ich gcp
DESCRIPTION
A very good detailed presentation on ICH GCP.TRANSCRIPT
What is ICH?
ICH is a joint initiative involving both the regulators and the industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of medicines.
How did it evolve?
The need to harmonize Public disasters, serious fraud and
abuse of human rights. Trials of War criminals-Nuremberg
code 1949 Thalidomide- Declaration of Helsinki
1964 Belmont report 1978( Ethical Principles and
guidelines for the protection of human subjects of research)-Tuskegee syphilis study
History
1962 US FDA IND Guidelines
1964 Declaration of Helsinki
1968 Committee on Safety of Medicines, uk
1978 GCP, US FDA
1991 GCP, Europe
1996 ICH GCP
1997 ICH GCP Guideline
When did it begin?
Ist conf. in 1990 in Brussels
3 regions participated
Representatives from
Industry
Academia
Ministry of health
ICH parties
6 parties EU EFPIA European federation of pharmaceutical industries’
associations
MHLW Ministry of health, Labor and welfare, Japan
JPMA Japan Pharmaceuticals manufacturers Association
US FDA PhRMA Observers : WHO, TPP(canada) International federation of Pharmaceutical
manufacturer’s association
Key objective
To discuss and define the minimum standards for the development and registration of investigational products
The result?
Many guidelines made
Most important- ICH GCP guidelines Evolved in several steps Consolidated guideline ICH E6 Sept
1997
ICH Guidelines: examples
Efficacy: clinical trials etc
Safety: pharmacovigilance, adverse drug reaction
reporting Quality:
raw materials, impurities, residual solvents etc Multidisciplinary:
common technical document, electronic submission, coding systems
The ICH Story
Who: Regulatory authorities and research-based industry of the EU, US and Japan; WHO, EFTA and Canada observers
Why: Reduce unnecessary duplication and thereby contribute to the efficiency of drug development and registration for new pharmaceuticals
How: Through the development of science-based, international guidelines and standards
What is GCP?
A standard for the design, conduct, performance, monitoring ,auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible, accurate and that the rights, integrity and confidentiality of trial subjects are protected.
Why is it needed?
To ensure the rights, safety and well being of the trial subjects are protected
Ensure the credibility of clinical trial data
The ICH GCP guideline
Provide a unified standard for the EU, Japan and USA regions to facilitate mutual acceptance of clinical trial data
by the regulatory authorities in these regions.
?The need No acceptance of foreign clinical data Regional variation in reg guidelines Escalating costs Extended time for registration ICH region covers 85% of Pharm. sales
ICH GCP guideline
8 sections
ICH GCP guideline
1. Glossary
Common language for investigators/sponsors/ethics committees
2.Principles of Good Clinical Practice
13 tenets of ICH GCP
3.Requirements for IRB/IEC
Roles responsibilities and composition
ICH GCP guideline
4.Responsibilities of the investigator
5.Responsibilities of the sponsor
6.Requirements for clinical trial protocol and protocol amendments
7.Responsibility of the sponsor in the development of investigator’s brochure.
8.Essential documents
Principles of ICH GCP
Ethical conduct as per Declaration of Helsinki GCP Regulatory Requirements Risk- Benefit Primary concern- Subject
Principles of ICH GCP Supportive data
Protocol Scientifically sound, clear, detailed
Ethical Clearance Study to be conducted in compliance
to the protocol which has received EC approval
Principles of ICH GCP
Subject Care Medical decisions responsibility of
qualified physician Qualified staff By education, training, experience in
their area of responsibility Informed Consent
Principles of ICH GCP
Clinical Trial data Recorded, handled and stored to
enable accurate reporting, interpretation and verification
Confidentiality
Principles of ICH GCP
Investigational Product Manufactured, handled and stored as
per GMP
Used as per the protocol
Principles of ICH GCP
Quality Assurance
Systems and procedures to ensure the Quality of every aspect of the trial
Concerns about ICH
Industry driven agenda or public health oriented approach
Public health implications- inability to achieve standards and withdrawal of essential drugs
Misdirecting national priorities
ICH vs. non-ICH
ICH: 17 countries 15% world population 82% drug production 90% drug sales 95% R&D New Chemical Entities Chronic & lifestyle
diseases Strong DRAs $$$$$
“non-ICH”: 176 countries 85% world population 18% drug production 10% drug sales 5% R&D Mainly generics Life-threatening diseases
Weak DRAs $
Indian GCP guidelines
Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)
In general, in line with ICH GCP
Has Revised Schedule Y (Jan 2005) addressed discrepancies?
