Characteristics and Trends in Clinical Trials of Cardiovascular Drugs in China from 2009 to 2021.

Abstract

Cardiovascular disease remains the leading cause of death worldwide and brings a heavy burden. However, the development of cardiovascular drug clinical trials in China remains unclear. The purpose of this study was to identify the status of clinical trials of cardiovascular drugs in China and provide a reference for stakeholders' decisions. Data were collected from the National Medical Products Administration (NMPA) Registration and Information Disclosure Platform for Drug Clinical Trials before July 1, 2021. We collected all information about clinical trials, including study design, and leading unit. The landscape of cardiovascular drug clinical trials was analyzed by the characteristics, time trends, indications, and geographical distribution. A total of 1666 cardiovascular drug clinical trials were launched from 2009 to 2021 in China. Bioequivalence/bioavailability studies accounted for the most significant proportion (1099 [65.97%]), followed by phase I (296 [17.77%]), phase III (135 [8.10%]), phase II (118 [7.08%]), and phase IV trials (18 [1.08%]). Initiated trials increased by 23.45% annually from 2009 to 2020. Trials of hypertension accounted for the most significant number, followed by coronary heart disease, dyslipidemia, and heart failure. Most trials (66.68%) were conducted in eastern China, followed by the central and western regions, showing a regional disparity as leading units. Despite the significant progress of cardiovascular drug clinical trials in China, there is still a long way to innovative drug research and development, requiring persistent policy support and more investment. Innovation, quality, efficiency, and equity need to be carefully considered by all stakeholders in clinical trials.