivided into three age groups: birth to 19 years, 20-49 years, and 50 or more years. The racial/ethnic composition of each of these age groups was compared with the racial/ethnic makeup of the American population with cancer. Estimates of the number of incident cancer cases per year were made for each racial/ethnic group within each age group using data from the Surveillance, Epidemiology, and End Results (SEER) Program and the 1990 Census. The percentage of all cancer patients who were in each racial/ethnic group were compared with the population that entered clinical trials. Comparisons are also made separately for patients with leukemia and breast, colorectal, lung, and prostate cancers.
Among patients 0-19 years old, 20-49 years old, and 50 years old or older there is relatively proportional representation of non-Hispanic blacks, Hispanics, and non-Hispanic whites in trials. It is noted that more than 70% of cancer patients aged 0-19 years are estimated to enter cooperative group clinical trials compared with 4.0% of cancer patients aged 20-49 years and 1.5% of patients aged 50 years or older.
Accrual of American cancer patients to NCI-sponsored treatment trials generally parallels the incident burden of disease among non-Hispanic African-Americans, Hispanics, and non-Hispanic whites.
This study shows that the NCI clinical trials are, as a whole, racially/ethnically representative of the American population and suggests that there is equal access to NCI clinical trials.
美国国立癌症研究所（NCI）资助的临床试验合作组每年让超过25000名美国患者参与治疗试验。希望所有种族/族裔都能有平等的参与机会和按比例的代表权。
我们的目标是评估非裔美国人、西班牙裔和非西班牙裔白人参与NCI资助的治疗试验的情况，并确定种族/族裔代表权是否成比例。
在1991年1月1日至1994年6月30日期间，99495名癌症患者参与了临床试验，并表明自己为非西班牙裔黑人、非西班牙裔白人或西班牙裔（任何种族）。在分析中，参与NCI治疗试验的患者被细分为三个年龄组：出生至19岁、20 - 49岁和50岁及以上。将这些年龄组中每一组的种族/族裔构成与美国癌症患者的种族/族裔构成进行比较。使用监测、流行病学和最终结果（SEER）计划以及1990年人口普查的数据，对每个年龄组内每个种族/族裔群体每年的新发癌症病例数进行估计。将每个种族/族裔群体中所有癌症患者的百分比与进入临床试验的人群进行比较。还分别对白血病患者以及乳腺癌、结直肠癌、肺癌和前列腺癌患者进行了比较。
在0 - 19岁、20 - 49岁和50岁及以上的患者中，试验中非西班牙裔黑人、西班牙裔和非西班牙裔白人的代表性相对成比例。值得注意的是，估计0 - 19岁的癌症患者中有超过70%进入合作组临床试验，而20 - 49岁的癌症患者中这一比例为4.0%，50岁及以上患者中这一比例为1.5%。
美国癌症患者参与NCI资助的治疗试验的情况总体上与非西班牙裔非裔美国人、西班牙裔和非西班牙裔白人中的疾病发病负担相当。
这项研究表明，NCI的临床试验总体上在种族/族裔方面代表了美国人群，并表明参与NCI临床试验的机会是平等的。
