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1 Where science and ethics meet Interaktiver GCP- Kurs und Prüfarzttraining 23 & 24. März 2011 Bonn, Deutschland -

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3 The European Forum for Good Clinical Practice where science and ethics meet Interaktiver GCP-Kurs und Prüfarzttraining AGENDA Mittwoch, 23. März :00 Die Entwicklung der GCP-Grundsätze 09:20 Vom ICH-GCP-Standard zur deutschen Gesetzgebung für klinische Prüfungen, Diskussion 09:55 Ethische Begutachtung und Ethikkommissionen, Diskussion 11:05 Kaffeepause 11:30 Die deutsche Gesetzgebung für klinische Prüfungen, Diskussion 12:30 Mittagspause 13:30 Vorbereitung einer klinischen Prüfung im Prüfzentrum, Diskussion 14:45 Qualitätsmanagement in klinischen Prüfungen, Diskussion 15:30 Kaffeepause 16:00 Grundsätze des Dokumenten-Managements, Diskussion 17:00 Ende Tag 1 Donnerstag, 24. März :30 Einschluss von Studienteilnehmern in klinische Prüfungen, Diskussion 09:15 Wichtige Aspekte bei der Durchführung klinischer Studien, Diskussion 10:15 Kaffeepause 10:45 Was passiert, wenn es schiefläuft? Diskussion 11:15 Zuverlässige Meldung von Nebenwirkungen 12:00 Abschluss-Quiz 12:30 Ende des Workshops

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5 where science and ethics meet PRESENTATION OF THE EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE INTRODUCTION The European Forum for Good Clinical Practice (EFGCP) was founded during a conference at the European Parliament in 1993 with the support of the European Commission. Since its creation, EFGCP has functioned as a leading European think tank for discussion, research, and critical evaluation in the development of European health research. EFGCP is a non-profit organisation established by and for individuals with a professional involvement in the conduct of biomedical research. Its purpose is to promote Good Clinical Practice (GCP) and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe. VISION Promote medical and pharmaceutical progress in Europe and elsewhere by fostering partnerships between groups and entities involved in clinical science and ethics across disciplines and cultures. MISSION EFGCP s mission is to promote the interests of patients in clinical research through the development of European ethical and scientific standards. The EFGCP provides a common meeting ground for the many disciplines and organisations affected by GCP. The primary aims of the EFGCP are to promote the highest standards for Good Clinical Practice (GCP) in Europe and abroad, to promote open discussion on critical issues in biomedical research and health, to promote education and awareness leading to the application of rigorous ethical and scientific requirements in clinical research, to facilitate the transfer of knowledge and skills across disciplines and sectors, to promote a renewed emphasis on human values in research involving human participants.

6 The EFGCP is a European organisation with a global vision. This is reflected in the many collaborative partnerships it has developed with European, North American and International Research patient, research, and regulatory organisations. FUNDING The basic source of funds for the EFGCP is membership fees. Additional funding for specific EFGCP activities is developed according to the objectives and scope of the activity concerned. In order to maintain its independence and high ethical standards, the EFGCP actively seeks funding across a wide range of funding organisations, including public (i.e. EU funded-projects) and private institutions. All EFGCP financial engagements are guided by the principles of independence in decision-making and transparency. STRUCTURE MEMBERSHIP Membership in the EFGCP is open to professionals and individuals, representing patient groups, ethics committees, academic & industry research enterprises, regulatory officials, and those concerned to develop Good Clinical Practice in Europe. BOARD The EFGCP is governed by a Board of Directors. The Board has responsibility for providing leadership, policy-making, and financial decision-making in accordance with the Charter of Incorporation. Board members are elected by the EFGCP General Assembly. The members are elected for a term of 3 years, which is renewable. The Board is responsible to ensure that the EFGCP is managed to continually comply with the ethical and scientific standards required for providing European leadership in Good Clinical Practice.

