Ovarian cancer is one of the main causes of death among gynecological malignancies in China. With the rapid development of antineoplastic therapies worldwide

new drugs are emerging one afrer another in China. Carrying out the relevant clinical studies scientifically and efficiently will bring great benefits to the patients. Based on the stage Ⅰ clinical study of niraparib in China (No. ZL-2306-002)

Chinese experts summarized and discussed it from the perspectives of getting informed consent

auditing patient recruitment

follow-up of clinical medication

data management

adverse reaction management and patient care. Meanwhile

the present condition of stage Ⅰ study of ovarian cancer in China was analyzed

aiming to provide reference and experience for the development of clinical study of novel antineoplastic drugs in China.