Declaration of Helsinki
description
Transcript of Declaration of Helsinki
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Declaration of Helsinki
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CONSORT Statement
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GPP-2
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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
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Introduction: Why?
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Why? In whom?
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Are we going in right direction?
0%
5%
10%
15%
20%
25%
Clinical trials
Disease burden DALYs/1000 capita/year
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Introduction: Why?
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CONSORT Statement
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Lau J et al Cumulative meta-analysis of therapeutic trials for myocardial infarction
NEJM 327:248-254
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Methods: Protocol
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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
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Methods - CONSORT
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Methods: Intervention
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? Standard of care and access to
healthcare?
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“Country profiles of Environmental Burden of Disease” by WHO (2009)
http://www.who.int/quantifying_ehimpacts/national/countryprofile/india.pdf
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Access to medicines?
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Trials registered in ctri (accessed 2nd December 2009) and disease burden estimates
0100200300400500600700800
Cancer Diabetes HIV TB Malaria Asthma Diarrhea
No. of trials No. of cases (lacs)
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Intervention: Standard of care?
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Methods: Intervention
212 of the trials at ctri
are placebo
controlled
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Methods: Intervention (CONSORT)
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Methods
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Trials registered at clinicaltrials.govaccessed 2nd December 2009
Total: 82,180 trials in 170 countries
USA: 45116 (55%)
1.4%1.4%
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Investigator Initiated trials (USA)
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U.S. Public Law 110-85 (FDAAA)
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www.ctri.inaccessed 2nd December 2009
India 626
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India launched Clinical Trials Registry20 Jul 2007
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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
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Methods
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ICMR Guidelines, 2006 IX. Researcher’s relations with the
media and publication
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ICMR Guidelines, 2006 IX. Researcher’s relations with the
media and publication
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Informed ConsentPara 24
Independent ReviewPara 15
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Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci 2008;62:134-40
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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
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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
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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
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Methods
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Communicating results...
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“The file-drawer problem” (Rosenthal, 1979)
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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
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Turner et al, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, NEJM, 2008; 358:252-260
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Turner et al, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, NEJM, 2008; 358:252-260
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Results and further
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Declaration of Helsinki, 2008
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