The WHO International Clinical Trials Registry Platform: Relevance to the Indian register of clinical trials

National Medical Journal of India

Volumn 19, Issue 3, 2006, Pages 161-164

  Tharyan, Prathap ^a  

^a CHRISTIAN MEDICAL COLLEGE   (India)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ACCESS TO INFORMATION; ARTICLE; CLINICAL PROTOCOL; CLINICAL STUDY; CLINICAL TRIAL; CONSULTATION; DRUG INDUSTRY; HEALTH CARE POLICY; HUMAN; INDIA; INFORMATION PROCESSING; INTERNAL VALIDITY; INTERNET; INTERPERSONAL COMMUNICATION; MANDATORY REPORTING; MEDICAL ETHICS; MEDICAL LITERATURE; MEDICAL RESEARCH; META ANALYSIS; PRACTICE GUIDELINE; PUBLICATION; PUBLISHING; REGISTER; REGISTRATION; SYSTEMATIC REVIEW; WORLD HEALTH ORGANIZATION;

CLINICAL TRIALS; CLINICAL TRIALS DATA MONITORING COMMITTEES; COOPERATIVE BEHAVIOR; DISCLOSURE; HUMANS; INDIA; INTERNATIONAL COOPERATION; PUBLISHING; REGISTRIES; WORLD HEALTH ORGANIZATION;

EID: 33745454306     PISSN: 0970258X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Bhatt A, Sewlikar S. Registering clinical trials in India. Natl Med J India 2006; 19:1-3.
2. World Health Organization. Department of Research Policy and Cooperation (RPC). http://www.who.int/rpc/en/index.html (accessed 23 March 2006)
3. World Health Organization. International Clinical Trials Registry Platform (ICTRP). http://www.who.int/ictrp/en (accessed 23 March 2006).
4. World Health Organization. International Clinical Trials Registry Platform (ICTRP): International Advisory Board. http://www.who.int/ictrp/about/details/en/index2.htm (accessed 23 March 2006).
5. World Health Organization. International Clinical Trials Registry Platform (ICTRP): Scientific Advisory Board. http://www.who.int/ictrp/about/details/en/index3.htm (accessed 23 March 2006).
6. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. International Committee of Medical Journal Editors. Clinical trial registration: A statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351:1250-1.
7. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials: The CONSORT statement. JAMA 1996;276:637-9.
8. Moher D, Schulz KF, Altman D. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987-91.
9. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet 2005;365:1159-62.
10. Pfizer response to World Health Organzation consultation on International Clinical Registry Platform (ICTRP). Invitation for open comments, January 2006. http://www.who.int/entity/ictrp/3006_Pfizer_25Jan06.pdf (accessed 23 March 2006).
11. Roche comments on delayed disclosure. International Clinical Trials Registry Platform(ICTRP). January 2006. http://www.who.int/entity/ictrp/3004_Hoffmann-La%20Roche_25Jan06.pdf (accessed 23 March 2006).
12. European Cancer Patient Coalition. Open comments of cancer patients to WHO on delayed public disclosure of clinical trials information. January 2006. http://www.who. int/entity/ictrp/3003_ECPC_25Jan06.pdf (accessed 23 March 2006).
13. Goodyear M. Learning from the TGN1412 trial. BMJ 2006;332:677-8.
14. Abbott response to World Health Organization International Clinical Trials Registry Platform (ICTRP) request for open comments on disclosure timing. 24 January 2006 http://www.who.int/entity/ictrp/3001_Abbott_?USA_25Jan06.pdf (accessed 23 March 2006).
15. Zarin DA, Tse T, Ide NC. Trial Registration at Clinical Trials.gov between May and October 2005. N Engl J Med 2005;353:2779-87.
16. Drazen JM, Wood AJ. Trial registration report card. N Engl J Med 2005;353: 2809-11.
17. Mudur G. Indian study sparks debate on the use of placebo in psychiatry trials. BMJ 2006;332:566.
18. Tharyan P. Placebo-controlled trials in psychiatry on trial. Indian J Med Ethics 2006;3:13-16.
19. World Health Organization. International Clinical Trials Registry Platform (ICTRP): Results reporting. http://www.who.int/ictrp/results/en (accessed 23 March 2006).
20. ICH International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use. ICH harmonized tripartite guideline: Structure and content of clinical study reports. http://www.who.int/ictrp/results/E3synopsis.pdf (accessed 23 March 2006)
21. ASSERT: A Standard for the Scientific and Ethical Review of Trial. www.assert-statement.org (accessed 24 March 2006)
22. The Cochrane Central Register of Controlled Trials (CCTR): The Evidence Based Medicine Reviews Collection. The Cochrane Library. www.thecochranelibrary.com (accessed 24 March 2006).
23. Sim I, Chan AW, Gulmezoglu AM, Evans T, Pang T. Clinical trial registration: Transparency is the watchword. Lancet 2006;367:1631-3.
24. Godlee F. An international standard for disclosure of clinical trial information. BMJ 2006;332:1107-8.
25. Horton R. Trial registers: Protecting patients, advancing trust. Lancet 2006; 367:1633-5.