7 SCIENCE & ETHICS COUNCIL The EFGCP Science & Ethics Council is composed of leading European and international experts representing major institutions affecting the regulation and practices of Good Clinical Practice. It pools the efforts of the Board including the Working Parties chairpersons and the previous Advisory Council under one same roof. Although the executive power of the EFGCP continues to rest with the Board, the Council takes the lead in matters of Science and Ethics. The Working Parties which would like to broaden their activities, issue more position papers and propose topics for conference receive recommendations and approval from the new Council. The Science & Ethics Council contributes to the development of the EFGCP by increasing input into EFGCP planning and projects, extending the EFGCP basis of expertise and competence, and increasing the awareness and recognition of the contributions to GCP made by the EFGCP. The Science and Ethics Council sees to optimally reflect the various components of the clinical research community: the patient associations, the sponsors, the CROs, the investigators and their networks, the ethics committees and the authorities. By itself, the new Council with 2 meetings a year will provide a unique opportunity for Forum discussions. The members of the Science & Ethics Council are regularly invited to participate in EFGCP Events either as experts in particular subjects or in advisory capacity for developing the events WORKING PARTIES The EFGCP Working Parties serve as the central reference point for EFGCP research and the development of European guidances, reports, and publications in the area of Good Clinical Practice. The Working Parties are composed of EFGCP members with expertise and interest in contemporary areas such as the ethics, science, and regulation of clinical research in Europe and globally. The following six Working Parties are active: Ethics Working Party Audit Working Party Education Working Party Children's Medicines Working Party Geriatric Medicines Working Party Patients Roadmap to Treatment Working Party (in collaboration with the European Genetic Alliance Network EGAN) BUREAU The EFGCP Secretariat is the organisational arm of the EFGCP responsible for all the operations of the association and its membership services. The EFGCP events are also managed internally.

8 ACTIVITIES To fulfill its mission it is necessary for the EFGCP to organise relevant activities. Activities include Conferences, Workshops, Working Parties, Research Projects (FP6/FP7/IMI), Website, Newsletter and other publications. PUBLICATIONS EFGCP is dedicated to bringing leading publications on GCP in Europe and abroad. The EFGCP publishes its own newsletter, The EFGCP News, quarterly as well as a number of European guidelines and key reports (Annual update of the EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe, freely available on the website) CONFERENCES & WORKSHOPS Since its creation, EFGCP has been organising a significant number of conferences and workshops which consist in high level forum discussions characterised by interactive debates on a specific topic with the major stakeholders in the selected area. Among the organisations that have participated in projects led by the EFGCP are the European Commission, the European Parliament, EMA, EORTC, ESF, EAP, EPPOSI, EuropaBio, EFPIA, ICH, BARQA, WMA, CIOMS, the Faculty of Pharmaceutical Medicine, etc. Please consult the list of past events for further details. OFFICE & CONTACT PERSON: Fanny Senez Chief Operating Officer EFGCP Secretariat Square de Meeûs Rue de l Industrie 4 B-1000 Brussels Belgium Tel Fax Website: FOR MORE DETAILS ON EFGCP, PLEASE VISIT OUR WEBSITE:

9 Where science & ethics meet CV OF EFGCP EXPERT Dr. med. Ingrid KLINGMANN FFPM, studied medicine in Germany and specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine. After having joined pharmaceutical industry as medical advisor, she held senior management positions in different international contract research organisations and was responsible for operational, scientific, regulatory and business aspects of international clinical research projects from Phase I to Phase IV. Since January 2003 she has her own pharmaceutical development and site management support consulting company. From January 2004 to July 2007 she was also CEO of two investigative sites in London, UK, performing clinical trials in acute and chronic pain as well as musculo-skeletal diseases. Dr. Klingmann is a founding member and Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP) as well as Co-Chair of the EGAN/EFGCP Working Party Patients Roadmap to Treatment. On behalf of EFGCP she was the Project Coordinator for the FP7-funded ICREL project. She is a founding member of the Association for Applied Human Pharmacology (AGAH) in Germany where she also established and chaired the Ethics Working Party of this organisation dealing with ethics and GCP issues in Human Pharmacology in Germany; today she is chairing AGAH s regulatory affairs working party and is President; and in the Drug Information Association (DIA) she was a member of the Steering Committee Europe (now Advisory Council Europe), a former chair person of the SCE, a Member of the Board, a Member of the Foundation Board, and speaker, session chair and programme committee member for numerous conferences of the DIA. Dr. Klingmann chairs the clinical research module of the post-graduate Master in Regulatory Affairs course at the University of Bonn, Germany as well as the Diploma Course in Clinical Trail Practices at the University of Basel, Switzerland.

