Welcome to visit Zhongnan Medical Journal Press Series journal website!
Zhongnan Medical Journal Press Series of Journals Center for Evidence-Based and Translational Medicine of Wuhan University

The title
  • The title
  • The keywords
  • The author
Submit
Home Articles Vol 35,2026 No.6 Detail

Interpretation of the Transparent Reporting of Observational Studies Emulating a Target Trial (TARGET) statement

Published on Jun. 29, 2026Total Views: 45 times Total Downloads: 9 times Download Mobile

Author: LIN Tengfei 1, 2 WU Xiaoyu 3 HE Na 4 LONG Yujun 5 YANG Nan 6 QIU Yijin 7 ZHANG Tiantian 1, 7 XU Yang 3 YANG Zhirong 5, 8

Affiliation: 1.School of Pharmaceutical Sciences, Southern Medical University, Guangzhou 510515, China 2.Research Center for Biomedical Information Technology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen 518055, Guangdong Province, China 3.Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences,Peking University, Beijing 100191, China 4.Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China 5.Department of Computational Biology and Medical Big Data, Faculty of Computer Science and Artificial Intelligence, Shenzhen University of Advanced Technology, Shenzhen 518107, Guangdong Province, China 6.West China School of Pharmacy, Sichuan University, Chengdu 610041, China 7.College of Pharmacy, Jinan University, Guangzhou 511436, China 8.Center for AI in Medicine, Artificial Intelligence Research Institute, Shenzhen University of Advanced Technology, Shenzhen 518107, Guangdong Province, China

Keywords: Observational study Target trial emulation Reporting guideline TARGET statement Causal inference

DOI: 10.12173/j.issn.1005-0698.202512072

Reference: Lin TF, Wu XY, He N, et al. Interpretation of the Transparent Reporting of Observational Studies Emulating a Target Trial (TARGET) statement[J]. Chinese Journal of Pharmacoepidemiology, 2026, 35(6): 613-624. DOI: 10.12173/j.issn.1005-0698.202512072.[Article in Chinese]

  • Abstract
  • Full-text
  • References
Abstract

Given the proliferation of observational studies emulating a target trial, the establishment of standardized and transparent reporting guidelines has become critical. In September 2025, an international expert panel simultaneously published the Transparent Reporting of Observational Studies Emulating a Target Trial (TARGET) statement in JAMA and BMJ. This guideline provides guidance for standardized reporting of observational studies that emulate parallel-group, individually randomized target trials with adjustment for baseline confounders. The TARGET statement comprises a 21-item checklist covering six sections: Abstract, Introduction, Methods, Results, Discussion, and Other Information. This study provides a systematic interpretation of the background and development process of the TARGET statement, illustrates its core items with practical examples, and compares it with established reporting guidelines for observational studies, specifically the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement. The objective of this study is to facilitate a thorough understanding and correct application of the TARGET statement among researchers in China, thereby enhancing the completeness and transparency of reporting for such studies and fostering high-quality research in this domain.

Full-text
Please download the PDF version to read the full text: download
References

1. CollinsR, BowmanL, LandrayM, et al. The magic of randomization versus the myth of real-world evidence[J]. N Engl J Med, 2020, 382(7): 674-678. DOI: 10.1056/NEJMsb1901642.

2. 王雯, 谭婧, 任燕, 等. 重新认识真实世界数据研究:更新与展望[J]. 中国循证医学杂志, 2020, 20(11): 1241-1246.WangW, TanJ, RenY, et al. Real-world data studies: update and future development[J]. Chinese Journal of Evidence-Based Medicine, 2020, 20(11): 1241-1246. DOI: 10.7507/1672-2531.202006183.

3. 孙凤, 高乐, 杨智荣, 等. 偏倚风险评估系列:(五)非随机干预性研究[J]. 中华流行病学杂志, 2018, 39(3): 374-381.SunF, GaoL, YangZR, et al. Series of risk of bias assessment (5): Risk Of Bias In Non-randomized Studies-of Interventions (ROBINS-I)[J]. Chinese Journal of Epidemiology, 2018, 39(3): 374-381. DOI: 10.3760/cma.j.issn.0254-6450.2018.03.024.

