Post on 07-May-2015
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ICH-GCPTamer Hifnawy. MD. Dr (PH)
Associate Professor of Public healthFaculty of Medicine, Beni Suef University, Egypt
College of Dentistry, Taibah University, KSAActing Vice Dean for Quality and Development
Certified Trainer in International Research Ethics
Research is a systematic investigation designed to discover or contribute to a body of generalisable knowledge.
What is research?
It is important at this point to draw the line between “research” and
“practice”.
The GCP Story
ONE WEEK LATER
The Brilliant Idea
GCP
Good Cooking
Practice
GCP
GCP, Our Story
Good Clinical PracticeAn 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
Can GCP be trained? Knowledge transfer through Involvement
ICH GCP
Benjamin Franklin: Father of the Bifocal
GCP involve from first to last
Clinical Trial process is like
building a bridge We can’t afford to
deviate from ICH-GCP
Design
Conduct
Performance
Monitoring
Auditing
Analysis
Reporting
What does GCP Cover?
Course 4 Introduction to ICH-GCP Slide no 15
30 Jan 2010
What is GCP?
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
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.
ICH – GCP : Evolution1980s - 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
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
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
The Objectives of ICH GCPMain 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
ICH- GCP
Copyright 2007 ACRP 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
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.
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
Structure of ICH - PartiesParticipants
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)
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. ”
Declaration of Helsinki - 1964Developed 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
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
Principals of ICH GCPBefore 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
Principals of ICH GCPDuring the trial
◦Patients should freely give their Consent
◦Appropriate and careful recording and storage of trial information.
◦Confidentiality◦GMP◦Applicable Systems and procedures
30 Jan 201013 Principles of GCP
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
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
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
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
Present as well as future
It is the protection for today and tomorrow
Essence of ICH-GCP guideline in Clinical Trial
What will happen if trial is not conducted with ICH-GCP guideline?
04/11/2023 Prof. Maha Hegazi, Alex. Univeristy 41