Racial and ethnic enrollment disparities and demographic reporting requirements in acute leukemia clinical trials.
Racial and ethnic enrollment disparities and demographic reporting requirements in acute leukemia clinical trials.
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DOI：
10.1182/bloodadvances.2021005148
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发表时间：
2021-11-09
期刊：
影响因子：
7.5
通讯作者：
Abel GA
中科院分区：
文献类型：
--
作者：
Hantel A;Luskin MR;Garcia JS;Stock W;DeAngelo DJ;Abel GA
急性白血病试验的公共人口统计报告不充分，并且NH白人受试者更有可能入选。在联邦报告要求之后，记录了更大的种族-民族入学差异，这可能是由于数据更加透明。关于美国急性髓性白血病（AML）和急性淋巴细胞白血病（ALL）临床试验的种族和民族入组多样性的数据有限，并且对21世纪末制定的联邦报告要求的影响知之甚少。我们检查了2002年至2017年美国ALL和AML试验的人口统计数据报告和入组多样性，以及报告要求制定后报告和多样性的变化。在223项AML试验和97项ALL试验中，结果公布在ClinicalTrials.gov上，68项（30.5%）和51项（52.6%）报告了按人种和种族入组。在报告人种和种族的试验中，在调整人种-种族疾病发生率后，与NH-白人患者相比，AML（n = 6554; ALL，n = 4149）、非西班牙裔（NH）-黑人、NH-美洲原住民、NH-亚裔和西班牙裔患者的入组率显著降低（AML比值比分别为0.68、0.31、0.75和0.83; ALL比值比分别为0.74、0.27、0.67和0.64;均P ≤ 0.01）。实施报告要求后，报告人种的试验比例显著增加（44.2%至60.2%; P = 0.02），但人种-种族报告没有增加（34.8%至38.6%; P = 0.57）。在制定报告要求后，根据入组患者数量的报告比例显著增加（种族，51.7%至72.7%;种族-民族，39.5%至45.4%;两者，P <0.001），NH黑人和西班牙裔患者的相对入组率下降（AML比值比，0.79和0.77; ALL比值比，0.35和0.25;均P ≤ 0.01）。这些数据表明，急性白血病试验的人口统计学入组报告是次优的，报告要求后的多样性变化可能是由于以前未报告的额外入组差异，需要针对急性白血病护理提供的入组多样化策略。
Public demographic reporting for acute leukemia trials is inadequate, and NH-White subjects are more likely to be enrolled. Larger racial-ethnic enrollment disparities were documented after federal reporting requirements, which may be from more data transparency. Data regarding racial and ethnic enrollment diversity for acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) clinical trials in the United States are limited, and little is known about the effect of federal reporting requirements instituted in the late 2000s. We examined demographic data reporting and enrollment diversity for ALL and AML trials in the United States from 2002 to 2017, as well as changes in reporting and diversity after reporting requirements were instituted. Of 223 AML trials and 97 ALL trials with results on ClinicalTrials.gov, 68 (30.5%) and 51 (52.6%) reported enrollment by both race and ethnicity. Among trials that reported race and ethnicity (AML, n = 6554; ALL, n = 4149), non-Hispanic (NH)-Black, NH-Native American, NH-Asian, and Hispanic patients had significantly lower enrollment compared with NH-White patients after adjusting for race-ethnic disease incidence (AML odds ratio, 0.68, 0.31, 0.75, and 0.83, respectively; ALL odds ratio, 0.74, 0.27, 0.67, and 0.64; all, P ≤ .01). The proportion of trials reporting race increased significantly after implementation of the reporting requirements (44.2% to 60.2%; P = .02), but race-ethnicity reporting did not (34.8% to 38.6%; P = .57). Reporting proportions according to number of patients enrolled increased significantly after the reporting requirements were instituted (race, 51.7% to 72.7%; race-ethnicity, 39.5% to 45.4%; both, P < .001), and relative enrollment of NH-Black and Hispanic patients decreased (AML odds ratio, 0.79 and 0.77; ALL odds ratio, 0.35 and 0.25; both P ≤ .01). These data suggest that demographic enrollment reporting for acute leukemia trials is suboptimal, changes in diversity after the reporting requirements may be due to additional enrollment disparities that were previously unreported, and enrollment diversification strategies specific to acute leukemia care delivery are needed.
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DOI：
10.1007/s13187-014-0749-0
发表时间：
2015-09
期刊：
Journal of cancer education : the official journal of the American Association for Cancer Education
影响因子：
--
作者：
Farr DE;Brandt HM;Comer KD;Jackson DD;Pandya K;Friedman DB;Ureda JR;Williams DG;Scott DB;Green W;Hébert JR
通讯作者：
Hébert JR
影响因子：
28.2
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Bhatnagar B;Kohlschmidt J;Mrózek K;Zhao Q;Fisher JL;Nicolet D;Walker CJ;Mims AS;Oakes C;Giacopelli B;Orwick S;Boateng I;Blachly JS;Maharry SE;Carroll AJ;Powell BL;Kolitz JE;Stone RM;Byrd JC;Paskett ED;de la Chapelle A;Garzon R;Eisfeld AK
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Eisfeld AK
DOI：
10.1097/coc.0b013e3181dea934
发表时间：
2011-06-01
影响因子：
2.6
作者：
Byrne, Margaret M.;Halman, L. Jill;Cheung, Michael C.
通讯作者：
Cheung, Michael C.
影响因子：
2.3
作者：
Patel, M. I.;Ma, Y.;Rhoads, K. F.
通讯作者：
Rhoads, K. F.
DOI：
10.1093/jncimonographs/lgs019
发表时间：
2012-05-01
期刊：
Journal of the National Cancer Institute. Monographs
影响因子：
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作者：
Clauser, Steven B;Taplin, Stephen H;Kaluzny, Arnold D
通讯作者：
Kaluzny, Arnold D