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