Global Trial Representation and Availability of Tyrosine Kinase Inhibitors for Treatment of Chronic Myeloid Leukemia

Author:

Casey Mycal1ORCID,Odhiambo Lorriane2,Aggarwal Nidhi3ORCID,Shoukier Mahran4,Islam K. M.25,Cortes Jorge45ORCID

Affiliation:

1. Division of Hematology-Oncology, MedStar Georgetown University Hospital, Washington, DC 20007, USA

2. Department of Biostatistics, Data Science and Epidemiology, Augusta University, Augusta, GA 30912, USA

3. Department of Medicine, Medstar Georgetown University Hospital, Washington, DC 20007, USA

4. Georgia Cancer Center, Augusta University, Augusta, GA 30912, USA

5. Medical College of Georgia, Augusta University, Augusta, GA 30912, USA

Abstract

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.

Publisher

MDPI AG

Reference30 articles.

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