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11 Die Entwicklung der GCP-Grundsätze

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13 Interaktiver GCP-Kurs und Prüfarzttraining Dr. med. Ingrid Klingmann Pharmaplex bvba Brüssel, Belgien Die Entwicklung der GCP-Grundsätze Dr. med. Ingrid Klingmann Material erstellt in Zusammenarbeit mit Prof. Dr. JanHasker G. Jonkman University of Groningen, The Netherlands CONTENT GOOD CLINICAL PRACTICE (GCP): ICH DEFINITION OF GCP DECLARATION OF HELSINKI IMPORTANT ASPECTS OF GCP ICH GUIDELINE FOR GCP OTHER GUIDELINES CONCLUSIONS 3/37

14 GOOD CLINICAL PRACTICE (GCP): ICH (1) Key document for Good Clinical Practices Guideline for Good Clinical Practice (Topic E6) International Conference on Harmonisation (ICH) = NEW WORLD STANDARD Since /37 GOOD CLINICAL PRACTICE (GCP): ICH (2) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (first meeting in 1991, Brussels, Belgium): Objectives: more economical use of human, animal and material resources elimination of unnecessary delay in the global development and availability of new medicines, maintaining safeguards on quality, safety and efficacy and regulatory obligations to protect public health 5/37 GOOD CLINICAL PRACTICE (GCP): ICH (3) 6/37 Composition: representatives of regulatory agencies and pharmaceutical industries of triad: EU USA Japan Observers of: WHO Canada EFTA

15 GOOD CLINICAL PRACTICE (GCP): ICH (4) ICH GCP implementation: European Union Guideline for Good Clinical Practice (Topic E6) CPMP/ICH/135/95 (final July 17, 1996; effective January 17, 1997) Website: 7/37 (NB: it is a guideline, not a law; has to be incorporated in national laws of member states) 8/36 GOOD CLINICAL PRACTICE: DEFINITION (1) (ICH, 1996) Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. 9/37

16 GOOD CLINICAL PRACTICE: DEFINITION (2) (ICH, 1996) Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. 10/37 GOOD CLINICAL PRACTICE (ICH) (1) BASED ON (1): World Medical Association Declaration of Helsinki Recommendations guiding physicians in biomedical research involving human subjects First version: 1964 Revised six times since then Most recent version: 2008 (Seoul) 11/37 GOOD CLINICAL PRACTICE (ICH) (2) BASED ON (2): 12/37

17 DECLARATION OF HELSINKI: OBJECTIVES Protection of the rights and safety of human subjects (including protection of privacy) Integrity of data (to prevent fraud) Transparency of conduct of a study (traceability) Reproducible data 13/37 IMPORTANT ASPECTS OF GCP IN GENERAL (1) Strategic planning Standard Operating Procedures Ethics Committee Approval Informed Consent (free will) 14/37 IMPORTANT ASPECTS OF GCP IN GENERAL (2) Well-designed study (Study Protocol; official document) 15/37

18 16/36 IMPORTANT ASPECTS OF GCP IN GENERAL (3) Highly skilled Investigator (documented training!) Well-controlled research equipment (good infrastructure) Monitoring Control of study medication (drug accountability) 17/37 IMPORTANT ASPECTS OF GCP IN GENERAL (4) Good documentation of all stages of study (with change control!) Integrity of data Quality Assurance Archives 18/37

19 IMPORTANT ASPECTS OF GCP IN GENERAL (5) MOST IMPORTANT ASPECT: NOT DOCUMENTED = NOT DONE 19/36 20/36 21/37

20 ICH GUIDELINE FOR GCP (1) Divided into: Glossary The Principles of ICH GCP Institutional Review Board/Independent Ethics Committee (IRB/IEC) Investigator Sponsor Clinical Trial Protocol and Protocol Amendment(s) Investigator s Brochure Essential documents for the conduct of a clinical trial 22/37 ICH GUIDELINE FOR GCP (2) THE PRINCIPLES OF ICH GCP (1): 1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s). 2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. 23/37 ICH GUIDELINE FOR GCP (3) THE PRINCIPLES OF ICH GCP (2): 3. The rights, safety and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. 4. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. 5. Clinical trials should be scientifically sound; and described in a clear, detailed protocol. 24/37

21 ICH GUIDELINE FOR GCP (4) THE PRINCIPLES OF ICH GCP (3): 6. A trial should be conducted in compliance with the protocol that has received prior Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approval / favourable opinion. 25/37 ICH GUIDELINE FOR GCP (5) THE PRINCIPLES OF ICH GCP (4): 7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. 8. Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). 27/37

