The Establishment and Operation of Steering Committee in Large-scale Clinical Trials of Infertility_Chinese Journal of Evidence-Based Medicine

Authors：

 WANGYu ¹ , GAOJing-shu ¹ , MAHong-li ¹ , CHANGHui ¹ , LIUJian-ping ² , WUTai-xiang ³ , WANGGui-yuan ¹ , DINGCai-fei ⁴ , FUPing ⁵ ,  WUXiao-ke ¹

1. Department of Gynecology and Obstetrics, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China;
2. Center for Evidence-based Medicine, Beijing University of Chinese Medicine, Beijing 100029, China;
3. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;
4. Department of Reproduction, Zhejiang Hospital of Traditional Chinese and Western Medicine, Hangzhou 310003, China;
5. Department of Gynecology and Obstetrics, Hangzhou Hospital of Chinese Medicine, Hangzhou 310007, China;

Corresponding author：

WUXiao-ke, Email: xiaokewu2002@vip.sina.com

Keywords：

Steering committee; Protocol optimization; Quality control; Scientific research output

DOI：

10.7507/1672-2531.20160133

Video：

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High quality clinical trial depends on the preliminary research design and optimizing, the quality control in the medium term, the source data verification and statistics in later stages. Steering committee (SC) can meet above requirements. According to the characteristics of the research project, we invited international experts whose professional background are obstetrics and gynecology, statistics and methodology to set up SC. SC will hold regular conference, the content of the conference included project progress and quality control, research assistant training and assessment, conducting knowledge lectures and so on. The establishment of SC ensured the protocol maneuverability, answered PCOS related problems from different professional perspectives, and solved the problems such as how to improve the scientific research output. At the same time, it provides a platform of scientific research practice and self-improvement. It has profound influence on standardizing the management of the clinical trial, strengthening the consciousness of team work, promoting multi-disciplinary team cooperation, expanding scientific research thinking and cultivating clinical research talent.

Citation： WANGYu, GAOJing-shu, MAHong-li, CHANGHui, LIUJian-ping, WUTai-xiang, WANGGui-yuan, DINGCai-fei, FUPing, WUXiao-ke. The Establishment and Operation of Steering Committee in Large-scale Clinical Trials of Infertility. Chinese Journal of Evidence-Based Medicine, 2016, 16(7): 864-868. doi: 10.7507/1672-2531.20160133 Copy

1.	李博, 高蕊, 李睿, 等.药物临床试验机构专家委员会运行模式探讨.中国新药杂志, 2015, 24(19):2188-2196.
2.	匡洪影, 张跃辉, 吴效科, 等.针刺联合克罗米芬对多囊卵巢综合征妇女活产率影响临床研究设计与实施的探讨.世界科学技术-中医药现代化, 2013, 5(15):864-867.
3.	Kuang H, Li Y, Wu X, et al. Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome:study design of a randomized controlled trial. Evid Based Complement Alternat Med, 2013, 2013:527303.
4.	翁维良, 易丹辉.中医临床研究质量控制与评估.北京:人民卫生出版社, 2014:127-133.
5.	Legro RS, Barnhart HX, Schlaff WD, et al. Clomiphene, Metformin, or Both for Infertility in the Polycystic Ovary Syndrome. N Engl J Med, 2007, 356(6):551-556.
6.	Legro RS, Brzyski RG, Diamond MP, et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med, 2014, 371(2):119-129.
7.	Stener-Victorin E, Waldenstrom U, Tagnfors U, et al. Effects of electro-acupuncture on anovulationin women with polycystic ovary syndrome. Acta Obstet Gynecol Scand, 2000, 79(3):180-188.
8.	Stener-Victorin E, Wu X. Effects and mechanisms of acupuncture in the reproductive system. AutonNeurosci, 2010, 28, 157(1-2):46-51.
9.	Feng Y, Johansson J, Shao R, et al. Hypothalamic neuroendocrine functions in rats with dihydrotestosterone-induced polycystic ovary syndrome:effects of low-frequency electro-acupuncture. PLoS One, 2009, 4(8):e6638.
10.	MacPherson H, Altman DG, Hammerschlag R, et al. Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA):extending the CONSORT statement. PLoS Med, 2010, 7(6):e1000261.
11.	MacPherson H, Altman DG, Hammerschlag R, et al.针刺临床试验干预措施报告标准修订版:CONSORT声明的扩展.中国循证医学杂志, 2010, 10(10):1228-1239.
12.	孙塑伦, 翁维良, 杨龙会, 主编.中医临床研究实施过程质控与管理.北京:中国中医药出版社, 2010:149-177.
13.	Harbin Consensus Conference Workshop Group. Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT):modifying the CONSORT statement. Fertil Steril, 2014, 102(4):952-959.
14.	Harbin Consensus Conference Workshop Group. Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT):modifying the CONSORT statement. Hum Reprod, 2014, 29(10):2075-2082.
15.	戴国华, 张伯礼, 郭治昕.多中心临床试验的研究者培训.中国新药杂志, 2007, 16(11):825-828.
16.	沈文娟, 吴效科, 刘建平.中医药多中心随机对照试验实施过程质量控制的经验体会.现代中医临床, 2014, 21(3):23-25.
17.	梁伟雄, 王奇, 温泽淮, 等.中医临床研究方案设计优化的常见问题与对策.广州中医药大学学报, 2008, 25(5):381-384.
18.	吴泰相, 李幼平, 卞兆祥, 等.实施临床试验报告规范, 提高临床试验透明度.中国循证医学杂志, 2007, 7(8):551-554.
19.	李廷谦, 王刚, 王蕾, 等.我国中医药临床研究的现状和评价.中国循证医学杂志, 2005, 6(5):431-437.
20.	胡敏, 刘建平, 吴效科.针刺临床试验发表国际高影响因子论文的思考.中国中西医结合杂志, 2014, 12(34):1413-1416.
21.	王青, 马红丽, 吴效科.中医临床试验国际论文产出策略.中国中西医结合杂志, 2014, 9(34):1144-1148.

