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Declaration of Helsinki. CONSORT Statement. GPP-2. 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
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Declaration of Helsinki Writecon, 2009, KEMH
CONSORT Statement Writecon, 2009, KEMH
GPP-2 Writecon, 2009, KEMH
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
Introduction: Why? Writecon, 2009, KEMH
Why? In whom? Writecon, 2009, KEMH
Are we going in right direction? Writecon, 2009, KEMH
Introduction: Why? Writecon, 2009, KEMH
CONSORT Statement Writecon, 2009, KEMH
Lau J et alCumulative meta-analysis of therapeutic trials for myocardial infarctionNEJM 327:248-254 Writecon, 2009, KEMH
Methods: Protocol Writecon, 2009, KEMH
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
Methods - CONSORT Writecon, 2009, KEMH
Methods: Intervention ? Standard of care and access to healthcare? Writecon, 2009, KEMH
“Country profiles of Environmental Burden of Disease” by WHO (2009)http://www.who.int/quantifying_ehimpacts/national/countryprofile/india.pdf Writecon, 2009, KEMH
Access to medicines? Writecon, 2009, KEMH
Trials registered in ctri (accessed 2nd December 2009) and disease burden estimates Writecon, 2009, KEMH
Intervention: Standard of care? Writecon, 2009, KEMH
212 of the trials at ctri are placebo controlled Methods: Intervention Writecon, 2009, KEMH
Methods: Intervention (CONSORT) Writecon, 2009, KEMH
Methods Writecon, 2009, KEMH
Trials registered at clinicaltrials.govaccessed 2nd December 2009 Total: 82,180 trials in 170 countries USA: 45116 (55%) 1.4% Writecon, 2009, KEMH
Investigator Initiated trials (USA) Writecon, 2009, KEMH
U.S. Public Law 110-85 (FDAAA) Writecon, 2009, KEMH
www.ctri.inaccessed 2nd December 2009 India 626 Writecon, 2009, KEMH
India launched Clinical Trials Registry20 Jul 2007 Writecon, 2009, KEMH
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
Methods Writecon, 2009, KEMH
ICMR Guidelines, 2006 IX. Researcher’s relations with the media and publication Writecon, 2009, KEMH
ICMR Guidelines, 2006 IX. Researcher’s relations with the media and publication Writecon, 2009, KEMH
Twin pillars of human protection • Independent Review • Para 15 Informed Consent Para 24 Writecon, 2009, KEMH
Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci 2008;62:134-40 Writecon, 2009, KEMH
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
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
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
Methods Writecon, 2009, KEMH
Communicating results... Writecon, 2009, KEMH
“The file-drawer problem” (Rosenthal, 1979) Writecon, 2009, KEMH
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
Turner et al, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, NEJM, 2008; 358:252-260 Writecon, 2009, KEMH
Turner et al, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, NEJM, 2008; 358:252-260 Writecon, 2009, KEMH
Results and further Writecon, 2009, KEMH
Declaration of Helsinki, 2008 Writecon, 2009, KEMH