{"id":3803,"date":"2017-01-20T12:25:56","date_gmt":"2017-01-20T12:25:56","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/F_Sweeney_EMA__WMA_Capetown_2.pdf"},"modified":"2017-01-20T12:25:56","modified_gmt":"2017-01-20T12:25:56","slug":"f_sweeney_ema__wma_capetown_2-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/f_sweeney_ema__wma_capetown_2-2\/","title":{"rendered":"F_Sweeney_EMA__WMA_Capetown_2"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

F_Sweeney_EMA__WMA_Capetown_2<\/a><\/p>\n

An agency of the European Union
\nPresented by: Fergus Sweeney, PhD
\nHead of Sector, Compliance and Inspection, European Medicines Agency.
\nEuropean Medicines Agency
\nPerspective
\nWMA Workshop on revision of DoH, 4-6 Dec 2012,
\nCapetown, South Africa.
\n2
\nDisclaimer
\nThe views presented in this presentation\/these
\nslides are those of the author and should not be
\nunderstood or quoted as being made on behalf of
\nthe European Medicines Agency and\/or its
\nscientific committees
\n3
\nEU requirements for clinical trials conducted in
\nsupport of marketing authorisation submitted to
\nthe EU
\nThis presentation and the documents
\nreferred to relate to the conduct of trials
\nrequired to support MAA in EU
\nRequirements apply:
\n\u2022 To all clinical trials that are included in a MAA submitted in the
\nEU\/EEA
\n\u2013 regardless of the route (Centralised, Mutual Recognition,
\nDecentralised)
\n\u2013 regardless of the EU or third country involved (legislation
\ndoes not differentiate developed, developing etc)
\n\u2022 Apply to the clinical trials included in a MAA
\n\u2022 There is no specific legal framework for review of a clinical
\ntrial dossier by an EU regulator before the conduct of the trial
\nin a third country
\nThe Dilemna\u2026\u2026
\nBetween 2005 and 2011
\n897,891 Patients in pivotal trials
\n(38.11% in Europe, 34.05% in North America, 2.58% Africa,
\n9.36% Middle East\/Asia Pacific, 4.44% CIS, 9.36 % Latin
\nAmerica, 2.1% other)
\n70,291 clinical trial sites in c. 106countries
\nc. 485 new MAA applications plus line extensions etc,
\n265 GCP inspections
\n5
\n0
\n10,000
\n20,000
\n30,000
\n40,000
\n50,000
\n60,000
\n70,000
\n2005 2006 2007 2008 2009 2010 2011
\nNumerofpatients
\nYear of MAA
\nEU\/EEA\/EFTA North America ROW
\nNumber of patients in pivotal trials submitted in MAAs to the EMA per region
\nand year. The data are shown as three \u201cglobal regions\u201d \u2013 EU\/EEA\/EFTA, North
\nAmerica and ROW (Rest of the World).
\n6
\n7
\nTopic 1. Clarify the practical application of ethical standards for clinical
\ntrials, in the context of EMEA activities
\nTopic 2. Determine the practical steps to be undertaken during the
\nprovision of guidance and advice in the drug development phase
\nTopic 3. Determine the practical steps to be undertaken during the
\nMarketing Authorisation phase
\nTopic 4. International cooperation in the regulation of clinical trials, their
\nreview and inspection and capacity building in this area
\nDraft \u2019Reflection paper on ethical and GCP aspects of clinical trials conducted in third
\ncountries for evaluation in marketing authorisation applications for medicines for
\nhuman use, submitted to the EMA\u2019 Public consultation completed 30th September 2010.
\nWorking group \u2013 members from CHMP\/COMP\/PDCO, PCWP, HCPWP, GCP IWG
\nhttp:\/\/www.ema.europa.eu\/Inspections\/docs\/71239709en.pdf
\n8
\nClarification of the practical application of ethical standards for
\nclinical trials on medicinal products for human use in the context
\nof the European Medicines Agency activities
\n\u2022 Local ethics committee and national regulatory
\nauthority oversight
\n\u2022 Information\/Consent procedure
\n\u2022 Confidentiality
\n\u2022 Fair compensation for study related injury
\n\u2022 Vulnerable populations
\n\u2022 Choice of control – placebo and active comparator
\n\u2022 Access to treatment post trial
\n\u2022 Applicability of data to EEA population \u2013 addressed in
\nother guidance
\nVulnerable populations
\nCurrent DoH:
\n17. Medical research involving a disadvantaged or vulnerable population or community is
\nonly justified if the research is responsive to the health needs and priorities of this
\npopulation or community and if there is a reasonable likelihood that this population or
\ncommunity stands to benefit from the results of the research.
\n18. Every medical research study involving human subjects must be preceded by careful
\nassessment of predictable risks and burdens to the individuals and communities involved
\nin the research in comparison with foreseeable benefits to them and to other individuals
\nor communities affected by the condition under investigation.
\n9
\nVulnerable populations
\n\u201cThe inclusion of vulnerable subjects in a clinical trial without the approval of the Ethics Committee and without
\nimplementation of the appropriate consent processes is a serious violation of ethical standards.
\nEU Regulatory Authorities should disregard data obtained in such an unethical manner, when submitted in support of a
\nMAA.\u201d
\n\u2022 In this [clinical trials included in MAAs] context it is mainly vulnerability due to poverty, lack of access to adequate
\nhealth care systems, lack of access to medicines.
\n\u2022 Need to ensure that vulnerable persons or groups are not exploited for the benefit of EU patients.
\n\u2022 At the same time there are the needs to consider the benefit to the patient of taking part in the study
\nand the ethics of potentially turning them away simply because they fit one of the vulnerable categories.
\n\u2022 Denying access to research is also not a solution.
\n\u2022 Information on the populations included in clinical trials in a MAA and any particular concerns should be
\npart of the European Public Assessment report.
\n10
\nAccess to Treatment Post Trial
\nCurrent DoH
\n14. \u2026.. The protocol should describe arrangements for post-study access by study subjects to interventions
