Quality control on clinical research in the thoracic oncology_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

MAO Yousheng ,  HE Jie , GAO Shugeng , YUAN Ligong , ZHAO Yue , LI Feng , WANG Shuaibo

Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, P.R.China;

Corresponding author：

HE Jie, Email: hejie@cicams.ac.cn

Keywords：

Clinical research; thoracic oncology; quality control

DOI：

10.7507/1007-4848.201907025

Video：

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Abstract Full text Figures/Tables Video References Cited by

This article reviewed other literatures in the quality management of clinical trials and summarized author’s experience in quality control of clinical trials which the author conducted as principle investigator over the past years. It provides a reference for fresh investigators before they conduct their own clinical trials.

Citation： MAO Yousheng, HE Jie, GAO Shugeng, YUAN Ligong, ZHAO Yue, LI Feng, WANG Shuaibo. Quality control on clinical research in the thoracic oncology. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2019, 26(10): 943-946. doi: 10.7507/1007-4848.201907025 Copy

1.	Yang H, Liu H, Chen Y, et al. Neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus (NEOCRTEC5010): A phase Ⅲ multicenter, randomized, open-label clinical trial. J Clin Oncol, 2018, 36(27): 2796-2803.
2.	Mu J, Gao S, Mao Y, et al. Open three-stage transthoracic oesophagectomy versus minimally invasive thoraco-laparoscopic oesophagectomy for oesophageal cancer: protocol for a multicentre prospective, open and parallel, randomised controlled trial. BMJ Open, 2015, 5(11): e008328.
3.	Li B, Hu H, Zhang Y, et al. Extended right thoracic approach compared with limited left thoracic approach for patients with middle and lower esophageal squamous cell carcinoma: three-year survival of a prospective, randomized, open-label trial. Ann Surg, 2018, 267(5): 826-832.
4.	Shao L, Ye T, Ma L, et al. Three-field versus two-field lymph node dissection for thoracic esophageal squamous cell carcinoma: a propensity score-matched comparison. J Thorac Dis, 2018, 10(5): 2924-2932.
5.	龙浩, 林志潮, 司徒冬荣. 电视辅助胸腔镜与小切口开胸肺切除术所致损伤的对照研究. 中华外科杂志, 2008, 46(6): 401-404.
6.	张轶, 姜格宁, 王群, 等. 早期非小细胞肺癌胸腔镜与开胸肺叶切除术后细胞因子变化的随机对照研究. 中华外科杂志, 2010, 48(17): 1285-1288.
7.	孙亚林, 贺佳, 曹阳, 等. 临床数据管理的电子化趋势. 中国新药杂志, 2005, 14(4): 393-395.
8.	陆芳, 翁维良, 高蕊, 等. 基于电子化数据采集和管理的临床研究质量控制的探讨. 中药新药与临床药理, 2012, 23: 226-229.
9.	胡健萍, 谢高强, 姚晨. 临床研究中电子数据质量控制的策略. 中华医学科研管理杂志, 2015, 28(1): 40-43.
10.	赵一鸣. 临床研究质量控制体系设计的目标和原则. 中华医学杂志, 2010, 90(26): 1801-1803.
11.	董卫. 影响临床研究质量的因素及其控制. 中国实用内科杂志, 2006, 26(21): 1754-1755.
12.	Houston L, Probst Y, Martin A, et al. Assessing data quality and the variability of source data verification auditing methods in clinical research settings. J Biomed Inform, 2018, 83: 25-32.
13.	Morrison BW, Cochran CJ, White JG, et al. Monitoring the quality of conduct of clinical trials: a survey of current practices clinical trials. Clin Trials, 2011, 8(3): 342-349.
14.	Weiner MG, Lyman JA, Murphy S, et al. Electronic health records: high-quality electronic data for higher-quality clinical research. Inform Prim Care, 2007, 15(2): 121-127.

1. Yang H, Liu H, Chen Y, et al. Neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus (NEOCRTEC5010): A phase Ⅲ multicenter, randomized, open-label clinical trial. J Clin Oncol, 2018, 36(27): 2796-2803.
2. Mu J, Gao S, Mao Y, et al. Open three-stage transthoracic oesophagectomy versus minimally invasive thoraco-laparoscopic oesophagectomy for oesophageal cancer: protocol for a multicentre prospective, open and parallel, randomised controlled trial. BMJ Open, 2015, 5(11): e008328.
3. Li B, Hu H, Zhang Y, et al. Extended right thoracic approach compared with limited left thoracic approach for patients with middle and lower esophageal squamous cell carcinoma: three-year survival of a prospective, randomized, open-label trial. Ann Surg, 2018, 267(5): 826-832.
4. Shao L, Ye T, Ma L, et al. Three-field versus two-field lymph node dissection for thoracic esophageal squamous cell carcinoma: a propensity score-matched comparison. J Thorac Dis, 2018, 10(5): 2924-2932.
5. 龙浩, 林志潮, 司徒冬荣. 电视辅助胸腔镜与小切口开胸肺切除术所致损伤的对照研究. 中华外科杂志, 2008, 46(6): 401-404.
6. 张轶, 姜格宁, 王群, 等. 早期非小细胞肺癌胸腔镜与开胸肺叶切除术后细胞因子变化的随机对照研究. 中华外科杂志, 2010, 48(17): 1285-1288.
7. 孙亚林, 贺佳, 曹阳, 等. 临床数据管理的电子化趋势. 中国新药杂志, 2005, 14(4): 393-395.
8. 陆芳, 翁维良, 高蕊, 等. 基于电子化数据采集和管理的临床研究质量控制的探讨. 中药新药与临床药理, 2012, 23: 226-229.
9. 胡健萍, 谢高强, 姚晨. 临床研究中电子数据质量控制的策略. 中华医学科研管理杂志, 2015, 28(1): 40-43.
10. 赵一鸣. 临床研究质量控制体系设计的目标和原则. 中华医学杂志, 2010, 90(26): 1801-1803.
11. 董卫. 影响临床研究质量的因素及其控制. 中国实用内科杂志, 2006, 26(21): 1754-1755.
12. Houston L, Probst Y, Martin A, et al. Assessing data quality and the variability of source data verification auditing methods in clinical research settings. J Biomed Inform, 2018, 83: 25-32.
13. Morrison BW, Cochran CJ, White JG, et al. Monitoring the quality of conduct of clinical trials: a survey of current practices clinical trials. Clin Trials, 2011, 8(3): 342-349.
14. Weiner MG, Lyman JA, Murphy S, et al. Electronic health records: high-quality electronic data for higher-quality clinical research. Inform Prim Care, 2007, 15(2): 121-127.

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Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Quality control on clinical research in the thoracic oncology

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