Issues in Developing Countries
The informed consent process Economic Vulnerability Patient doctor relationship Education level
ROLE OF GCP ?ROLE OF GCP ?
Good clinical practice (gcp) is an international ethical & scientific standard for conducting clinical trials that involve the participation of human subjects
Compliance with this standard provides public assurance that the rights, safety & well-being of trial subjects are protected, which is consistent with the principles outlined in the declaration of helsinki
GCP also ensures the credibility of clinical trial data.
INTERNATIONAL ETHICAL INTERNATIONAL ETHICAL STANDARDSSTANDARDS
Professional standards for the protection of human subjects in
research did not exist till late 1940’s.
Nuremberg tribunal held in 1945 and 1946 that “voluntary
consent of the human subject is absolutely essential”
The Declaration of Helsinki outlines 12 principles by which
physicians must conduct research in therapeutic & non-
therapeutic interventions.
Fundamental Ethical Principles Guiding Protection Of Human Subjects In Biomedical ResearchFundamental Ethical Principles Guiding Protection Of Human Subjects In Biomedical Research
RESPECT FOR PERSONS: Acknowledges the dignity & autonomy of individuals. This principle requires that subjects give their informed consent prior to participating in research.
BENEFICENCE: Obligates researchers to treat subjects fairly.
• JUSTICEJUSTICE: requires the equitable : requires the equitable selection of subjects in light of selection of subjects in light of research setting & research research setting & research purposes.purposes.
PRINCIPLES BEHIND GCPPRINCIPLES BEHIND GCP
Before initiating any clinical trial, ANTICIPATED RISKS should be weighed against EXPECTED BENEFITS for the trial subject & society
• The RIGHTS, SAFETY & WELL BEING of trial subjects The RIGHTS, SAFETY & WELL BEING of trial subjects are the most important considerations & should prevail are the most important considerations & should prevail over the interests of science & society.over the interests of science & society.
• The entire study procedure should be The entire study procedure should be scientifically sound & detailed in a trial scientifically sound & detailed in a trial protocol. This protocol should receive a protocol. This protocol should receive a prior APPROVAL FROM AN prior APPROVAL FROM AN INDEPENDENT ETHICS COMMITTEE.INDEPENDENT ETHICS COMMITTEE.
ETHICAL REVIEW SHOULD DEFINE JUSTIFIABLE BOUNDARIES BETWEEN THE RIGHTS OF THE SUBJECT AND THE BENEFITS THAT MIGHT ACCRUE TO SOCIETY THROUGH SCIENTIFIC INFORMATION DEVELOPED IN
CLINICAL TRIALS.
Regulations have been established internationally, to ensure ethical & scientific conduct of trials
Regulations have been established internationally, to ensure ethical & scientific conduct of trials
GOALS OF INTERNATIONAL HARMONIZATION OF REGULATORY REQUIREMENTS
GOALS OF INTERNATIONAL HARMONIZATION OF REGULATORY REQUIREMENTS
SAFEGUARD PUBLIC HEALTH ASSURE CONSUMER PROTECTION STANDARDS FACILITATE AVAILABILITY OF SAFE AND
EFFECTIVE PRODUCTS ELIMINATE INCONSISTENT STANDARDS
INTERNATIONALLY FACILITATE MUTUAL ACCEPTANCE OF DATA
FROM CLINICAL TRIALS
STAKEHOLDERS & THEIR RELATIONSHIPS
SUBJECTSUBJECT
REGULATORY REGULATORY AUTHORITYAUTHORITY
SPONSORSPONSORETHICSETHICS
COMMITTEECOMMITTEEINVESTIGATOR
ROLE OF ETHICS COMMITTEESROLE OF ETHICS COMMITTEES
Play a vital role in protecting human subjects in clinical trials.
