To provide reference for improving the management of innovative drug clinical trial in China.

From the perspective of the project whole life cycle, this paper analyzes the complex project system of innovative drug clinical trials, discusses the measures and regulatory experience in promoting the development of innovative drug clinical trials in the United States, hoping the suggestions were useful for China.

The process of innovative drug clinical trial projects is complex and the interests of different subjects are different, therefore certain regulatory difficulties exist. Through timely promulgation of various modern regulatory program and clinical trial guidance documents, the United States has promoted the rigor and efficiency of innovative drug clinical trials in the whole life cycle process of protocol design, review and approval, study start-up, ethical review, and data sharing. It is suggested that China should optimize the management path of innovative drug clinical trials from the following aspects, and explore the "master protocol" trial design model to provide further guarantee for clinical trials of new therapies: initiating operation procedures based on optimized trial, applying parallel mechanism of independent review and specialized ethical review, and using diversified data sharing models, in order to ensure efficient clinical trials. The review information disclosure and stakeholder communication mechanism should be constantly improved to strengthen the guidance of innovative drug clinical trial project.