22 ICH GUIDELINE FOR GCP (6) THE PRINCIPLES OF ICH GCP (5): 9. Freely given informed consent should be obtained from every subject prior to clinical trial participation. 10. All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification. 28/37 ICH GUIDELINE FOR GCP (7) THE PRINCIPLES OF ICH GCP (6): 11. The confidentiality of records that could identify subjects should be protected respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). 12. Investigational products should be manufactured, handled and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol. 29/37 ICH GUIDELINE FOR GCP (8) THE PRINCIPLES OF ICH GCP (7): 13. Systems with procedures that assure the quality of every aspect of the trial should be implemented. 30/37

23 ICH GUIDELINE FOR GCP (9) Who is responsible? Research Ethics Committee Quality and GCPcompliance Data accuracy and integrity Protection of study subject X - X Investigator X X X Sponsor X X X Monitor X X - 31/37 OTHER GUIDELINES (1) LEGISLATION EUROPE Directive 20/2001/EC ( Clinical Trials Directive ) Directive 28/2005/EC ( Good Clinical Practice Directive ) and several Guidances of the European Union 32/37 OTHER GUIDELINES (2) USA Many laws, guidances that have to be obeyed when performing studies for market authorisation in the USA. 33/37

24 OTHER GUIDELINES (3) BUT: The most important guideline is: USE YOUR COMMON SENSE! 34/37 CONCLUSIONS (1) There are differences in different countries but harmonisation (ICH) is imminent. ICH Guideline for GCP is nowadays world standard. EU Directive 2001/20/EC ( Clinical Trials Directive ) and Directive 2005/28/EC ( GCP Directive ) will have great impact. 35/37 CONCLUSIONS (2) GCP contributes to better protection of study participants through Evaluation / approval of protocol by Medical Ethics Committee Only participation after written consent of subject Surveillance of adverse events Protection of privacy of participants 36/37

25 CONCLUSIONS (3) GCP contributes to better reproducible and more reliable data (less misconduct and/or fraud) through Strict compliance with Study Protocol Full documentation of all stages of the study (not documented = not done) Implementation of quality management system SOP s Training In-process quality control Audits by independent Quality Assurance Department Drug accountability 37/37 Archiving

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27 Vom ICH-GCP-Standard zur deutschen Gesetzgebung für klinische Prüfungen

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29 VOM ICH-GCP-STANDARD ZUR DEUTSCHEN GESETZGEBUNG FÜR KLINISCHE PRÜFUNGEN Dr. med. Ingrid Klingmann Material erstellt in Zusammenarbeit mit Dr. Frank Wells Consultant Pharmaceutical Physician Ipswich, UK CONTENT What is GCP? History, from the 1930s to the 1990s History, from the 1990s onwards The EC Directives GCP today GCP implementation in German legislation 2/29 Mar /36 3/29 Mar 2011

30 HISTORY (6) 1990s: (a) The International Conference on Harmonisation of Regulatory Requirements for Pharmaceuticals (ICH) was established (1990). The topics selected for harmonisation would be divided into Safety, Quality and Efficacy, with Expert Working Groups discussing the scientific and technical aspects of each harmonisation topic. (b) The World Health Organisation (WHO) published its GCP Guidelines (1995). (c) ICH published its GCP Consolidated Guideline (1996). 4/29 Mar 2011 WHAT IS GCP? Good Clinical Research Practice (GCP) incorporates established ethical and scientific standards for the overall conduct of clinical research projects in human subjects. Compliance with GCP provides public assurance that the research subjects are protected and respected, consistent with the Declaration of Helsinki and other internationally recognised ethical guidelines and ensures the integrity of clinical research data. 5/29 Mar 2011 WHAT IS GCP? The responsibility for GCP is shared by sponsors, investigators and site staff, contract research organisations (CROs), research ethics committees, regulatory authorities and research subjects. 6/29 Mar 2011

31 HISTORY (1) 1930s: A tragic mistake in the formulation of a children's syrup in the USA was the trigger for setting up the product authorisation system under the Food and Drug Administration. 1947: The Nuremberg Code, considered the first document that set out the ethics of experiments involving humans, emphasised the principles of informed consent. 1950s: Government regulations requiring all medicinal products to be registered for sale started in Japan. 7/29 Mar 2011 HISTORY (2) 1960s: The thalidomide tragedy revealed, in many countries in Europe, that the new generation of synthetic drugs, which were revolutionising medicine at the time, had the potential to harm as well as heal. 1964: The World Medical Association published the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. 8/29 Mar 2011 HISTORY (3) 1970s: A rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products. But there was no harmonisation or rationalisation. 9/29 Mar 2011

