Ethical review of real world studies_Chinese Journal of Evidence-Based Medicine

Authors：

LI Hong ^1,2 , WEI Lai ³ , GUO Xiaohui ⁴ , WU Jiuhong ⁵ , YAO Chen ⁶ ,  SUN Xin ⁷

1. James L. Winkle College of Pharmacy Cincinnati University, Cincinnati, 45221-0041, USA;
2. School of Public Health, Shanghai JiaoTong University, Shanghai, 200025, P.R.China;
3. Peking University Hepatology Institute, Beijing, 100044, P.R.China;
4. Peking University First Hospital, Beijing, 100034, P.R.China;
5. 306 Hospital of PLA, Beijing, 100101, P.R.China;
6. Peking University First Hospital, Beijing, 100034, P.R.China;
7. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

SUN Xin, Email: sunx79@hotmail.com

Keywords：

Medical ethics review; Real world study

DOI：

10.7507/1672-2531.201807145

Video：

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Recently, real world studies (RWS) have received increasing attentions. Such studies typically involve patient information, and their results may have potentially significant impact on patient well-being and safety. When reviewing the protocol of real world studies, ethical issues should be carefully considered and assessed. This paper discussed three issues, including the overview of bioethics and its application to classic clinical trials, key features of RWS, and medical ethical considerations on RWS.

Citation： LI Hong, WEI Lai, GUO Xiaohui, WU Jiuhong, YAO Chen, SUN Xin. Ethical review of real world studies. Chinese Journal of Evidence-Based Medicine, 2018, 18(11): 1198-1202. doi: 10.7507/1672-2531.201807145 Copy

1.	Wikipedia the Free Encyclopedia. Declaration of Helsinki 2018. Available at: https://en.wikipedia.org/wiki/Declaration_of_Helsinki.
2.	World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 2013, 310(20): 2191-2194.
3.	International conference on harmonisation. Ich harmonised tripartite guideline guideline for good clinical practice. 1996.
4.	Idänpään-Heikkilä JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med, 1994, 26(2): 89-94.
5.	中国国家市场监督管理总局. 国家市场监督管理总局关于公开征求《药物临床试验质量管理规范(修订草案征求意见稿)》意见的通知. 2018.
6.	Kabisch M, Ruckes C, Seibert-Grafe M, et al. Randomized controlled trials: part 17 of a series on evaluation of scientific publications. Dtsch Arztebl Int, 2011, 108(39): 663-668.
7.	Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med, 2016, 375(23): 2293-2297.
8.	Turner A. Ethical issues raised by big data and real world evidence projects. Oxford Internt Institute, University of Oxford, 2017.
9.	Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the Joint ISPOR-ISPE special task force on real-world evidence in health care decision making. Value Health, 2017, 20(8): 1003-1008.
10.	唐立, 康德英, 喻佳洁, 等. 实效性随机对照试验: 真实世界研究的重要设计. 中国循证医学杂志, 2017, 17(9): 999-1004.
11.	Hemkens LG, Contopoulosioannidis DG, Ioannidis JPA. Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey. BMJ, 2016, 352: i493.
12.	谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建:基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1372.
13.	王雯, 刘艳梅, 谭婧, 等. 回顾性数据库研究的概念、策划与研究数据库构建. 中国循证医学杂志, 2018, 18(2): 230-237.
14.	Wang S, Liu B, Xiong N, et al. Discussion of solutions to ethical issues in real-world study. Front Med, 2014, 8(3): 316-320.
15.	岳晓萌, 郭心怡, 万敬员, 等. 从普纳替尼撤市再上市谈欧美药品风险管理. 中国药物警戒, 2017, 14(4): 218-221.
16.	Laine C, Horton R, DeAngelis CD, et al. Clinical trial registration: looking back and moving ahead. Lancet, 2007, 369(9577): 1909-1911.
17.	Williams RJ, Tse T, Harlan WR, et al. Registration of observational studies: is it time? CMAJ, 2010, 182(15): 1638-1642.
18.	李洪, 魏来, 贾继东, 等. 观察性临床研究是随机对照临床研究的重要补充. 中华肝脏病杂志, 2015, 23(5): 389-392.

1. Wikipedia the Free Encyclopedia. Declaration of Helsinki 2018. Available at: https://en.wikipedia.org/wiki/Declaration_of_Helsinki.
2. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 2013, 310(20): 2191-2194.
3. International conference on harmonisation. Ich harmonised tripartite guideline guideline for good clinical practice. 1996.
4. Idänpään-Heikkilä JE. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med, 1994, 26(2): 89-94.
5. 中国国家市场监督管理总局. 国家市场监督管理总局关于公开征求《药物临床试验质量管理规范(修订草案征求意见稿)》意见的通知. 2018.
6. Kabisch M, Ruckes C, Seibert-Grafe M, et al. Randomized controlled trials: part 17 of a series on evaluation of scientific publications. Dtsch Arztebl Int, 2011, 108(39): 663-668.
7. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-World Evidence - What Is It and What Can It Tell Us? N Engl J Med, 2016, 375(23): 2293-2297.
8. Turner A. Ethical issues raised by big data and real world evidence projects. Oxford Internt Institute, University of Oxford, 2017.
9. Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness: recommendations from the Joint ISPOR-ISPE special task force on real-world evidence in health care decision making. Value Health, 2017, 20(8): 1003-1008.
10. 唐立, 康德英, 喻佳洁, 等. 实效性随机对照试验: 真实世界研究的重要设计. 中国循证医学杂志, 2017, 17(9): 999-1004.
11. Hemkens LG, Contopoulosioannidis DG, Ioannidis JPA. Agreement of treatment effects for mortality from routinely collected data and subsequent randomized trials: meta-epidemiological survey. BMJ, 2016, 352: i493.
12. 谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建:基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1372.
13. 王雯, 刘艳梅, 谭婧, 等. 回顾性数据库研究的概念、策划与研究数据库构建. 中国循证医学杂志, 2018, 18(2): 230-237.
14. Wang S, Liu B, Xiong N, et al. Discussion of solutions to ethical issues in real-world study. Front Med, 2014, 8(3): 316-320.
15. 岳晓萌, 郭心怡, 万敬员, 等. 从普纳替尼撤市再上市谈欧美药品风险管理. 中国药物警戒, 2017, 14(4): 218-221.
16. Laine C, Horton R, DeAngelis CD, et al. Clinical trial registration: looking back and moving ahead. Lancet, 2007, 369(9577): 1909-1911.
17. Williams RJ, Tse T, Harlan WR, et al. Registration of observational studies: is it time? CMAJ, 2010, 182(15): 1638-1642.
18. 李洪, 魏来, 贾继东, 等. 观察性临床研究是随机对照临床研究的重要补充. 中华肝脏病杂志, 2015, 23(5): 389-392.

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