從墨西哥到馬里：臨床試驗注冊發展歷程四年回顧_《中國循證醫學雜志》

作者：

Davina Ghersi , Tikki Pang

1. 世界衛生組織科研制度與合作部國際臨床試驗注冊平臺（瑞士）；2. 世界衛生組織研究政策與合作司（瑞士）;

關鍵詞：

DOI：

10.7507/1672-2531.20090023

視頻：

導出 下載 收藏 掃碼 引用

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

引用本文： . 從墨西哥到馬里：臨床試驗注冊發展歷程四年回顧. 中國循證醫學雜志, 2009, 09(2): 123-126. doi: 10.7507/1672-2531.20090023 復制

1.	International Committee of Medical Journal Editors (ICMJE). Clinical Trial Registration: A statement from the International Committee of Medical Journal Editors. Available from http://www. icmje.org/clin_trial.pdf (Accessed 14th November 2008).
2.	The Mexico Statement on Health Research. Knowledge for better health: strengthening health systems. November 16–20, 2004. Available from http://www.who.int/rpc/summit/agenda/en/mexico_statement_on_health_research.pdf (accessed Nov 14, 2008).
3.	Sterne JAC, Egger M, Moher D. Chapter 10: Addressing reporting biases. In Cochrane Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org.
4.	Tonkin A, Jureidini J. Wishful thinking: antidepressant drugs in childhood depression. Br J Psychiatry, 2005, 10(187): 304-305.
5.	Wessely S, Kerwin R. Suicide risk and the SSRIs. JAMA, 2004, 292(3): 379-381.
6.	Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet, 2004, 364(9450): 1995-1996.
7.	Juni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet, 2004, 364(9450): 2021-2029.
8.	Simes RJ. The case for an international registry of clinical trials. J Clin Oncol, 1986, 4(10): 1529-1541.
9.	Dickersin K. Report from the panel on the Case for Registers of Clinical Trials at the Eighth Annual Meeting of the Society for Clinical Trials. Control Clin Trials, 1988, 9(1): 76-81.
10.	Food and Drug Administration. Food and Drug Administration Modernization Act. Available from http://www.fda.gov/oashi/ clinicaltrials/section113/.
11.	International Standardised Randomised Controlled Trial Number (ISRCTN). Available from http://www.controlled-trials.com/ isrctn/). Accessed 9th January 2009.
12.	Sim I, Chan A, Gulmezoglu AM, et al. Clinical Trial Registration: transparency is the watchword. Lancet, 2006, 367 (9523): 1631-1633.
13.	International Committee of Medical Journal Editors (ICMJE). Clinical Trial Registration: Looking Back and Moving Ahead. Available from http://www.icmje.org/clin_trial07.pdf (Accessed 14th November 2008).
14.	Ghersi D, Pang T. En route to international clinical trial transparency. Lancet, 2008, 372(9649): 1531-1532.
15.	Clarke M. Personal communication. 9th January 2009.
16.	Jia H. China beckons to clinical trial sponsors . Nature Biotechnology. Available from http://www.nature.com/drugdisc/news/articles/nbt0705-768.html (Accessed 9th January 2009).
17.	The Bamako Call to Action on Research for Health. November 2008. Available from http://www.tropika.net/svc/specials/bamako2008/ call-for-action/call. (Accessed 9th January 2009).
18.	Food and Drug Administration. Food and Drug Administration Amendments Acto of 2007. Available from http://www.fda.gov/oc/ initiatives/hr3580.pdf (Accessed 9th January 2009).
19.	Agencia Nacional de Vigilancia Sanitaria. Resolucao RDC no 39, de 05 de junho de 2008. June 5, 2008. Available from http://e-legis. anvisa.gov.br/leisref/public/showAct.php?id=31279 (accessed October 14, 2008) (in Portuguese).
20.	World Medical Association. Declaration of Helsinki. Available from http://www.wma.net/e/policy/b3.htm. (accessed November 13, 2008).
21.	Savalescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ, 1996, 313(7069): 1390-1393.
22.	Mann H. Research ethics committees and public dissemination of clinical trial results. Lancet, 2002, 360(9330): 406-408.
23.	Tharyan P. Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions. Indian J Med Ethics, 2007, 4(4): 168-169.
24.	Satyanarayana K, Sharma A, Parikh P, et al. Statement on publishing clinical trials in Indian biomedical journals. Natl Med J India, 2008, 21(3): 105-106.
25.	李幼平, 吳泰相, 李靜, 等. 創建中國臨床試驗注冊和發表機制的聯合宣言, 2006, 6(6): 393-394.
26.	Cameron E. Available from http://data.unaids.org/pub/Speech/2006/P_ECameron%20Microbicides%20Apri%20l2006_en.pdf (accessed October 14 2008).
27.	Editorial. Establishing transparency to restore trust in clinical trials. Lancet Neurol, 2006, 5(8): 551.
28.	Abbasi K, Godlee F. Next steps in trial registration. BMJ, 2005, 330(7502): 1222-1223.
29.	Crace C. Peer trouble. The Guardian. February 11 2003.

