{"id":3741,"date":"2017-01-20T11:53:22","date_gmt":"2017-01-20T11:53:22","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Demotes.pdf"},"modified":"2017-01-20T11:53:22","modified_gmt":"2017-01-20T11:53:22","slug":"demotes-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/demotes-2\/","title":{"rendered":"Demotes"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Demotes<\/a><\/p>\n

WMA Satellite Meeting during the 11th World Congress of Bioethics:
\nThinking ahead \u2013 The future of the Declaration of Helsinki
\nJune 26th 2012, Rotterdam, The Netherlands
\nECRIN proposals for amendments to the
\nDeclaration of Helsinki: ethics committees,
\ntransparency, and choice of comparator
\nRita Banzi, Vittorio Bertel\u00e9, Xavier Carn\u00e9, Jacques Demotes-Mainard,
\nSilvio Garattini, Christian Gluud
\nJacques Demotes
\njacques.demotes@inserm.fr
\nwww.ecrin.org
\nECRIN, an infrastructure supporting
\ninternational cooperation in clinical
\ntrials
\nA pan-European, distributed
\ninfrastructure providing coordinated
\nservices to multinational clinical
\nresearch in Europe:
\n\uf0d8 access to patients and to expertise
\nthroughout Europe
\n\uf0d8 despite the fragmentation of health,
\nlegislative and funding systems
\n\uf0d8 support to investigators and sponsors
\nin multinational studies
\n\uf0d8 to make Europe a single area for
\nclinical research
\nSuggestions to improve the
\nDeclaration of Helsinki
\n\uf0d8 Ethics Committees
\n1 \u2013 training of ethics committee members (\u00a715)
\n2 \u2013 independence of the research ethics committees (\u00a715)
\n\uf0d8 Transparency
\n3 \u2013 protocol, raw data, recruitment, incentives (\u00a730)
\n\uf0d8 Trial design
\n4 \u2013 methodology based on systematic reviews (\u00a712).
\n5 \u2013 use of placebo (\u00a732) based on medical grounds
\n6 \u2013 ethical dimension of non-inferiority and equivalence trials
\n\uf0d8 Wording
\n7 \u2013 \u2018participants\u2019 instead of \u2018subjects\u2019
\nEthics Committees:
\ntraining and independence
\n1 \u2013 training of ethics committee members (\u00a715)
\nrequired to ensure credibility and reproducibility of their
\ndecisions, a critical issue in multinational trials.
\n2 \u2013 independence of the research ethics committees (\u00a715)
\n\u201cThis committee must be independent of the researcher,
\nthe sponsor and any other undue influence\u201d.
\nchallenged when linked to an institution that is also be the
\ninitiator or sponsor of a clinical trial.
\nTransparency
\n3 \u2013 Authors, editors and publishers all have ethical obligations with regard to the
\npublication of the results of research. Authors have a duty to make publicly available
\nthe results of their research on human subjects and are accountable for the
\ncompleteness and accuracy of their reports. They should adhere to accepted
\nguidelines for ethical reporting. Negative and inconclusive as well as positive results
\nshould be published or otherwise made publicly available. Sources of funding,
\ninstitutional affiliations and conflicts of interest should be declared in the
\npublication\u2026 (\u00a730)
\n– 20-item registration
\n– Publication of results
\n– Registration of full protocol and amendments
\n– Access to raw, anonymised data Hrynaszkiewicz and Altman Trials 2009,10:17
\n– optimal use of data (repository ?)
\n– credibility and quality of the trial
\n– Recruitment performance Dal Re et al. PLoS Medicine 2011, 8:e1001149
\n– Incentives
\nECRIN Scientific Board:
\nAcceptance criteria
\n1 – Multicentre trial run in at least two European countries.
\n2 – Rules for transparency:
\n– Commitment to register the trial in a public register before inclusion of the
\nfirst participant, for example on www.clinicaltrials.gov.
\n– Commitment to publish results irrespective of findings.
\n– Commitment to make raw anonymised data sets available to the scientific
\ncommunity upon legitimate request to the sponsor or principal investigator
\nonce the trial is completed.