They review trial protocols to ensure that…. informed consents are obtained from the subjects subjects are not exposed to unreasonable risks
Establishment of EC’s has become a cornerstone of protection of human subjects in clinical research
Protection of Human SubjectsPrior To Study Start
The investigator must request ethics approval for: Protocol Informed Consent Form/Advertisements/Other
Information Protocol amendment and /or Informed Consent
Amendments All sites at which patient activity will occur
Protection of Human Subjects During the study
The investigator must request ethics approval for any change in the research activity
The investigator must submit progress reports to the IRB as required
The subject must be informed of any new information which might affect their decision to continue participation in the trial
RESPONSIBILITIES OF THE INVESTIGATORRESPONSIBILITIES OF THE INVESTIGATOR
Conduct the research in accordance with the protocol and Good Clinical Practice (GCP)
Protect the rights, safety, and welfare Protect the rights, safety, and welfare of the subjectsof the subjects
Report all adverse events (serious Report all adverse events (serious and non-serious)and non-serious)
Retain study documents and Retain study documents and medical recordsmedical records
Control the distribution and use of Control the distribution and use of the study medicationthe study medication
RESPONSIBILITIES OF THE SPONSORRESPONSIBILITIES OF THE SPONSOR The sponsor is responsible for
implementing and maintaining quality assurance of data generated in compliance with the protocol
Sponsor is responsible for securing agreement from all involved parties to ensure direct access to all sites, source data & reports for the purpose of monitoring & auditing by regulatory authorities
Agreements made by the sponsor with the investigator should be in writing
MEDICAL CARE OF TRIAL SUBJECTSMEDICAL CARE OF TRIAL SUBJECTS
During and following a subject’s participation in a trial, the investigator & institution should ensure that adequate medical care is provided to deal with adverse events related to the trial
The investigator should inform the subject’s primary physician about the trial & the subject’s participation
Protection of Human SubjectsInformed Consent
Must be signed and dated by the subject prior to study start
Language understandable to the subject Subject Information Sheet approved by the
Ethics Committee The Consent Form must contain the
elements required by GCP Subject must be given a copy
Study DocumentationBefore the study starts
IRB approval letter Members of IRB and their
qualifications/affiliation Normal ranges of clinical laboratory
Study DocumentationDuring the study
The investigator must keep: Source documents
Medical records (including access to computer records)
Laboratory reports ECGs, X-rays, etc. Any other medical records, reports or notes
(hospital admissions and discharges) A subject identification list Copies of all study related documentation
Medical Records
In particular, they should contain notes on: Sufficient information to support subject eligibility This should be well documented (signed and dated) Subject’s participation in the study Dates of visits Procedures, investigations done Observations, diagnoses Medications taken (including study medication) Adverse events / SAE’s Completion or withdrawal (reason) from the study
Study DocumentationAfter the study
The sponsor needs from the investigator:
Final drug accountability records All used and unused supplies and medication All required documents completed
The trial subjects should be explained the correct use of the investigational product and compliance to these instructions should be checked periodically
Investigator should maintain records of the delivery of the product, the inventory, use by each subject as per protocol
INVESTIGATIONAL INVESTIGATIONAL PRODUCTPRODUCT
MONITORINGMONITORING
The rights & well-being of human subjects are protected
The reported data are accurate, complete & verifiable from source documents
The conduct of the trial is in compliance with approved protocol & with applicable regulatory requirements
• THE PURPOSES OF MONITORING ARE TO THE PURPOSES OF MONITORING ARE TO VERIFY THAT…VERIFY THAT…
Questions?
