A large number of
investigator-initiated clinical trials (IIT) were conducted in
China, some of them should
play an important supporting
role in new
drug development. Due to the large number, small scale and uneven quality of IIT in
China, especially a big gap between the IIT and
industry-sponsored trials in terms of protocol design,
quality management and
ethical review, many IIT can't be used to support the new
drug development. Therefore, it is necessary for regulatory authorities, sponsors,
research institutions,
ethics committees and
researchers to improve their
understanding of the
role of IIT. In order to support the new
drug development with high-quality IIT, formulating supervising system, establishing an effective
quality management system, enhancing the
training of
researchers and improving the
ability of
ethical review should be implemented effectively.
.