4. HernánMA, RobinsJM. Using big data to emulate a target trial when a randomized trial is not available[J]. Am J Epidemiol, 2016, 183(8): 758-764. DOI: 10.1093/aje/kwv254.

5. HernánMA, SauerBC, Hernández-DíazS, et al. Specifying a target trial prevents immortal time bias and other self-inflicted injuries in observational analyses[J]. J Clin Epidemiol, 2016, 79: 70-75. DOI: 10.1016/j.jclinepi.2016.04.014.

6. ZuoH, YuL, CampbellSM, et al. The implementation of target trial emulation for causal inference: a scoping review[J]. J Clin Epidemiol, 2023, 162: 29-37. DOI: 10.1016/j.jclinepi.2023.08.003.

7. 龙子临, 赵厚宇, 刘佐相, 等. 目标试验仿真的全球进展与趋势:文献计量分析与可视化[J]. 中华流行病学杂志, 2025, 46(7): 1262-1268.LongZL, ZhaoHY, LiuZX, et al. Global progress and trend in research of target trial emulation: a bibliometric and visualization analysis[J]. Chinese Journal of Epidemiology, 2025, 46(7): 1262-1268. DOI: 10.3760/cma.j.cn112338-20241105-00694.

8. European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence for regulatory purposes[R]. Amsterdam: European Medicines Agency, 2024.

9. NICE. NICE real-world evidence framework[R]. London: NICE, 2022.

10. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Guide on methodological standards in pharmacoepidemiology (Revision 11)[R]. Amsterdam: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), 2023.

11. HernánMA, WangW, LeafDE. Target trial emulation: a framework for causal inference from observational data[J]. JAMA, 2022, 328(24): 2446-2447. DOI: 10.1001/jama.2022.21383.

12. MatthewsAA, DanaeiG, IslamN, et al. Target trial emulation: applying principles of randomised trials to observational studies[J]. BMJ, 2022, 378: e071108. DOI: 10.1136/bmj-2022-071108.

13. HubbardRA, GatsonisCA, HoganJW, et al. "Target trial emulation" for observational studies — potential and pitfalls[J]. N Engl J Med, 2024, 391(21): 1975-1977. DOI: 10.1056/NEJMp2407586.

14. VandenbrouckeJP, von ElmE, AltmanDG, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration[J]. Ann Intern Med, 2007, 147(8): W163-W194. DOI: 10.7326/0003-4819-147-8-200710160-00010-w1.

15. BenchimolEI, SmeethL, GuttmannA, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement[J]. PLoS Med, 2015, 12(10): e1001885. DOI: 10.1371/journal.pmed.1001885.

16. CashinAG, HansfordHJ, HernánMA, et al. Transparent Reporting of Observational Studies Emulating a Target Trial: the TARGET statement[J]. BMJ, 2025, 390: e087179. DOI: 10.1136/bmj-2025-087179.

17. CashinAG, HansfordHJ, HernánMA, et al. Transparent Reporting of Observational Studies Emulating a Target Trial—the TARGET statement[J]. JAMA, 2025, 334(12): 1084-1093. DOI: 10.1001/jama.2025.13350.

18. HernánMA, SterneJAC, HigginsJPT, et al. A structural description of biases that generate immortal time[J]. Epidemiology, 2025, 36(1): 107-114. DOI: 10.1097/EDE.0000000000001808.

19. HernánMA, DahabrehIJ, DickermanBA, et al. The target trial framework for causal inference from observational data: why and when is it helpful?[J]. Ann Intern Med, 2025, 178(3): 402-407. DOI: 10.7326/ANNALS-24-01871.

