Structured template and reporting tool for real world evidence (STaRT-RWE) was developed by a team led by professor Shirley V Wang of Brigham and Women's Hospital, Harvard Medical School, which is to plan and report on the implementation of real world evidence (RWE) studies on the safety and efficacy of treatments. The template, published in the journal BMJ in January 2021, has been endorsed by the International Society of PharmacoEpidemiology and the Transparency Initiative promoted by the International Society of Pharmacoeconomics and Outcome Research. This article interprets its entries to promote the understanding and application of STaRT-RWE by domestic scholars engaged in real world study, and help to improve the transparency, repeatability, and accuracy of RWE research.
Citation：
CAO Xue, MENG Xiangran, WANG Xin, QIN Yuning, WANG Mengqi, LIU Jia. Structured template for planning and reporting on the implementation of real world evidence studies (STaRT-RWE): an interpretation. Chinese Journal of Evidence-Based Medicine, 2024, 24(8): 967-973. doi: 10.7507/1672-2531.202312132
Copy
| 1. |
|
| 2. |
|
| 3. |
|
| 4. |
|
| 5. |
|
| 6. |
|
| 7. |
|
| 8. |
|
| 9. |
|
| 10. |
Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018, 363: k3532.
|
| 11. |
European Medicines Agency. ENCePP checklist for study protocols (revision 4). 2018.
|
| 12. |
|
| 13. |
|
| 14. |
US Food and Drug Administration. Guidance for industry and FDA staff: best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data. 2013.
|
| 15. |
|
| 16. |
|
| 17. |
|
| 18. |
|
| 19. |
European Medicines Agency. Guidance for theformat and content of the protocol of non-interventional post-authorisation safety studies (2012). 2021.
|
| 20. |
|
| 21. |
NEST Coordinating Center. National evaluation system for health technology coordinating center(NESTcc) dataquality framework (2020). 2020.
|
| 22. |
|
| 23. |
|
| 24. |
|
| 25. |
|
| 26. |
|
- 1.
- 2.
- 3.
- 4.
- 5.
- 6.
- 7.
- 8.
- 9.
- 10. Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ, 2018, 363: k3532.
- 11. European Medicines Agency. ENCePP checklist for study protocols (revision 4). 2018.
- 12.
- 13.
- 14. US Food and Drug Administration. Guidance for industry and FDA staff: best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data. 2013.
- 15.
- 16.
- 17.
- 18.
- 19. European Medicines Agency. Guidance for theformat and content of the protocol of non-interventional post-authorisation safety studies (2012). 2021.
- 20.
- 21. NEST Coordinating Center. National evaluation system for health technology coordinating center(NESTcc) dataquality framework (2020). 2020.
- 22.
- 23.
- 24.
- 25.
- 26.
