Revisiting real-world study_Chinese Journal of Evidence-Based Medicine

Authors：

 SUN Xin ^1,2,# , TAN Jing ^1,2,# , TANG Li ^1,2 , YU Chuan ^1,2 , LI Jing ¹ , KANG Deying ¹ , CHEN Jin ¹ , LI Youping ¹

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. International Society for Pharmacoeconomics and Outcomes Research (ISPOR)-West China Chapter, Chengdu, 610041, P.R.China;

Corresponding author：

SUN Xin, Email: sunx79@hotmail.com

Keywords：

DOI：

10.7507/1672-2531.201701088

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Citation： SUNXin, TANJing, TangLi, YUChuan, LIJing, KANGDeying, CHENJin, LIYouping. Revisiting real-world study. Chinese Journal of Evidence-Based Medicine, 2017, 17(2): 126-130. doi: 10.7507/1672-2531.201701088 Copy

1.	ISPOR Connection. Real-life data: A growing need. (Accessed on Jan 23, 2017). Available at: http://www.ispor.org/News/ articles/Oct07/RLD.asp.
2.	U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Draft Guidance for Industry and Food and Drug Administration Staff- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Accessed on Jan 23, 2017). Available at: http://google2.fda.gov/search?q=real+world+study&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*.
3.	Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014. Available at: http://www.effectivehealthcare.ahrq.gov/registries-guide-3.cfm.
4.	Ware JH, Hamel MB. Pragmatic trials-guides to better patient care? N Engl J Med, 2011, 364(18): 1685-1687.
5.	Bhatt DL, Mehta C. Adaptive Designs for Clinical Trials. N Engl J Med, 2016, 375(1): 65-74.
6.	Kontopantelis E, Doran T, Springate DA,et al. Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis. BMJ, 2015, 350: h2750.

1. ISPOR Connection. Real-life data: A growing need. (Accessed on Jan 23, 2017). Available at: http://www.ispor.org/News/ articles/Oct07/RLD.asp.
2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Draft Guidance for Industry and Food and Drug Administration Staff- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Accessed on Jan 23, 2017). Available at: http://google2.fda.gov/search?q=real+world+study&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*.
3. Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014. Available at: http://www.effectivehealthcare.ahrq.gov/registries-guide-3.cfm.
4. Ware JH, Hamel MB. Pragmatic trials-guides to better patient care? N Engl J Med, 2011, 364(18): 1685-1687.
5. Bhatt DL, Mehta C. Adaptive Designs for Clinical Trials. N Engl J Med, 2016, 375(1): 65-74.
6. Kontopantelis E, Doran T, Springate DA,et al. Regression based quasi-experimental approach when randomisation is not an option: interrupted time series analysis. BMJ, 2015, 350: h2750.

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