20. 卢存存, 陈子佳, 张强, 等. 基于真实世界数据的目标试验模拟研究: 现状与展望[J]. 中国循证医学杂志, 2023, 23(4): 492-496.LuCC, ChenZJ, ZhangQ, et al. Target trial emulation study based on real world data: status quo and prospect[J]. Chinese Journal of Evidence-Based Medicine, 2023, 23(4): 492-496. DOI: 10.7507/1672-2531.202209032.

21. 袁驰, 周祎灵, 曹雨滋, 等. 基于真实世界数据的观察性研究因果推断——目标试验模拟实施要点及案例分析[J]. 中国胸心血管外科临床杂志, 2024, 31(12): 1743-1752.YuanC, ZhouYL, CaoYZ, et al. Causal inference in observational studies based on real-world data: key points and case studies for target trial emulation[J]. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(12): 1743-1752. DOI: 10.7507/1007-4848.202407072.

22. 周佳薇, 黄丽红, 尤东方, 等. 利用现实世界数据仿真临床试验:目标试验的发展与应用[J]. 中华流行病学杂志, 2024, 45(2): 279-285.ZhouJW, HuangLH, YouDF, et al. The emulation of clinical trials with real-world data: development and application of target trial[J]. Chinese Journal of Epidemiology, 2024, 45(2): 279-285. DOI: 10.3760/cma.j.cn112338-20230821-00081.

23. 卓琳, 曾琳, 赵一鸣. 模拟目标试验概念及其关键要素[J]. 中华儿科杂志, 2024, 62(8): 751.ZhuoL, ZengL, ZhaoYM. The concept of target trial emulation and its key elements[J]. Chinese Journal of Pediatrics, 2024, 62(8): 751. DOI: 10.3760/cma.j.cn112140-20240523-00358.

24. 陶立元, 刘珏. 目标仿真试验的基本原理、设计要素及其优缺点[J]. 中华流行病学杂志, 2023, 44(12): 1963-1969.TaoLY, LiuJ. Basic principles, design elements, advantages and challenges of emulated target trial[J]. Chinese Journal of Epidemiology, 2023, 44(12): 1963-1969. DOI: 10.3760/cma.j.cn112338-20230515-00300.

25. MoherD, SchulzKF, SimeraI, et al. Guidance for developers of health research reporting guidelines[J]. PLoS Med, 2010, 7(2): e1000217. DOI: 10.1371/journal.pmed.1000217.

26. HansfordHJ, CashinAG, JonesMD, et al. Development of the TrAnsparent ReportinG of observational studies Emulating a Target trial (TARGET) guideline[J]. BMJ Open, 2023, 13(9): e074626. DOI: 10.1136/bmjopen-2023-074626.

27. HansfordHJ, CashinAG, JonesMD, et al. Reporting of observational studies explicitly aiming to emulate randomized trials[J]. JAMA Netw Open, 2023, 6(9): e2336023. DOI: 10.1001/jamanetworkopen.2023.36023.

28. LashTL, RothmanKJ. Modern epidemiology, 3rd ed [M]. Philadelphia: Lippincott Williams & Wilkins, 2021: 53-77.

29. SuissaS, Dell'AnielloS. Time-related biases in pharmacoe-pidemiology[J]. Pharmacoepidemiol Drug Saf, 2020, 29(9): 1101-1110. DOI: 10.1002/pds.5083.

30. HernánMA, RobinsJM. Causal inference: what if[M]. Boca Raton: CRC Press, 2020.

31. TurchinA, PetitoLC, HegermillerE, et al. Cardiovascular events in individuals treated with sulfonylureas or dipeptidyl peptidase 4 inhibitors[J]. JAMA Netw Open, 2025, 8(7): e2523067. DOI: 10.1001/jamanetworkopen.2025.23067.

32. RichardsonWS, WilsonMC, NishikawaJ, et al. The well-built clinical question: a key to evidence-based decisions[J]. ACP J Club, 1995, 123(3): A12-A13. https://pubmed.ncbi.nlm.nih.gov/7582737/

33. DahabrehIJ, RobertsonSE, HernánMA. Generalizing and transporting inferences about the effects of treatment assignment subject to non-adherence[EB/OL]. (2022-11-09) [2025-12-18]. http://arxiv.org/abs/2211.04876.

