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.	Id?np??n-Heikkil? 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.	中國國家市場監督管理總局. 國家市場監督管理總局關于公開征求《藥物臨床試驗質量管理規范(修訂草案征求意見稿)》意見的通知. 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, 喻佳潔, 等. 實效性隨機對照試驗: 真實世界研究的重要設計. 中國循證醫學雜志, 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.	譚婧, 程亮亮, 王雯, 等. 患者登記研究的策劃與患者登記數據庫構建:基于觀察性設計的真實世界研究. 中國循證醫學雜志, 2017, 17(12): 1365-1372.
13.	王雯, 劉艷梅, 譚婧, 等. 回顧性數據庫研究的概念、策劃與研究數據庫構建. 中國循證醫學雜志, 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.	岳曉萌, 郭心怡, 萬敬員, 等. 從普納替尼撤市再上市談歐美藥品風險管理. 中國藥物警戒, 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, 魏來, 賈繼東, 等. 觀察性臨床研究是隨機對照臨床研究的重要補充. 中華肝臟病雜志, 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. Id?np??n-Heikkil? 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. 中國國家市場監督管理總局. 國家市場監督管理總局關于公開征求《藥物臨床試驗質量管理規范(修訂草案征求意見稿)》意見的通知. 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, 喻佳潔, 等. 實效性隨機對照試驗: 真實世界研究的重要設計. 中國循證醫學雜志, 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. 譚婧, 程亮亮, 王雯, 等. 患者登記研究的策劃與患者登記數據庫構建:基于觀察性設計的真實世界研究. 中國循證醫學雜志, 2017, 17(12): 1365-1372.
13. 王雯, 劉艷梅, 譚婧, 等. 回顧性數據庫研究的概念、策劃與研究數據庫構建. 中國循證醫學雜志, 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. 岳曉萌, 郭心怡, 萬敬員, 等. 從普納替尼撤市再上市談歐美藥品風險管理. 中國藥物警戒, 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, 魏來, 賈繼東, 等. 觀察性臨床研究是隨機對照臨床研究的重要補充. 中華肝臟病雜志, 2015, 23(5): 389-392.

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