Trends of Phase I Clinical Trials of New Drugs in Mainland China Over the Past 10 Years (2011-2020).

Chen Chen,Shasha Wang,Ning Lou,Xiaohong Han,Xin Zheng,Haizhu Chen

doi:10.3389/fmed.2021.777698

Abstract

Background: In recent years, the number of clinical trials initiated in China has increased rapidly. The aim of this study was to overview the changing landscape of phase I clinical trials in mainland China from 2011 to 2020.Methods: We analyzed phase I clinical trials registered on 3 websites including the Chinese Clinical Trial Registry, ClinicalTrials.gov, and the China National Medical Products Administration Center for Drug Evaluation platform.Findings: A total of 2,842 phase I clinical trials were posted from January 1, 2011, to December 31, 2020. The overall number of clinical trials for innovative drugs was 1,497, accounting for half of all the phase I clinical trials (53%). Among these 1,486 innovative drug clinical trials, 924 were newly tested drugs with an average annual growth rate of 59%. Biological drug research increased significantly from 22.6% during 2011–2015 to 33.3% during 2016–2020. These principal investigators (PIs) of these clinical trials were mainly from Beijing (n = 871), followed by Shanghai (n = 496) and Jiangsu (n = 281). As for the therapeutic area of phase I clinical trials, cancer took up the most percentage of all the clinical trials (35%), followed by infectious disease (9%), nervous system disease (9%), etc. Most phase I clinical trials are conducted on healthy volunteers (n = 1,642, 57.8%), some cancer drugs are conducted in patients with cancer (n = 846, 29.8%), and only a few clinical trials were conducted in the elderly (n = 7). Among these clinical trials of the newly tested innovative drugs, the first in human (FIH) clinical trials accounted for 82% (744), and the First in Chinese (FIC) clinical trials only took up 18% (167). Only a small number of drugs could be made the transition to phase II (n = 207, 22%). In addition, despite the number of newly tested drugs during 2011–2015 (n = 163) was much less than that in 2016–2020 (n = 761), the percentage of drugs that could enter into phase II clinical trials in 2011–2015 (34%) was higher than that in 2016–2020 (20%).Conclusion: In the past 10 years, the development of phase I clinical trials has achieved great progress in mainland China due to the novel design and drug innovation policy. Nevertheless, future efforts are needed to make for improving the phase transition success rate of innovative drugs.

Highlights

IntroductionIn the past 10 years (2011–2020), following the opportunities created by the availability of many new drugs and substantial increase in the number of patients available to be enrolled in trials, the number of registered clinical trials is increasing [1].Three authoritative clinical trials registration databases are an important resource to view and access clinical trials registration data including the Chinese Clinical Trial Registry (ChiCTR) that was established in 2005 and was assigned to be the representative of China to join the WHO International Clinical Trials Registry Platform (ICTRP) in 2007 [2], the ClinicalTrials.gov that was launched in 2000 and was managed by the National Library of Medicine [3], and the China National Medical Products Administration (NMPA), the former name is the China Food and Drug Administration (CFDA) Registration and Information Disclosure Platform for Drug Clinical Studies, which was established in 2013 [4]
Annual Change of Phase I Clinical Trials A total of 2,842 phase I clinical trials registered on the three public websites from January 1, 2011, to December 31, 2013, in the ClinicalTrials and Chinese Clinical Trial Registry (ChiCTR) and from 2013 in Center for Drug Evaluation (CDE) were available for analysis in this study
The annual number of initiated phase I clinical trials increased over time, with an average annual growth rate of about 37%

Summary

Introduction

In the past 10 years (2011–2020), following the opportunities created by the availability of many new drugs and substantial increase in the number of patients available to be enrolled in trials, the number of registered clinical trials is increasing [1].Three authoritative clinical trials registration databases are an important resource to view and access clinical trials registration data including the Chinese Clinical Trial Registry (ChiCTR) that was established in 2005 and was assigned to be the representative of China to join the WHO International Clinical Trials Registry Platform (ICTRP) in 2007 [2], the ClinicalTrials.gov that was launched in 2000 and was managed by the National Library of Medicine [3], and the China National Medical Products Administration (NMPA), the former name is the China Food and Drug Administration (CFDA) Registration and Information Disclosure Platform for Drug Clinical Studies, which was established in 2013 [4]. Analyzing clinical trials registration data can illuminate important trends over time. A phase I trial represents the critical transition of a novel compound from the preclinical to clinical stage, and provides the foundation for an efficacious drug development program [5]. Phase I clinical trials have evolved from the traditional role of dose and toxicity-finding studies to innovative study designs that match patients with study agents and rely on the model-informed drug development (MIDD), increasing the potential of clinical efficacy, even in the early dose-escalation setting [6]. Analyzing phase I clinical trials registration data of China can give us information about the development of novel therapeutic drugs in China over the past decades and illuminate the trends and developmental directions of medicine in the future years. The number of clinical trials initiated in China has increased rapidly. The aim of this study was to overview the changing landscape of phase I clinical trials in mainland China from 2011 to 2020

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