\n– Declaration of conflicts of interest.
\n3 – Rationale based on up-to-date systematic reviews of clinical data or, where not
\npossible, of preclinical data on the experimental intervention and comparator.
\n4 – Clinical relevance and\/or marked impact on public health.
\n5 – Suitable overall trial design appropriate to the clinical question, including for
\nexample:
\n– Selection of an appropriate and justified experimental intervention and
\ncomparator.
\n– Adequate sample size with supporting calculation.
\n– Relevant patient population (inclusion and exclusion criteria), setting, and
\nduration of treatment and follow up.
\n– Outcome measures for efficacy and safety with clinically meaningful benefit
\nfor the patient.
\nDesign: the clinical relevance should
\nprevail over statistical considerations
\nClinical relevance is the goal,
\nstatistics is an instrument
\n4 \u2013 methodology based on
\nsystematic reviews (\u00a712).
\nMedical research involving human
\nsubjects must conform to generally
\naccepted scientific principles, be
\nbased on a thorough knowledge of
\nthe scientific literature, other
\nrelevant sources of information, and
\nadequate laboratory and, as
\nappropriate, animal
\nexperimentation.
\nDesign: the clinical relevance should
\nprevail over statistical considerations
\n5 \u2013 use of placebo (\u00a732) based on medical grounds:
\nthe improper use of placebo harms the participants
\nBertel\u00e9 et al. J Clin Pharmacol. 2012, 68:877-9
\nThe benefits, risks, burdens and effectiveness of a new intervention must be tested
\nagainst those of the best current proven intervention, except in the following
\ncircumstances:
\n– The use of placebo, or no treatment, is acceptable in studies where no current
\nproven intervention exists; or
\n– Where for compelling and scientifically sound methodological reasons the use of
\nplacebo is necessary to determine the efficacy or safety of an intervention and the
\npatients who receive placebo or no treatment will not be subject to any risk of
\nserious or irreversible harm. Extreme care must be taken to avoid abuse of this
\noption.
\nDesign: the clinical relevance should
\nprevail over statistical considerations
\n6 \u2013 ethical dimension of non-inferiority and equivalence trials:
\nGarattini & Bertel\u00e9, Lancet 2007, 370:1875-7
\nparticipants take risks without expected benefits
\n\uf0d8 explicitly mentioned in the informed consent sheet
\nFerran.Torres@uab.es 10
\n0
\nLower equivalence
\nboundary
\nUpper equivalence
\nboundary
\nTreatment more effective -><- Treatment less effective\n2\n3\n4\n5\nTreatment-Control\n1\nSuperiority\nFerran.Torres@uab.es 11\n0\nLower equivalence\nboundary\nUpper equivalence\nboundary\nTreatment more effective -><- Treatment less effective\n2\n3\n4\n5\nTreatment-Control\n1\nEquivalence\nFerran.Torres@uab.es 12\n0\nLower equivalence\nboundary\nUpper equivalence\nboundary\nTreatment more effective -><- Treatment less effective\n2\n3\n4\n5\nTreatment-Control\n1\nNon-Inferiority\nFerran.Torres@uab.es 13\n0\nLower equivalence\nboundary\nUpper equivalence\nboundary\nStatistical Superiority\nNon-inferiority\nEquivalence\nInferiority\nTreatment-Control\nStatistically and\nClinically superiority\nStatistically and Clinically Superiority\nNon relevant\/negative effect relevant effect\nWording\n7 \u2013 \u2018participants\u2019 instead of \u2018subjects\u2019 or \u2018cases\u2019\nThank you !\n\n<\/p>\n"},"caption":{"rendered":"

Demotes WMA Satellite Meeting during the 11th World Congress of Bioethics: Thinking ahead \u2013 The future of the Declaration of Helsinki June 26th 2012, Rotterdam, The Netherlands ECRIN proposals for amendments to the Declaration of Helsinki: ethics committees, transparency, and choice of comparator Rita Banzi, Vittorio Bertel\u00e9, Xavier Carn\u00e9, Jacques Demotes-Mainard, Silvio Garattini, Christian Gluud […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Demotes.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3741"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3741"}]}}