{"id":3815,"date":"2017-01-20T12:26:16","date_gmt":"2017-01-20T12:26:16","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/IFPMA_DoH_Cape_Town_6DEC12.pdf"},"modified":"2017-01-20T12:26:16","modified_gmt":"2017-01-20T12:26:16","slug":"ifpma_doh_cape_town_6dec12-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/ifpma_doh_cape_town_6dec12-2\/","title":{"rendered":"IFPMA_DoH_Cape_Town_6DEC12"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

IFPMA_DoH_Cape_Town_6DEC12<\/a><\/p>\n

International Federation
\nof Pharmaceutical
\nManufacturers & Associations
\nExpert Conference on the Revision of the
\nDeclaration of Helsinki
\n\u00a9 IFPMA 2012
\nDecember 6th, 2012
\nCape Town, South Africa
\n2
\nIntroduction
\n\u2022 Biopharmaceutical companies are committed to high-quality ethical
\nresearch
\n\u2013 Principles on Conduct of Clinical Trials and Communication of Clinical
\nTrials Results (PhRMA, 2009)
\n\u2022 IFPMA was invited to participate in this meeting and provide industry
\nexpert input on potential revisions to the Declaration of Helsinki in
\n2014
\n\u2022 Keeping in mind that the original purpose of the Declaration of
\nHelsinki was to serve as a set of guiding principles for physicians
\ninvestigators, IFPMA has developed points for consideration on the
\nfollowing topics:
\n\u2013 Use of placebo in clinical trials
\n\u2013 Use of comparators based on differences in standard of care and
\navailability of medicines between developed, emerging and
\ndeveloping countries
\n\u2013 Conduct of clinical trials in vulnerable patient populations
\n\u2013 Post-study access to medical care
\n3
\n\u2022 Use of placebo in clinical trials
\n\u2013 Principle 32
\n\u2022 Use of comparators based on differences in standard
\nof care and availability of medicines between
\ndeveloped, emerging and developing countries
\n\u2013 Principles 32 and 35
\n\u2022 Conduct of clinical trials in vulnerable patient
\npopulations
\n\u2013 Principles 9 and 17
\n\u2022 Post-study access to medical care
\n\u2013 Principle 14
\n\u2022 Placebo-controlled trials allow researchers to reliably evaluate
\nsafety and efficacy of an experimental treatment while minimizing
\nthe number of necessary participants exposed to the treatment
\n\u2022 Regulatory authorities often require the use of placebo as a
\ncomparator in clinical trials
\n\u2022 The use of placebo as an acceptable comparator for new
\ntreatments tested in clinical trials is acknowledged and
\naddressed by:
\n\u2013 Council for International Organizations of Medical Sciences (CIOMS)
\n\u2022 International Ethical Guidelines for Biomedical Research Involving Human
\nSubjects (2002, Guideline 11)
\n\u2013 The International Conference on Harmonization of Technical Requirements
\nfor Registration of Pharmaceuticals for Human Use (ICH)
\n\u2022 Choice of control group and related issues in clinical trials E10 (2000)
\n\u2013 Presidential Commission for the Study of Bioethical Issues
\n\u2022 Moral Science. Protecting Participants in Human Subjects Research (2011,
\nRecommendation 12)
\n4
\nUse of Placebo in Clinical Trials
\nBackground
\nUse of Placebo in Clinical Trials
\nPoints for Consideration
\n\u2022 Potential scientific, regulatory, and ethical issues associated with the
\nuse of placebo or any other appropriate comparator should be
\ncarefully assessed in the context of each trial
\n\u2022 When a proven effective therapy exists, and the use of placebo as
\ncomparator is scientifically necessary and ethically acceptable, it
\nmight be valuable, in some instances, to address in the protocol:
\n\u2013 Rationale for selecting placebo as the appropriate single or add-on
\ncomparator
\n\u2013 The potential consequences for participants in the placebo arm of not
\nreceiving a proven effective therapy (when placebo is used as the single
\ncomparator)
\n\u2013 Safeguards whenever appropriate (for example: rescue medication,
\nrandomized withdrawal design with patient discontinuation criteria, data
\nand safety monitoring board)
\n\u2022 The concept of not exposing patients receiving placebo in clinical
\ntrials to \u201cany risk\u201d of serious harm should be defined more clearly in
\nthe Declaration of Helsinki 5
\n6
