The Changing Landscape of Heart Failure Drug Clinical Trials in China, 2013–2023

Wenjie Zhang,1,2,* Yinming Zhang,3,* Jiawei Tang,4,* Xuejiao Wang,1 Chao Meng,1,2 Ji Wu,1 Jun Li1 1Department of Cardiology, Guang’Anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, People’s Republic of China; 2Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, People’s Republic of China; 3Department of Emergency, Yankuang New Journey General Hospital, Zoucheng, Shandong Province, 273500, People’s Republic of China; 4School of Computer Science, Beijing University of Posts and Telecommunications, Beijing, 100876, People’s Republic of China*These authors contributed equally to this workCorrespondence: Ji Wu, Email [email protected] Jun Li, Email [email protected]: This review aimed to delineate the changing landscape of heart failure (HF) drug clinical trials conducted in China during 2013– 2023.Methods: Detailed information on HF drug trials registered on the National Medical Products Administration Clinical Trial Information Disclosure Platform from January 1, 2013, to December 31, 2023, was collected. The characteristics, drug mechanisms, data safety, participant protection, geographical locations, and scales of HF drug clinical trials were analyzed.Results: China initiated 354 hF drug clinical trials during 2013– 2023, encompassing eight acute heart failure (AHF) trials and 346 trials for chronic heart failure (CHF). The overall number of HF trials continued to increase, whereas the number of AHF trials remained consistently low. Significant differences were observed between AHF and CHF trials regarding trial phases, drug types, trial designs, blinding methods, and geographical coverage. 85.8% CHF trials were bioequivalence studies, whereas AHF trials were exclusively Phase I–III studies. Most trial drugs were chemical drugs, with renin-angiotensin-aldosterone system inhibitors accounting for the highest proportion. Sixteen new drug studies involved 13 different new drugs. The proportion of studies establishing independent data monitoring committees annually remained generally low, whereas the proportion of studies purchasing clinical trial insurance for participants annually exhibited an overall upward trend. The 354 trials were led by principal investigators from 27 provinces, autonomous regions, or municipalities in China. 47.2% leading units for these studies were distributed in the eastern coastal regions of China. There were 30 drug clinical trials with more than ten participating centers and 16 drug clinical trials with a target number of participants of over 1000 individuals.Conclusion: Over the past decade, China has experienced rapid development in HF drug trials, particularly in drug consistency evaluations. All stakeholders involved in drug trials should carefully consider the inadequate innovations in first-in-class drugs.Keywords: heart failure, China, drug clinical trial, changing landscape