32 HISTORY (4) 1980s: (a) Several different pharmaceutical companies developed guidelines on how to conduct clinical trials. (b) Harmonisation of regulatory requirements was pioneered by the European Community, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals. 10/29 Mar 2011 HISTORY (5) 1980s: (c) In 1986 the Association of the British Pharmaceutical Industry (ABPI) published policy guidelines on Good Clinical Research Practice. 11/29 Mar s: HISTORY (6) (a) The International Conference on Harmonisation of Regulatory Requirements for Pharmaceuticals (ICH) was established (1990). The topics selected for harmonisation would be divided into Safety, Quality and Efficacy, with Expert Working Groups discussing the scientific and technical aspects of each harmonisation topic. (b) The World Health Organisation (WHO) published its GCP Guidelines (1995). (c) ICH published its GCP Consolidated Guideline (1996). 12/29 Mar 2011

33 THE EUROPEAN UNION (1) 1965: Council Directive 65/65/EEC required the submission of a dossier containing the results of tests and clinical trials. 1975: Council Directive 75/318/EEC laid down uniform rules on the presentation of such dossiers. 13/29 Mar 2011 THE EUROPEAN UNION (2) 2001: Directive 2001/20/EC of the European Commission relates to the implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use. [The Clinical Trials Directive] 2005: Directive 2005/28/EC of the European Commission lays down principles and detailed guidelines for good clinical practice (GCP) as regards investigational medicinal products for human use. [The GCP Directive] 14/29 Mar 2011 THE EUROPEAN UNION (3) The legislations released by the European Commission have different legal weight : Regulation = Verordnung : text has to be implemented in national legislation as it stands Directive = Richtlinie : the principles have to be implemented in national legislation but leave the member states flexibility of interpretation and adaptation to national legislation Guidance = Leitfaden, Empfehlung 15/29 Mar 2011

34 THE EUROPEAN UNION (4) EudraLex, Volume 10: vol-10/ Chapter I: Application and application forms Chapter II: Monitoring and pharmacovigilance Chapter III: Quality of the IMP Chapter IV: Inspections Chapter V: Additional information Chapter VI: Legislation 16/29 Mar 2011 THE EUROPEAN UNION (5) EudraLex, Volume 10: Chapter I: Application and application forms CT-1: Detailed guidance for authorisation of a clinical trial and substantial amendment CT-2: Detailed guidance on the application format and documentation to be submitted to ethics committees CT-5: Detailed guidance on the EudraCT Database 17/29 Mar 2011 THE EUROPEAN UNION (6) EudraLex, Volume 10: Chapter II: Monitoring and pharmacovigilance CT-3: Detailed guidance on adverse reaction reporting (SUSARs) CT-4: Detailed guidance on the EudraVigilance Database Q&A specific to AR reporting ICH-E2F: Note for guidance on the development of safety update reports Note: there is NO guidance on monitoring of clinical trials!! 18/29 Mar 2011

35 THE EUROPEAN UNION (7) EudraLex, Volume 10: Chapter V: Additional Information ICH-E6: GCP guideline GCP guideline for advanced therapy medicinal products Recommendations on the content of the Trial Master File Ethical considerations for paediatric clinical trials Guideline on information to be made public from EudraCT 19/29 Mar 2011 THE EUROPEAN UNION (8) EudraLex, Volume 10: Chapter VI: Legislation Directive 2001/20/EC: Clinical Trials Directive Commission Directive 2005/28/EC: GCP Directive Commission Directive 2003/94/EC : GMP Directive 20/29 Mar 2011 DEUTSCHE GESETZGEBUNG (1) In Deutschland werden Gesetze zur klinischen Prüfung und Marktzulassung für Medikamente und Medizinprodukte vom Bundesministerium für Gesundheit erlassen Landesbehörden sorgen mit ihrer Überwachung für die Einhaltung der Gesetze Bundesinstitutionen sorgen für die Umsetzung der Gesetze 21/29 Mar 2011

