1. Global Trial Representation and Availability of Tyrosine Kinase Inhibitors for Treatment of Chronic Myeloid Leukemia.
- Author
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Casey, Mycal, Odhiambo, Lorriane, Aggarwal, Nidhi, Shoukier, Mahran, Islam, K. M., and Cortes, Jorge
- Subjects
PROTEIN-tyrosine kinase inhibitors ,CLINICAL trials ,LIFE expectancy ,CHRONIC myeloid leukemia ,WORLD health ,DRUG approval ,PEOPLE with disabilities - Abstract
Simple Summary: We aimed to evaluate the extent to which clinical trials represent countries with different socio-demographic indexes and the availability of tyrosine kinase inhibitors for chronic myeloid leukemia. We found a significant lack of availability for tyrosine kinase inhibitors on the global level, and a lack of equitable distribution of trials across countries is an issue that needs to be addressed. Background: Evaluating clinical trial representation for countries with different socio-demographic index (SDI) and tyrosine kinase inhibitor (TKI) availability for chronic myeloid leukemia (CML). Methods: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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