Casey Mycal, Odhiambo Lorriane, Aggarwal Nidhi, Shoukier Mahran, Islam K M, Cortes Jorge
Division of Hematology-Oncology, MedStar Georgetown University Hospital, Washington, DC 20007, USA.
Department of Biostatistics, Data Science and Epidemiology, Augusta University, Augusta, GA 30912, USA.
Cancers (Basel). 2024 Aug 14;16(16):2838. doi: 10.3390/cancers16162838.
: Evaluating clinical trial representation for countries with different socio-demographic index (SDI) and tyrosine kinase inhibitor (TKI) availability for chronic myeloid leukemia (CML). : CML incidence rates (IRs) and disability-adjusted life years (DALYs) (1999-2019) from the Institute of Health Metrics and Evaluation were analyzed. Trials investigating TKI use in CML were obtained from ClinicalTrials.gov. Site data for eligible trials (N = 30) and DALYs were analyzed. TKI approvals, DALYs, and IRs were summarized by SDI. : North America (NA) had significant decreases in annual percent change (APC) in DALYs and incidence rates from 1999 to 2004. IRs were highest in Europe and Central Asia (ECA) and NA, while DALYs were highest in South Asia (SAsia) and Sub-Saharan Africa (SSA). Countries in the high-SDI quintile were likely to have lower DALYs than lower-SDI quintiles. Differences in regional DALYs vs. sites in TKI trials were significant for SAsia, SSA, and ECA. High-SDI countries were included in all 30 trials, and TKI approvals were prominent in high-SDI (142) vs. low-SDI (14) countries. The inclusion of disproportionately affected countries during the design of and recruitment into clinical trials should occur, as should TKI availability. The lack of representation demonstrates healthcare disparities.
评估不同社会人口指数（SDI）国家的临床试验代表性以及慢性髓性白血病（CML）酪氨酸激酶抑制剂（TKI）的可及性。：分析了健康指标与评估研究所提供的1999 - 2019年CML发病率（IRs）和伤残调整生命年（DALYs）。从ClinicalTrials.gov获取了研究TKI在CML中应用的试验。对符合条件的试验（N = 30）的地点数据和DALYs进行了分析。按SDI总结了TKI批准情况、DALYs和IRs。：1999年至2004年，北美（NA）的DALYs和发病率的年度百分比变化（APC）显著下降。欧洲和中亚（ECA）以及北美（NA）的IRs最高，而南亚（SAsia）和撒哈拉以南非洲（SSA）的DALYs最高。高SDI五分位数国家的DALYs可能低于低SDI五分位数国家。南亚、撒哈拉以南非洲和欧洲及中亚地区DALYs与TKI试验地点之间的差异显著。所有30项试验都纳入了高SDI国家，高SDI国家（142项）的TKI批准比低SDI国家（14项）更为突出。在临床试验的设计和招募过程中，应纳入受影响程度不成比例的国家，TKI的可及性也应如此。代表性的缺乏表明了医疗保健方面的差异。