1. 李博, 高蕊, 李睿, 等.药物临床试验机构专家委员会运行模式探讨.中国新药杂志, 2015, 24(19):2188-2196.
2. 匡洪影, 张跃辉, 吴效科, 等.针刺联合克罗米芬对多囊卵巢综合征妇女活产率影响临床研究设计与实施的探讨.世界科学技术-中医药现代化, 2013, 5(15):864-867.
3. Kuang H, Li Y, Wu X, et al. Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome:study design of a randomized controlled trial. Evid Based Complement Alternat Med, 2013, 2013:527303.
4. 翁维良, 易丹辉.中医临床研究质量控制与评估.北京:人民卫生出版社, 2014:127-133.
5. Legro RS, Barnhart HX, Schlaff WD, et al. Clomiphene, Metformin, or Both for Infertility in the Polycystic Ovary Syndrome. N Engl J Med, 2007, 356(6):551-556.
6. Legro RS, Brzyski RG, Diamond MP, et al. Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med, 2014, 371(2):119-129.
7. Stener-Victorin E, Waldenstrom U, Tagnfors U, et al. Effects of electro-acupuncture on anovulationin women with polycystic ovary syndrome. Acta Obstet Gynecol Scand, 2000, 79(3):180-188.
8. Stener-Victorin E, Wu X. Effects and mechanisms of acupuncture in the reproductive system. AutonNeurosci, 2010, 28, 157(1-2):46-51.
9. Feng Y, Johansson J, Shao R, et al. Hypothalamic neuroendocrine functions in rats with dihydrotestosterone-induced polycystic ovary syndrome:effects of low-frequency electro-acupuncture. PLoS One, 2009, 4(8):e6638.
10. MacPherson H, Altman DG, Hammerschlag R, et al. Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA):extending the CONSORT statement. PLoS Med, 2010, 7(6):e1000261.
11. MacPherson H, Altman DG, Hammerschlag R, et al.针刺临床试验干预措施报告标准修订版:CONSORT声明的扩展.中国循证医学杂志, 2010, 10(10):1228-1239.
12. 孙塑伦, 翁维良, 杨龙会, 主编.中医临床研究实施过程质控与管理.北京:中国中医药出版社, 2010:149-177.
13. Harbin Consensus Conference Workshop Group. Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT):modifying the CONSORT statement. Fertil Steril, 2014, 102(4):952-959.
14. Harbin Consensus Conference Workshop Group. Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT):modifying the CONSORT statement. Hum Reprod, 2014, 29(10):2075-2082.
15. 戴国华, 张伯礼, 郭治昕.多中心临床试验的研究者培训.中国新药杂志, 2007, 16(11):825-828.
16. 沈文娟, 吴效科, 刘建平.中医药多中心随机对照试验实施过程质量控制的经验体会.现代中医临床, 2014, 21(3):23-25.
17. 梁伟雄, 王奇, 温泽淮, 等.中医临床研究方案设计优化的常见问题与对策.广州中医药大学学报, 2008, 25(5):381-384.
18. 吴泰相, 李幼平, 卞兆祥, 等.实施临床试验报告规范, 提高临床试验透明度.中国循证医学杂志, 2007, 7(8):551-554.
19. 李廷谦, 王刚, 王蕾, 等.我国中医药临床研究的现状和评价.中国循证医学杂志, 2005, 6(5):431-437.
20. 胡敏, 刘建平, 吴效科.针刺临床试验发表国际高影响因子论文的思考.中国中西医结合杂志, 2014, 12(34):1413-1416.
21. 王青, 马红丽, 吴效科.中医临床试验国际论文产出策略.中国中西医结合杂志, 2014, 9(34):1144-1148.

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