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：

Export PDF Favorites Scan Get Citation

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.	龍浩, 林志潮, 司徒冬榮. 電視輔助胸腔鏡與小切口開胸肺切除術所致損傷的對照研究. 中華外科雜志, 2008, 46(6): 401-404.
6.	張軼, 姜格寧, 王群, 等. 早期非小細胞肺癌胸腔鏡與開胸肺葉切除術后細胞因子變化的隨機對照研究. 中華外科雜志, 2010, 48(17): 1285-1288.
7.	孫亞林, 賀佳, 曹陽, 等. 臨床數據管理的電子化趨勢. 中國新藥雜志, 2005, 14(4): 393-395.
8.	陸芳, 翁維良, 高蕊, 等. 基于電子化數據采集和管理的臨床研究質量控制的探討. 中藥新藥與臨床藥理, 2012, 23: 226-229.
9.	胡健萍, 謝高強, 姚晨. 臨床研究中電子數據質量控制的策略. 中華醫學科研管理雜志, 2015, 28(1): 40-43.
10.	趙一鳴. 臨床研究質量控制體系設計的目標和原則. 中華醫學雜志, 2010, 90(26): 1801-1803.
11.	董衛. 影響臨床研究質量的因素及其控制. 中國實用內科雜志, 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. 龍浩, 林志潮, 司徒冬榮. 電視輔助胸腔鏡與小切口開胸肺切除術所致損傷的對照研究. 中華外科雜志, 2008, 46(6): 401-404.
6. 張軼, 姜格寧, 王群, 等. 早期非小細胞肺癌胸腔鏡與開胸肺葉切除術后細胞因子變化的隨機對照研究. 中華外科雜志, 2010, 48(17): 1285-1288.
7. 孫亞林, 賀佳, 曹陽, 等. 臨床數據管理的電子化趨勢. 中國新藥雜志, 2005, 14(4): 393-395.
8. 陸芳, 翁維良, 高蕊, 等. 基于電子化數據采集和管理的臨床研究質量控制的探討. 中藥新藥與臨床藥理, 2012, 23: 226-229.
9. 胡健萍, 謝高強, 姚晨. 臨床研究中電子數據質量控制的策略. 中華醫學科研管理雜志, 2015, 28(1): 40-43.
10. 趙一鳴. 臨床研究質量控制體系設計的目標和原則. 中華醫學雜志, 2010, 90(26): 1801-1803.
11. 董衛. 影響臨床研究質量的因素及其控制. 中國實用內科雜志, 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.

Previous Article
Application of polydioxanone material in surgical field
Next Article
第 74 回日本消化器外科學會總會食管癌治療內容拔萃

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Quality control on clinical research in the thoracic oncology

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content