36 DEUTSCHE GESETZGEBUNG (2) Deutschland hat zwei Institutionen für die Genehmigung von klinischen Prüfungen und die Marktzulassung für neue Medikamente Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) in Bonn Paul Ehrlich Institut in Langen bei Frankfurt 22/29 Mar 2011 DEUTSCHE GESETZGEBUNG (3) Arzneimittelgesetz (AMG) Medizinproduktegesetz (MPG) Verordnungen zu den Gesetzen Bekanntmachungen des BfArM 23/29 Mar 2011 DEUTSCHE GESETZGEBUNG (4) Deutsche Gesetzgebung für klinische Prüfungen 12. AMG-Novelle, am 06. August 2004 in Kraft getreten Ergänzungen in der 14. und 15. AMG-Novelle 4. MPG-Novelle, am 21. März 2010 in Kraft getreten GCP-Verordnung am 11. August 2004 in Kraft getreten Dritte Bekanntmachung des BfArM am 10. August 2006 veröffentlicht 24/29 Mar 2011

37 NOW In 2011, all clinical trials are expected to be conducted to ICH GCP standards. 25/29 Mar 2011 CONCLUSIONS (1) There are differences in different countries but harmonisation (ICH) is progressing. ICH Guideline for GCP is nowadays world standard. EU Directive 2001/20/EC ( Clinical Trials Directive ) and Directive 2005/28/EC ( GCP Directive ) have great impact. 26/29 Mar 2011 CONCLUSIONS (2) German clinical trials legislation has fully implemented the GCP guideline and the Clinical Trials Directive German clinical trial legislation consists of Arzneimittelgesetz, Medizinproduktegesetz, GCP-Verordnung and 3. Bekanntmachung des BfArM 27/29 Mar 2011

38 CONCLUSIONS (3) GCP contributes to better protection of study participants through Evaluation / approval of protocol by Research Ethics Committee Only participation after written consent of subject Surveillance of adverse events Protection of privacy of participants 28/29 Mar 2011 CONCLUSIONS (4) GCP contributes to better reproducible and more reliable data (less misconduct and/or fraud) through Strict compliance with Study Protocol Full documentation of all stages of the study (not documented = not done) Implementation of quality management system SOP s Training In-process quality control Audits by independent Quality Assurance Department Drug accountability Archiving 29/29 Mar 2011

39 Ethische Begutachtung und Ethikkommissionen

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41 ETHISCHE BEGUTACHTUNG UND ETHIKKOMMISSIONEN Dr. med. Ingrid Klingmann Pharmaplex bvba Brüssel, Belgien CONTENT Ethical aspects in clinical trials How to ensure an ethical randomised clinical trial? German Ethical Review Legislation 2/36 Jan 2011 ETHICAL REVIEW Ethics committees in Gemany review the scientific and ethical aspects of the clinical trial design as well as adherence to all GCP and national legal requirements The basis for their review is the Declaration of Helsinki, The Good Clinical Practice Guideline, the Arzneimittelgesetz and the GCP-Verordnung 3/36 Jan 2011

42 THE RANDOMISED CLINICAL TRIAL (1) The randomized clinical trial is the gold standard of clinical research (Meran, 1978) The randomized, double-blind, placebo-controlled trial is the gold standard for estimating drug treatment effects (Gilbert & Buncher, 2005) The double-blind, randomized, placebo-controlled clinical trial is considered the best method for collecting evidence about diagnostic, therapeutic, or preventive interventions. Well conducted placebo-controlled trials have high internal validity (Glass, 2008) 4/36 Jan 2011 THE RANDOMISED CLINICAL TRIAL (2)..but they lead to major ethical controversies: When is it ethical to randomise? Under which conditions is it ethical to randomise? Is randomisation in the patient s best interest? Does the methodological validity justify the disadvantages for the patients? Is randomisation a suitable method for all types of patients? Is placebo-control ethical? 5/36 Jan 2011 THE DECLARATION OF HELSINKI (1) It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfillment of this duty. A physician shall act in the patient's best interest when providing medical care In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests 6/36 Jan 2011

43 THE DECLARATION OF HELSINKI (2) It is the duty of physicians who participate in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation 7/36 Jan 2011 THE DECLARATION OF HELSINKI (3) Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefits or when there is conclusive proof of positive and beneficial results. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects 8/36 Jan 2011 THE DECLARATION OF HELSINKI (4) In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest... After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject s freely-given informed consent, preferably in writing 9/36 Jan 2011

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