Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer

doi:10.19401/j.cnki.1007-3639.2019.05.001

China Oncology ›› 2019, Vol. 29 ›› Issue (5): 321-327.doi: 10.19401/j.cnki.1007-3639.2019.05.001

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Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer

WU Xiaohua¹, ZHANG Jian², YIN Rutie³, LOU Ge⁴, GAO Yunong⁵

1. Department of Gynecological Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; 2. Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China; 3. Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China; 4. Department of Gynecology, the Affiliated Tumor Hospital of Harbin Medical University, Harbin 150081, Heilongjiang Province, China; 5. Department of Gynecological Oncology, Beijing Cancer Hospital, Beijing 100142, China

Online:2019-05-30 Published:2019-06-03
Contact: WU Xiaohua E-mail: wu.xh@fudan.edu.cn

Abstract

Abstract: 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.

Key words: Ovarian cancer, Stage Ⅰ clinical study management, Chinese expert experience

WU Xiaohua, ZHANG Jian, YIN Rutie, LOU Ge, GAO Yunong. Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer[J]. China Oncology, 2019, 29(5): 321-327.

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Chinese expert experience in optimizing stage Ⅰ clinical study management of ovarian cancer

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