\n\u2022 Use of placebo in clinical trials
\n\u2013 Principle 32
\n\u2022 Use of comparators based on differences in standard
\nof care and availability of medicines between
\ndeveloped, emerging and developing countries
\n\u2013 Principles 32 and 35
\n\u2022 Conduct of clinical trials in vulnerable patient
\npopulations
\n\u2013 Principles 9 and 17
\n\u2022 Post-study access to medical care
\n\u2013 Principle 14
\nUse of Comparators Based on Differences
\nin Standard of Care and Availability of Medicines
\nBackground
\n\u2022 Selection of comparators based on local or regional standards of care is
\naccepted and acknowledged by:
\n\u2013 Council for International Organizations of Medical Sciences (CIOMS)
\n\u2022 Introduction and Commentary on Guideline 11 (2002)
\n\u2013 Nuffield Council on Bioethics (NCOB)
\n\u2022 The ethics of research related to healthcare in developing countries (2002,
\nparagraph 7.29)
\n\u2013 National Bioethics Advisory Commission (NBAC)
\n\u2022 Ethical and Policy Issues in International Research: Clinical Trials in
\nDeveloping Countries (2001, Volume I)
\n\u2013 Presidential Commission for the Study of Bioethical Issues
\n\u2022 Moral Science. Protecting Participants in Human Subjects Research (2001,
\nRecommendation 12)
\n\u2013 Council of Europe (CoE)
\n\u2022 Additional Protocol to the Convention on Human Rights and Biomedicine,
\nconcerning Biomedical Research (2004, paragraph 120)
\n7
\nUse of Comparators Based on Differences
\nin Standard of Care and Availability of Medicines
\nPoints for Consideration
\n\u2022 Selection of an active comparator when conducting
\nmultiregional trials in developed and emerging or
\ndeveloping countries should take into consideration:
\n\u2013 Whether the comparator can be considered scientifically and ethically acceptable
\nfor the patient population\/s regardless of where the study is conducted
\n\u2013 Healthcare needs of the country
\n\u2013 Medical and logistical infrastructure
\n\u2013 Medical practices
\n\u2013 Compliance with local regulations
\n\u2013 Genetic differences that may alter responses to medications
\n\u2022 The concept of \u201cbest proven intervention\u201d should be
\nreconsidered to address internal discrepancies within the
\ndocument (e.g. between principles 32 and 35), and to achieve
\nbetter alignment with other major ethical guidance documents
\n\u2013 \u201cBest proven\u201d could be defined as \u201cestablished effective intervention\u201d or \u201cbest
\nlocally proven intervention\u201d (e.g. referenced to the local standard of care)
\n8
\n9
\n\u2022 Use of placebo in clinical trials
\n\u2013 Principle 32
\n\u2022 Use of comparators based on differences in standard
\nof care and availability of medicines between
\ndeveloped, emerging and developing countries
\n\u2013 Principles 32 and 35
\n\u2022 Conduct of clinical trials in vulnerable patient
\npopulations
\n\u2013 Principles 9 and 17
\n\u2022 Post-study access to medical care
\n\u2013 Principle 14
\nClinical Trials in Vulnerable Patient Populations
\nBackground
\n\u2022 The inclusion of vulnerable patient populations in clinical trials often raises
\nconcerns about their:
\n\u2013 Reduced ability to protect their own interests
\n\u2013 Limited capacity or freedom to consent or to decline to consent
\n\u2022 Vulnerable patient populations include a diverse group of people who may
\nbenefit from the development of new medical treatments, for example:
\n\u2013 Pregnant women
\n\u2013 Extreme of ages (e.g. children, elderly)
\n\u2013 Those with impaired cognitive functions
\n\u2013 Persons with life-threatening diseases or in emergency clinical situations
\n\u2013 Those who are in a dependent situation or deprived of liberty
\n\u2013 Those who may lack access to health care
\n\u2022 The inclusion of vulnerable patient populations in clinical trials is
\nacknowledged and addressed by:
\n\u2013 Nuffield Council on Bioethics (NCOB)
\n\u2022 The ethics of research related to healthcare in developing countries (2002, paragraphs 4.19-
\n4.21)
\n\u2013 Council for International Organizations of Medical Sciences (CIOMS)
\n\u2022 International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002,
\nGuideline 13)
\n10