34. CainLE, RobinsJM, LanoyE, et al. When to start treatment? A systematic approach to the comparison of dynamic regimes using observational data[J]. Int J Biostat, 2010, 6(2): 18. DOI: 10.2202/1557-4679.1212.

35. YoungJG, StensrudMJ, Tchetgen TchetgenEJ, et al. A causal framework for classical statistical estimands in failure-time settings with competing events[J]. Stat Med, 2020, 39(8): 1199-1236. DOI: 10.1002/sim.8471.

36. KahanBC, HindleyJ, EdwardsM, et al. The estimands framework: a primer on the ICH E9(R1) addendum[J]. BMJ, 2024, 384: e076316. DOI: 10.1136/bmj-2023-076316.

37. HernánMA, RobinsJM. Per-protocol analyses of pragmatic trials[J]. N Engl J Med, 2017, 377(14): 1391-1398. DOI: 10.1056/NEJMsm1605385.

38. DanaeiG, RodríguezLA, CanteroOF, et al. Observational data for comparative effectiveness research: an emulation of randomised trials of statins and primary prevention of coronary heart disease.[J]. Stat Methods Med Res, 2013, 22(1): 70-96. DOI: 10.1177/0962280211403603.

39. HernánMA. How to estimate the effect of treatment duration on survival outcomes using observational data[J]. BMJ, 2018, 360: k182. DOI: 10.1136/bmj.k182.

40. LipsitchM, Tchetgen TchetgenE, CohenT. Negative controls: a tool for detecting confounding and bias in observational studies[J]. Epidemiology, 2010, 21(3): 383-388. DOI: 10.1097/EDE.0b013e3181d61eeb.

41. LashTL, FoxMP, MacLehoseRF, et al. Good practices for quantitative bias analysis[J]. Int J Epidemiol, 2014, 43(6): 1969-1985. DOI: 10.1093/ije/dyu149.

42. HopewellS, ChanAW, CollinsGS, et al. CONSORT 2025 statement[J]. JAMA, 2025, 333(22): 1998-2005. DOI: 10.1001/jama.2025.4347.

43. SterneJA, HernánMA, ReevesBC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions[J]. BMJ, 2016, 355: i4919. DOI: 10.1136/bmj.i4919.

44. SharpMK, GlontiK, HrenD. Online survey about the STROBE statement highlighted diverging views about its content, purpose, and value[J]. J Clin Epidemiol, 2020, 123: 100-106. DOI: 10.1016/j.jclinepi.2020.03.025.

45. DickermanBA, García-AlbénizX, LoganRW, et al. Emulating a target trial in case-control designs: an application to statins and colorectal cancer[J]. Int J Epidemiol , 2020, 49(5): 1637-1646. DOI: 10.1093/ije/dyaa144.

46. SeewaldNJ, McGintyEE, StuartEA. Target trial emulation for evaluating health policy[J]. Ann Intern Med, 2024, 177(11): 1530-1538. DOI: 10.7326/M23-2440.

47. SwansonSA. Instrumental variable analyses in pharmacoepide miology: what target trials do we emulate?[J]. Curr Epidemiol Rep, 2017, 4(4): 281-287. DOI: 10.1007/s40471-017-0120-1.

48. 中国康复医学会康复大数据工作委员会. 目标仿真试验临床研究应用规范专家共识(2025版)[J]. 中华医学杂志, 2025, 105(46): 4239-4250.Expert Group for the Development of the Expert Consensus on the Standardized Application of Emulated Target Trials. Expert consensus on the standardized application of emulated target trials in clinical research (2025 edition)[J]. National Medical Journal of China, 2025, 105(46): 4239-4250. DOI: 10.3760/cma.j.cn112137-20250722-01821.

Popular papers
Last 6 months