1. International Committee of Medical Journal Editors (ICMJE). Clinical Trial Registration: A statement from the International Committee of Medical Journal Editors. Available from http://www. icmje.org/clin_trial.pdf (Accessed 14th November 2008).
2. The Mexico Statement on Health Research. Knowledge for better health: strengthening health systems. November 16–20, 2004. Available from http://www.who.int/rpc/summit/agenda/en/mexico_statement_on_health_research.pdf (accessed Nov 14, 2008).
3. Sterne JAC, Egger M, Moher D. Chapter 10: Addressing reporting biases. In Cochrane Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane-handbook.org.
4. Tonkin A, Jureidini J. Wishful thinking: antidepressant drugs in childhood depression. Br J Psychiatry, 2005, 10(187): 304-305.
5. Wessely S, Kerwin R. Suicide risk and the SSRIs. JAMA, 2004, 292(3): 379-381.
6. Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet, 2004, 364(9450): 1995-1996.
7. Juni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet, 2004, 364(9450): 2021-2029.
8. Simes RJ. The case for an international registry of clinical trials. J Clin Oncol, 1986, 4(10): 1529-1541.
9. Dickersin K. Report from the panel on the Case for Registers of Clinical Trials at the Eighth Annual Meeting of the Society for Clinical Trials. Control Clin Trials, 1988, 9(1): 76-81.
10. Food and Drug Administration. Food and Drug Administration Modernization Act. Available from http://www.fda.gov/oashi/ clinicaltrials/section113/.
11. International Standardised Randomised Controlled Trial Number (ISRCTN). Available from http://www.controlled-trials.com/ isrctn/). Accessed 9th January 2009.
12. Sim I, Chan A, Gulmezoglu AM, et al. Clinical Trial Registration: transparency is the watchword. Lancet, 2006, 367 (9523): 1631-1633.
13. International Committee of Medical Journal Editors (ICMJE). Clinical Trial Registration: Looking Back and Moving Ahead. Available from http://www.icmje.org/clin_trial07.pdf (Accessed 14th November 2008).
14. Ghersi D, Pang T. En route to international clinical trial transparency. Lancet, 2008, 372(9649): 1531-1532.
15. Clarke M. Personal communication. 9th January 2009.
16. Jia H. China beckons to clinical trial sponsors . Nature Biotechnology. Available from http://www.nature.com/drugdisc/news/articles/nbt0705-768.html (Accessed 9th January 2009).
17. The Bamako Call to Action on Research for Health. November 2008. Available from http://www.tropika.net/svc/specials/bamako2008/ call-for-action/call. (Accessed 9th January 2009).
18. Food and Drug Administration. Food and Drug Administration Amendments Acto of 2007. Available from http://www.fda.gov/oc/ initiatives/hr3580.pdf (Accessed 9th January 2009).
19. Agencia Nacional de Vigilancia Sanitaria. Resolucao RDC no 39, de 05 de junho de 2008. June 5, 2008. Available from http://e-legis. anvisa.gov.br/leisref/public/showAct.php?id=31279 (accessed October 14, 2008) (in Portuguese).
20. World Medical Association. Declaration of Helsinki. Available from http://www.wma.net/e/policy/b3.htm. (accessed November 13, 2008).
21. Savalescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ, 1996, 313(7069): 1390-1393.
22. Mann H. Research ethics committees and public dissemination of clinical trial results. Lancet, 2002, 360(9330): 406-408.
23. Tharyan P. Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions. Indian J Med Ethics, 2007, 4(4): 168-169.
24. Satyanarayana K, Sharma A, Parikh P, et al. Statement on publishing clinical trials in Indian biomedical journals. Natl Med J India, 2008, 21(3): 105-106.
25. 李幼平, 吳泰相, 李靜, 等. 創建中國臨床試驗注冊和發表機制的聯合宣言, 2006, 6(6): 393-394.
26. Cameron E. Available from http://data.unaids.org/pub/Speech/2006/P_ECameron%20Microbicides%20Apri%20l2006_en.pdf (accessed October 14 2008).
27. Editorial. Establishing transparency to restore trust in clinical trials. Lancet Neurol, 2006, 5(8): 551.
28. Abbasi K, Godlee F. Next steps in trial registration. BMJ, 2005, 330(7502): 1222-1223.
29. Crace C. Peer trouble. The Guardian. February 11 2003.

《中國循證醫學雜志》

從墨西哥到馬里：臨床試驗注冊發展歷程四年回顧

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

上一篇

下一篇

Format

Content

《中國循證醫學雜志》

從墨西哥到馬里：臨床試驗注冊發展歷程四年回顧

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

上一篇

下一篇

Format

Content

摘要全文圖表視頻參考文獻施引文獻補充材料