\nidentified as beneficial in the study or access to other appropriate care or benefits.
\n33. At the conclusion of the study, patients entered into the study are entitled to be informed about the
\noutcome of the study and to share any benefits that result from it, for example, access to interventions
\nidentified as beneficial in the study or to other appropriate care or benefits
\n11
\nAccess to Treatment Post Trial
\n\u2022 Access to innovative medicinal products varies widely.
\n\u2022 Differences mostly reflect \u2026the \u2026.economic situation and social and health care systems
\nof the country or region.
\n\u2022 Whether the medicinal product is likely to be available in the community or country
\nshould be considered by the sponsor, Ethics Committees and National Regulatory
\nAuthorities. New medicinal products should be intended for marketing in the countries or
\nregions where the clinical trials are conducted.
\n\u2022 For the individual patient who participated in a clinical trial continued access to the
\nproduct that has been identified as beneficial is crucial. It is recognized; however, that
\npost trial access of patients to treatment or medical care provided by sponsor or
\ninvestigator cannot substitute for shortcomings of national or regional health care
\nsystems.
\n12
\nAccess to Treatment Post Trial
\nTransparency on matters of post trial access to treatment and medical
\ncare is paramount for clinical trials submitted to EMA in support of
\nEuropean MAA.
\nThis information will be summarised in the European Public Assessment
\nReport (EPAR).
\n13
\nBiobanks
\nCurrent Declaration of Helsinki
\n\u201c25. For medical research using identifiable human material or data,
\nphysicians must normally seek consent for the collection, analysis,
\nstorage and\/or reuse. There may be situations where consent would
\nbe impossible or impractical to obtain for such research or would
\npose a threat to the validity of the research. In such situations the
\nresearch may be done only after consideration and approval of a
\nresearch ethics committee.\u201d
\n14
\nBiobanks
\n\u2022 Note for Guidance on definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics,
\ngenomic data and sample coding categories (EMEA\/CHMP\/ICH\/437986\/2006)
\n\u2022 Reflection Paper on pharmacogenomics samples testing, testing and data handling
\n(EMEA\/CHMP\/PGxWP\/201914\/2006)
\n\u2022 Reflection paper on pharmacogenomics in Oncology
\n\u2022 Large-scale study of populations may contribute significantly to science\u2019s understanding of the complex
\nmulti-factorial basis of disease and to improvements in prevention, detection, diagnosis, treatment and
\ncure. Pharmacogenomics ( PGx) offer a potential for better understanding the mechanisms of diseases
\nand optimizing the development and use of medicinal products.
\n\u2022 optimize the benefit\/risk balance evaluation
\n\u2022 provide focussed information as guidance to prescribers and patients.
\n\u2022 may become a valuable tool in risk management and pharmacovigilance strategies.
\n15
\nBiobanks
\n\u2022 The use and exchange of human genetic material and the information derived from it, is
\nnot without some controversy. Within the scientific community, there is consensus that
\nprogress in understanding disease will depend on the establishment, harmonisation and
\nbroad use of human biobanks and genetic research databases.
\n\u2022 Human biobanks and genetic research databases which bring together and allow the
\nsharing of human biological material and information derived from its analysis, are a key
\nelement of the scientific infrastructure underpinning such research.
\n\u2022 The potential of the Biotechnology can be developed only if data included in human
\nbiobanks are made available for research.
\n\u2022 The conditions under which the genomic data can be linked back to a subject\u2019s personal
\nidentifiers for any purpose, including the return of genomic data to the subject, should be
\ndescribed in research related documents, e.g. the informed consent document.
\n\u2022 Data protection and confidentiality have to be considered and ensured. In the EU the
\ngeneral data security measures have to correspond to the Directive 95\/46\/EC.
\n16
\nEnhancement (Medical Enhancement)
\nDirective 2001\/83\/EC defines a medicinal product as:
\n\u201cMedicinal product:
\n(a) Any substance or combination of substances presented as having
\nproperties for treating or preventing disease in human beings; or
\n(b) Any substance or combination of substances which may be used in
\nor administered to human beings either with a view to restoring,
\ncorrecting or modifying physiological functions by exerting a
\npharmacological, immunological or metabolic action, or to making a
\nmedical diagnosis.\u201d
\nEMA\u2019s role is to review MAAs for medicines whose proposed function is
\nto treat or prevent disease. The issue of \u201cenhancement\u201d is therefore
\nout of the scope of EMA activities and therefore no comment is
\noffered.17
\nGOAL
\n\u2022Subjects\/patients participating in trials are fully
\nprotected \u2013 wherever the trial takes places
\n\u2022Availability of safe and effective new medicines, as
\nearly as possible, with data relevant to all regions
\n18
\n19
\nThank you<\/p>\n"},"caption":{"rendered":"

F_Sweeney_EMA__WMA_Capetown_2 An agency of the European Union Presented by: Fergus Sweeney, PhD Head of Sector, Compliance and Inspection, European Medicines Agency. European Medicines Agency Perspective WMA Workshop on revision of DoH, 4-6 Dec 2012, Capetown, South Africa. 2 Disclaimer The views presented in this presentation\/these slides are those of the author and should not be […]<\/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\/F_Sweeney_EMA__WMA_Capetown_2.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3803"}],"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=3803"}]}}