From Mexico to Mali: Four Years in the History of Clinical Trial Registration_Chinese Journal of Evidence-Based Medicine

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Davina Ghersi , Tikki Pang

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10.7507/1672-2531.20090023

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Citation： Davina Ghersi,Tikki Pang. From Mexico to Mali: Four Years in the History of Clinical Trial Registration. Chinese Journal of Evidence-Based Medicine, 2009, 09(2): 123-126. doi: 10.7507/1672-2531.20090023 Copy

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, 吴泰相, 李静, 等. 创建中国临床试验注册和发表机制的联合宣言, 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, 吴泰相, 李静, 等. 创建中国临床试验注册和发表机制的联合宣言, 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.

Chinese Journal of Evidence-Based Medicine

From Mexico to Mali: Four Years in the History of Clinical Trial Registration

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