The development and challenges of Investigator-Initiated Trials (IITs) in China

Investigator-Initiated Trials (IITs) have seen substantial growth in China, particularly in drug and medical device research. IITs are initiated by investigators addressing clinical needs without focus on product registration or marketing, thereby offering flexibility for advancing clinical practices. Despite their potential, IITs in China face challenges, including regulatory ambiguities, funding limitations, quality control issues, and inconsistencies in ethical review processes. This paper examines the current IIT landscape, identifies major obstacles, and proposes solutions, including regulatory reforms, funding increases, ethical review standardization, and international collaboration, to enhance IITs' effectiveness and impact on Chinese clinical research.