\nClinical Trials in Vulnerable Patient Populations
\nPoints for Consideration
\n\u2022 Clinical trials in vulnerable patient populations are necessary to
\ngenerate rigorous and reliable information about potential benefits
\nand risks of treatments, and to increase the validity of the results
\n\u2022 When conducting clinical trials in vulnerable patient populations
\nparticular attention should be given, for example, to:
\n\u2013 Ethical justifications for their inclusion
\n\u2013 Risks of undue influence, abuse or coercion
\n\u2013 Respect for their dignity, rights, safety and welfare, local norms and
\nculture
\n\u2013 Expertise and experience required to conduct the clinical study
\n\u2013 Challenges of the consent\/assent process
\n\u2013 Role of legal\/authorized representative
\n\u2022 Sustained collaboration between patients\u2019 associations and
\ncommunities, industry, academia, regulators, and disease advocacy
\ngroups is important to encourage participation by vulnerable patient
\npopulations in clinical trials, while ensuring their full protection as
\nresearch participants 11
\n12
\n\u2022 Use of placebo in clinical trials
\n\u2013 Principle 32
\n\u2022 Use of comparators based on differences in standard
\nof care and availability of medicines between
\ndeveloped, emerging and developing countries
\n\u2013 Principles 32 and 35
\n\u2022 Conduct of clinical trials in vulnerable patient
\npopulations
\n\u2013 Principles 9 and 17
\n\u2022 Post-study access to medical care
\n\u2013 Principle 14
\nPost-study Access to Medical Care
\nBackground
\n\u2022 Limited clarity is provided in the Declaration of
\nHelsinki or other ethical guidance documents about:
\n\u2013 What constitutes post-study medical care
\n\u2013 Which population\/s should receive post-study access to
\nmedical care
\n\u2013 Who is responsible to provide post-study access to medical
\ncare
\n\u2013 When post-study access to medical care could\/should end
\n\u2022 Our comments relate to post-study access to study
\nmedications
\n13
\nPost-study Access to Medical Care
\nPoints for Consideration
\n\u2022 Post-study access to medicines being studied for an approved indication is the
\nresponsibility of the applicable government agency or other payer as per usual
\nhealthcare programs
\n\u2013 Sponsor is not responsible for any continued healthcare costs for diseases\/conditions that
\ncontinue beyond the end of such study
\n\u2022 The sponsor may offer post-study access to the study medication in
\ncircumstances (for example, life-threatening diseases, clinical emergencies)
\nwhere no appropriate alternative therapies are available locally:
\n\u2013 Subject to local legal and regulatory requirements
\n\u2013 Guided by best available evidence for a favorable benefit\/risk profile
\n\u2013 Plan for post-study access (including discontinuation) should be guided by the documented
\npre-trial agreement and any potential modifications
\n\u2022 In cases where the sponsor plans to provide post-study access to the study
\nmedication, supply may be discontinued if:
\n\u2013 In the sponsor\u2019s opinion, new information becomes available that affects negatively the
\nprevious benefit\/risk assessment of the medication
\n\u2013 The reviewing agency rejects the request for marketing authorization based upon an
\nassessment of benefit\/risk and there are no further plans to seek authorization
\n\u2013 In all circumstances, the sponsor will work with relevant local authorities and caregivers in the
\nbest interest of the research participants
\n14<\/p>\n"},"caption":{"rendered":"

IFPMA_DoH_Cape_Town_6DEC12 International Federation of Pharmaceutical Manufacturers & Associations Expert Conference on the Revision of the Declaration of Helsinki \u00a9 IFPMA 2012 December 6th, 2012 Cape Town, South Africa 2 Introduction \u2022 Biopharmaceutical companies are committed to high-quality ethical research \u2013 Principles on Conduct of Clinical Trials and Communication of Clinical Trials Results (PhRMA, 2009) \u2022 […]<\/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\/IFPMA_DoH_Cape_Town_6DEC12.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3815"}],"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=3815"}]}}