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Declaration of Helsinki

Declaration of Helsinki

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Declaration of Helsinki

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  1. Declaration of Helsinki Writecon, 2009, KEMH

  2. CONSORT Statement Writecon, 2009, KEMH

  3. Writecon, 2009, KEMH

  4. GPP-2 Writecon, 2009, KEMH

  5. New or updated codes of good practices in publications since 2003 • International Society for Medical Publication Professionals (www.ismpp.org): the role of the professional medical writer • American Medical Writers Association (www.amwa.org): the contribution of medical writers to scientific publications • Committee on Publication Ethics (http://publicationethics.org) • Council of Science Editors (www.councilscienceeditors.org) white paper on promoting integrity in scientific journal publications • European Medical Writers Association (www.emwa.org ) Guidelines on the role of medical writers in developing peer reviewed publications • EQUATOR Network (www.equator-network.org ) Reporting guidelines—for example, CONSORT, STROBE, QUOROM/PRISMA, STARD, MOOSE • International Committee of Medical Journal Editors (www.icmje.org) Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication Writecon, 2009, KEMH

  6. Introduction: Why? Writecon, 2009, KEMH

  7. Why? In whom? Writecon, 2009, KEMH

  8. Are we going in right direction? Writecon, 2009, KEMH

  9. Introduction: Why? Writecon, 2009, KEMH

  10. CONSORT Statement Writecon, 2009, KEMH

  11. Lau J et alCumulative meta-analysis of therapeutic trials for myocardial infarctionNEJM 327:248-254 Writecon, 2009, KEMH

  12. Methods: Protocol Writecon, 2009, KEMH

  13. Tharyan et al, Editorial policy and the reporting of randomized controlled trials: A survey of instructions for authors and assessment of trial reports in Indian medical journals (2004–05), NMJI, 2008;21:62–8 Writecon, 2009, KEMH

  14. Methods - CONSORT Writecon, 2009, KEMH

  15. Methods: Intervention ? Standard of care and access to healthcare? Writecon, 2009, KEMH

  16. “Country profiles of Environmental Burden of Disease” by WHO (2009)http://www.who.int/quantifying_ehimpacts/national/countryprofile/india.pdf Writecon, 2009, KEMH

  17. Access to medicines? Writecon, 2009, KEMH

  18. Trials registered in ctri (accessed 2nd December 2009) and disease burden estimates Writecon, 2009, KEMH

  19. Intervention: Standard of care? Writecon, 2009, KEMH

  20. 212 of the trials at ctri are placebo controlled Methods: Intervention Writecon, 2009, KEMH

  21. Methods: Intervention (CONSORT) Writecon, 2009, KEMH

  22. Methods Writecon, 2009, KEMH

  23. Trials registered at clinicaltrials.govaccessed 2nd December 2009 Total: 82,180 trials in 170 countries USA: 45116 (55%) 1.4% Writecon, 2009, KEMH

  24. Investigator Initiated trials (USA) Writecon, 2009, KEMH

  25. U.S. Public Law 110-85 (FDAAA) Writecon, 2009, KEMH

  26. www.ctri.inaccessed 2nd December 2009 India 626 Writecon, 2009, KEMH

  27. India launched Clinical Trials Registry20 Jul 2007 Writecon, 2009, KEMH

  28. India launched Clinical Trials Registry20 Jul 2007 F.No. 12-01/09-DC-(Pt-32) Registration of Clinical trials mandatory w.e.f 15th June 2006 Writecon, 2009, KEMH

  29. Methods Writecon, 2009, KEMH

  30. ICMR Guidelines, 2006 IX. Researcher’s relations with the media and publication Writecon, 2009, KEMH

  31. ICMR Guidelines, 2006 IX. Researcher’s relations with the media and publication Writecon, 2009, KEMH

  32. Twin pillars of human protection • Independent Review • Para 15 Informed Consent Para 24 Writecon, 2009, KEMH

  33. Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci 2008;62:134-40 Writecon, 2009, KEMH

  34. Tharyanet al, Editorial policy and the reporting of randomized controlled trials: A survey of instructions for authors and assessment of trial reports in Indian medical journals (2004–05), NMJI, 2008;21:62–8 Writecon, 2009, KEMH

  35. Tharyanet al, Editorial policy and the reporting of randomized controlled trials: A survey of instructions for authors and assessment of trial reports in Indian medical journals (2004–05), NMJI, 2008;21:62–8 Writecon, 2009, KEMH

  36. Bavdekar SB, Gogtay NJ, Chavan R. Reporting ethical processes: Survey of 'instructions to authors' provided by Indian journals. Indian J Med Sci 2009;63:260-2 Writecon, 2009, KEMH

  37. Methods Writecon, 2009, KEMH

  38. Communicating results... Writecon, 2009, KEMH

  39. “The file-drawer problem” (Rosenthal, 1979) Writecon, 2009, KEMH

  40. Extent of publication bias in different categories of research cohorts: a meta-analysis of empirical studiesBMC Medical Research Methodology 2009, 9:79 doi:10.1186/1471-2288-9-79 Writecon, 2009, KEMH

  41. Turner et al, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, NEJM, 2008; 358:252-260 Writecon, 2009, KEMH

  42. Turner et al, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, NEJM, 2008; 358:252-260 Writecon, 2009, KEMH

  43. Results and further Writecon, 2009, KEMH

  44. Declaration of Helsinki, 2008 Writecon, 2009, KEMH