declaration of helsinki

Declaration of Helsinki

Friday, April 21, 2023 1Writecon, 2009, KEMH

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

• 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


Introduction: Why?


Why? In whom?

Friday, April 21, 20238

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Are we going in right direction?

0%

5%

10%

15%

20%

25%

Clinical trials

Disease burden DALYs/1000 capita/year


Introduction: Why?


CONSORT Statement


Lau J et al Cumulative meta-analysis of therapeutic trials for myocardial infarction

NEJM 327:248-254


Methods: Protocol


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


Methods - CONSORT


Methods: Intervention


? Standard of care and access to

healthcare?

“Country profiles of Environmental Burden of Disease” by WHO (2009)

http://www.who.int/quantifying_ehimpacts/national/countryprofile/india.pdf


Access to medicines?

Friday, April 21, 2023 Writecon, 2009, KEMH 18

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)


Intervention: Standard of care?


Methods: Intervention

212 of the trials at ctri

are placebo

controlled


Methods: Intervention (CONSORT)


Methods


Trials registered at clinicaltrials.govaccessed 2nd December 2009

Total: 82,180 trials in 170 countries

USA: 45116 (55%)

1.4%1.4%


Investigator Initiated trials (USA)


U.S. Public Law 110-85 (FDAAA)


www.ctri.inaccessed 2nd December 2009

India 626


India launched Clinical Trials Registry20 Jul 2007


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


Methods


ICMR Guidelines, 2006 IX. Researcher’s relations with the

media and publication


Informed ConsentPara 24

Independent ReviewPara 15

Friday, April 21, 2023 33 Writecon, 2009, KEMH

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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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


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


Methods


Communicating results...


“The file-drawer problem” (Rosenthal, 1979)


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


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


Results and further


Declaration of Helsinki, 2008


declaration of helsinki

Documents

role of medical writers

kemhmethods consort

indian medical journals

biomedical publication

intervention consort

disease burden estimates

publication ethics http

biomedical journals