Current clinical trials on breast cancer in China: A systematic literature review.

Abstract

With rapid advancement in clinical research, clinical trials on breast cancer in China have made great progress and are increasingly receiving worldwide recognition. Oncologists have been provided with an unprecedented opportunity to conduct clinical trials that offer both advantages and challenges. Investigator-initiated trials (IITs) and trials on domestic innovative drugs are still in the initial stages, with plenty of room to grow. The goal of this study was to systematically review time trends of the changing landscape of clinical drug development in China over the course of the last decade (from 2009 to 2018). The number of clinical trials specific to breast cancer has increased in a span of 10 years, from 36 trials in 2009 to 113 in 2018, and this trend is accompanied by an increase in publications, from 13 in 2009 to 52 in 2015. A total of 593 trials were conducted in breast cancer between 2009 and 2018. The distribution pattern of trial phases shows that phase 2 trials accounted for 34% of the total, followed by phase 3 trials at 21% and phase 1 trials at 20%. Academic trials or IITs were found to be the major sponsors, with 52% of trials being sponsored by them followed by pharmaceutical companies as a secondary sponsor (38%). Additionally, trials on chemotherapeutic agents constituted 50% of the trials followed by trials on targeted therapy (31%). The review provides insight on the effectiveness of the pharmaceutical industry and identify unmet clinical needs of stakeholders. With accumulated experience of Chinese oncologists and increasing support from the Chinese government, greater success could be anticipated in the near future.