Good Clinical Practice

  • View
    1.333

  • Download
    0

Embed Size (px)

Transcript

Principle of Good Clinical Practice

Good Clinical PracticeDr. Venkata Subba Reddy AMBBS;MD(Pharmacology)Founder & Chief Editorwww.thepharmacology.com

At the end of this presentation you should be able to know..Define GCP Outline the principles of GCPThe players involved in GCPShould follow GCP

What is GCPA standard for designing, conducting, recording and reporting of studies involving human subjects.Public assurance that the rights, safety and well-being of trial subjects are protected.

Research regulatoryNot regulatedGLPGCPGMP

History ofHUMAN RESEARCH & REGULATIONS

Nuremberg CodeDecember 9, 1946 - American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for crimes against humanity 16 found guiltyGerman Physicians conducted medical experiments on thousands of camp prisoners without their consent. Most of the participants of these experiments died or were permanently crippled.The Nuremberg Code was established in 1948, stating that "The voluntary consent of the human participant is absolutely essential," It did not carry the force of law, but the Nuremberg Code was the first international document which advocated voluntary participation and informed consent.

Kefauver Amendments1960s Thalidomide as anti emetic in pregnancy used in Europe (but not approved by US FDA)Deformities in foetusNo informed consent (not approved by FDA)1962 US Senate hearings Kefauver Amendments passed into law - For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them

Declaration of Helsinki World Medical Association - recommendations guiding medical doctors in biomedical research involving human participantsResearch with humans should be based on the results from animal and laboratory experimentation.Research protocols should be reviewed by an independent committee prior to initiationInformed consent from research participants is necessaryResearch should be conducted by medically/scientifically qualified individualsRisks should not exceed benefitsRevised - 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008

Tuskegee Syphilis StudyStudy on 600 low income African-American by U.S. Public Health ServiceFree medical examination but not told of diagnosisMany died of syphilisStopped in 1973 by the U.S. Department of Health, Education, and Welfare1974 National Research Act passed - National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research establishedThe commission produce Belmont Report (1979)

Belmont ReportThree basic ethical principalsAutonomy/respect for persons (Individuals should be treated as autonomous agents & Persons with diminished autonomy are entitled to protection)Beneficence (Human participants should not be harmed & Research should maximize possible benefits and minimize possible risks) and Justice (benefits and risks of research must be distributed fairly)which are the cornerstone for regulations involving human participants.

Evolution of GCP1930s US Food Drug & Cosmetic Act1947 Nuremberg Code1962 - Kefauver Amendments (US) (following Thalidomide tragedy)1964 Declaration of Helsinki1974 National Research Act (US)1979 - Belmont Report (US)1986 England ABPI Guideline1987 - France - Bonnes Pratiques Clinique1989 Scandinavia - Nordic Guidelines , Good Clinical Trial Practice1990 France Huriet Law1990 - EC - Good Clinical Practice for Trials on Medicinal Products in the European Community1992 - WHO Guidelines, Australian Guidelines1997 ICH GCP became law in some countries1999 - Malaysian GCP

12

A comprehensive representation of the development of GCP can be found in a literature review of ..

What is ICH?International Conference on HarmonisationRealisation to have independent evaluation of medical products mostly driven by tragedy1960-1970s - rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy Varied from country to country need to harmonisePioneered by European Community (EC) (now the European Union) in 1980sWHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989ICH was initiated on April 1990, in a meeting hosted by EFPIA (European Federation of Pharmaceutical Industries and Associations) in BrusselsMain outcome - Tripartite ICH Guidelines on Safety, Quality and Efficacy

Aims of ICHUnify registration requirements for new productsReduce medicinal product development costs: more economical use of animal, human and material resources.Accelerate medicinal product licensing times: avoid repeat testing in different regions.Increases patent protection times through reducing delay in licensing times.

ICH represents17 countries comprising 15% of the worlds population 90% of the US$ 320 billion global pharmaceutical sales of the year 2000

PrincipleS of ICH GCP

The summary of the principles...!!!Conduct trials according to GCPWeigh risks vs. benefitsSubjects wellbeing exceed the scienceHave adequate information to justify trialWrite a sound protocolReceive IRB/IEC approvalUse qualified physiciansUse qualified & trained support staffObtain informed consentRecord information appropriatelyConfidentiality & data protectionHandle investigational products appropriatelyQuality assurance

Principles of ICH GCPClinical 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).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.The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

Principles of ICH GCP.The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.Clinical trials should be scientifically sound, and described in a clear, detailed protocol.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.Clinical trials should be scientifically sound, and described in a clear, detailed protocol

Principles of ICH GCP.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.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.Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).Freely given informed consent should be obtained from every subject prior to clinical trial participation.

Principles of ICH GCP.All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verificationThe confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).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.Systems with procedures that assure the quality of every aspect of the trial should be implemented.

The summary of the principles...!!!Conduct trials according to GCPWeigh risks vs. benefitsSubjects wellbeing exceed the scienceHave adequate information to justify trialWrite a sound protocolReceive IRB/IEC approvalUse qualified physiciansUse qualified & trained support staffObtain informed consentRecord information appropriatelyConfidentiality & data protectionHandle investigational products appropriatelyQuality assurance

The PlayersInstitutional Review Board/ Ethics committeeThe InvestigatorThe SponsorThe Monitor

Institutional Review Board/ Ethics committeeAn IRB/IEC should safeguard the rights, safety, and well being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjectsThe IRB/IEC should obtain the following documentsTrial protocol(s)/ Amendment(s)Written informed consent form(s)Subject recruitment proceduresWritten information to subjectsInvestigator`s brochure(IB)Available safety informationInformation about payments and compensation available to subjectsThe investigator`s current curriculum vitaeUndertaking by investigatorBio Equivalence No Objection Certificate

Institutional Review Board/ Ethics committeeThe IRB/IEC should review a proposed clinical trial within a reasonable timeThe IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least one per yearAdequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trialsThe IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problem of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject

Investigator The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualif