ICH GCP
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The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline. ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
ICH GCP
- 1. ICH-GCP Tamer Hifnawy. MD. Dr (PH) Associate Professor of Public health Faculty of Medicine, Beni Suef University, Egypt College of Dentistry, Taibah University, KSA Acting Vice Dean for Quality and Development Certified Trainer in International Research Ethics
- 2. Research is a systematic investigation designed to discover or contribute to a body of generalisable knowledge. What is research?
- 3. It is important at this point to draw the line between “research” and “practice”.
- 10. GCP, Our Story
- 11. Good Clinical Practice An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Clinical Data are credible.= the Rights, Safety and well-being of Trial Subjects are Protected= Quality Data Ethics Quality Data + Ethics = GCP
- 12. Can GCP be trained? Knowledge transfer through Involvement ICH GCP Benjamin Franklin: Father of the Bifocal
- 13. GCP involve from first to last Clinical Trial process is like building a bridge We can’t afford to deviate from ICH-GCP
- 15. Course 4 Introduction to ICH-GCP Slide no 15 30 Jan 201 0 What is GCP?
- 16. ICH GCP The History & Development 1536 Ambroise Paré , Wound healing 1747 James Lind , Scurvy treatment ( Perhaps the first ever clinical trial was James Lin’s demonstration that citrus fruits cure scurvy .He compared the effects of various different acidic substances, ranging from vinegar to cider, on groups of afflicted sailors, and found that the group who were given oranges and lemons had largely recovered from scurvy after 6 days.) 1894 Placebo control 1931 Flip of a coin randomisation
- 17. ICH GCP The History & Development The Disasters 1937 100 patients died, due to diethylene in sulpha preparation 1950 Aplastic anaemia on Chloramphenicol 1961 Softenon (thalidomide) catastrophe in Europe March 2006 The drug TGN1412 caused catastrophic systemic failures in the subjects during its first human clinical trials (phase I). Following this, an Expert Group on Phase in One Clinical Trials published a report.
- 18. ICH – GCP : Evolution 1980s - EC ◦ Pioneered harmonization of regulatory requirements ◦ Develop single market for medicinal products ◦ Demonstrated feasibility of harmonization 1989, Paris - WHO Conference of Drug Regulatory Authorities ◦ IFPMA – discuss joint regulatory-industry initiative ◦ ICH conceived Apr, 1990, Brussels – EFPIA ◦ Birth of ICH ◦ ICH Steering Committee established
- 19. Need to Harmonize Awareness on critical evaluation of medicinal products Medical tragedies 1960-70: rapid increase in laws, regulations & guidelines on medicinal products Widening market opportunities for Pharma industry Duplication of work Raising cost of health care Timely Access of Patients to Safe & Effective “New Drugs” Need to meet public expectation
- 20. ICH GCP 1990/91 Guidelines on GCP in Europe 1996 ICH GCP conference 1997 All clinical trials in Europe must comply to the ICH /GCP guidelines
- 21. The Objectives of ICH GCP Main goals Protect the patient To provide a unified standard for the European Union (EU), Japan & United States to facilitate mutual acceptance of clinical data by the authorities in these jurisdictions Facilitate the mutual acceptance of clinical data across ICH GCP regions Avoid trial duplication (saving time, money, resource) Facilitate global submissions through mutual acceptance of data Technical requirements for medicinal products containing new drugs
- 22. ICH- GCP
- 23. ICH Born April 1990 Brussels meeting European Federation of Pharmaceutical Industries Association (EFPIA) Representatives of regulatory agencies and industry form EU, Japan, and USA
- 24. ICH – Aim The International Conference on Harmonization (ICH) is a joint initiative involving both regulators and industry in the scientific and technical discussions of procedures which are required to ensure and assess the safety, quality and efficacy of medicines. The focus of ICH has been on the technical requirements for medicinal products containing new drugs. Scope on registrations in the 3 regions. One single Marketing Authorisation Application worldwide.
- 25. What and Who does GCP apply to? GCP applies to clinical trials in humans for drugs, biologicals and devices GCP applies to every one and anyone involved in the conduct of a clinical trial - Sponsors - Research site staff - IRB/ ethics committees - CROs - Patients
- 26. Structure of ICH - Parties Participants Six Parties: EU, EFPIA, FDA,MHLW, JPMA, PhRMA Three Observers: WHO, EFTA “European Free Trade Association”, Canada European Commission - European Union (EU) European Federation of Pharmaceutical Industries and Associations (EFPIA) US Food and Drug Administration (FDA) Ministry of Health, Labor and Welfare, Japan (MHLW) Japan Pharmaceutical Manufacturers Association (JPMA) Pharmaceutical Research and Manufacturers of America (PhRMA)
- 27. Definition of GCP (Good Clinical Practice) Definition of ICH-GCP “ICH GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects . Compliance with this standard provides public assurance that the rights , safety and well being of the 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” A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurances that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. ”
- 28. Declaration of Helsinki - 1964 Developed to guide physicians in biochemical research involving human subjects Requires: All physicians to conform to accepted scientific principles A research protocol to be reviewed by an independent committee Research performed by “clinically competent person” Objective proportional to risk Rights of patients protected Participants to be fully informed, and to consent to take part
- 30. Copyright 2007 ACRP 30 E6: Good Clinical Practice Guideline is one of the major achievements of ICH Led to regulatory changes in the 3 regions
- 31. Principals of ICH GCP Before the trial is initiated ◦ Risk Vs. Benefit ◦ Right; Safety and well being of trial subjects ◦ Clear and scientific protocol ◦ Trials should have REC approval ◦ Medical care is the responsibility of a qualified Physician. ◦ Research Physicians should be qualified
- 32. Principals of ICH GCP During the trial ◦ Patients should freely give their Consent ◦ Appropriate and careful recording and storage of trial information. ◦ Confidentiality ◦ GMP ◦ Applicable Systems and procedures
- 33. 30 Jan 2010 13 Principles of GCP
- 35. 13 Principles of GCP ( A set of standard principles for the initiation and conduct of clinical trials) Clinical trials should be conducted in accordance with ethical principles and applicable regulatory requirements Risk versus benefits should be assessed Rights, Safety and the well being of the trial subjects are the most important considerations Preclinical and clinical information on an investigational product should support the proposed clinical trial Clinical trials should be scientifically sound and described in a clearly detailed protocol
- 36. 13 Principles of GCP ( A set of standard principles for the initiation and conduct of clinical trials) A trial should be conducted in compliance with the approved protocol Qualified Physician Is Responsible for medical care and medical decisions made on behalf of subjects Each individual involved in conducting a clinical trial should be qualified by education, training, and experience to perform his/her respective tasks Freely given, informed consent should be obtained from every subject prior to clinical trial participation All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification
- 37. 13 Principles of GCP ( A set of standard principles for the initiation and conduct of clinical trials) Confidentiality of records that could identify subjects should be protected Investigational products should be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practices Systems and procedures that ensure the quality of every aspect of the trial should be implemented, which is generally the responsibility of the sponsor
- 38. Efficacy Guidelines (Important guidelines) E 1: Exposure – to assess clinical safety E 2: Clinical Safety Data Management E 3: Study Reports E 6: Good Clinical Practice (GCP) E 8: Clinical Trials Design
- 39. Present as well as future It is the protection for today and tomorrow
- 40. Essence of ICH-GCP guideline in Clinical Trial What will happen if trial is not conducted with ICH-GCP guideline?
- 41. 5/12/2014 Prof. Maha Hegazi, Alex. Univeristy 41