S1 KAVANA BB MBAT-Goos clinical Pratice.pptx

S1 KAVANA BB MBAT-Goos clinical Pratice.pptx

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  KARNATAKA COLLEGE OFPHARMACY SUBJECT : MODERN BIOANALYTICAL TECHNIQUES SEMINAR ON TOPIC: GOOD CLINICAL PRACTICES PRESENTED TO: Dr. Harsha K Tripathy Department of pharmaceutical analysis KCP PRESENTED BY: KAVANA BB ( M pharma II SEM ) Department of pharmaceutical analysis KCP KARNATAKA COLLEGE OF PHARMACY 1
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  CONTENTS : • INTRODUCTION •HISTORY OF GCP • Principle of ICH-GCP • Guidelines for GCP KARNATAKA COLLEGE OF PHARMACY 2
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  GOOD CLINICAL PRACTICES •An international set of guidelines that helps make sure that the results of a clinical trial are reliable and that the patients are protected. • Good Clinical Practice covers the way a clinical trial is designed, conducted, performed, monitored, audited, recorded, analyzed, and reported. Also called GCP. • GCP follows the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. KARNATAKA COLLEGE OF PHARMACY 3
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  PURPOSE • GCP aimsto ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. • GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. • It also provides assurance of the safety and efficacy of the newly developed compounds. KARNATAKA COLLEGE OF PHARMACY 4
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  History of GCP 460BCOath of Hippocrates 1930's U.S. Food, Drugs and Cosmetic Act 1947 Nuremberg Code Dec. 10th 1948 Declaration of Human Rights 1962 Kefauver-Harris Amendment 1964, revised 2000 Declaration of Helsinki 1979 The Belmont Report 1982 International Guidelines for Biomedical Research Involving Human Subjects 1996 ICH-GCP guidelines issued 1997 ICH-GCP guidelines becomes law in some countries KARNATAKA COLLEGE OF PHARMACY 5
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  • In 1947,the Nuremberg Code was created as a result of the unethical and horrific experiments carried out during World War II at Nazi war camps by German physicians, who were subsequently tried and charged at the Nuremberg Military Tribunal. • This code states the need for a scientific basis in research on human subjects and voluntary consent and protection of participants . The Universal Declaration of Human Rights (December 10th 1948) was also adopted and proclaimed by the United Nations after the atrocities of World War II and it further reiterated the human factor involved in medical experiments. KARNATAKA COLLEGE OF PHARMACY 6
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  • In 1962the world was once again shocked by the severe fetal limb deformities linked to the use of maternal thalidomide. In fact this drug reaction was only discovered after 10,000 infants were born in over 20 countries worldwide. In response to this, the Kefauver-Harris Amendments were passed which required the FDA to evaluate all new drugs for safety and efficacy. • In 1964, the Declaration of Helsinki was developed by the World Medical Association, forming the basis for the ethical principles that underlie the ICH-GCP guidelines we have today. The focus of this declaration is the protection of the rights of human subjects and this is clear in its introduction: “The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty” KARNATAKA COLLEGE OF PHARMACY 7
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  • Another importantmilestone in the formation of the ICH-GCP guidelines was The Belmont Report which was issued in April 1979 by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research . The principles of this report are as follows: 1.Respect for Persons: This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from research subjects (or their legally authorized representatives) 2.Beneficence: This principle requires that researchers maximise benefits and minimize harms associated with research. Research-related risks must be reasonable in light of the expected benefits. 3.Justice: This principle requires equitable selection and recruitment and fair treatment of research subjects. KARNATAKA COLLEGE OF PHARMACY 8
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  • In 1982,the World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) issued a document entitled ‘International Guidelines for Biomedical Research Involving Human Subjects‘. • This document was released to help developing countries apply the principles of the Declaration of Helsinki and the Nuremberg Code . Worldwide, many organizations and committees issued various documents and guidelines on the same issue, and a decision was taken to consolidate all these guidelines into one universal guideline to be used globally. KARNATAKA COLLEGE OF PHARMACY 9
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  • In aneffort to overcome international GCP inconsistencies throughout the countries, the International Conference for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued the ICH Guidelines: Topic E6 Guideline for GCP. • This guideline was approved on 17 July 1996 and implemented for clinical trials from 17 January 1997. The participants of these guidelines were representatives of authorities and pharmaceutical companies from the EU, Japan and the United States as well as those of Australia, Canada, the Nordic countries and WHO • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097692/ KARNATAKA COLLEGE OF PHARMACY 10
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  PRINCIPLE OF ICH-GCP Goodclinical practice guidelines include 13 principles that apply to all clinical research that can affect the safety and well-being of human participants. The thirteen good clinical practice guidelines can be considered in these categories: • Ethics • Protocols and science • Responsibilities • Informed consent • Data quality and integrity KARNATAKA COLLEGE OF PHARMACY 11
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  • Ethics 1. Ethicalconduct of clinical trials Clinical trials should be conducted in accordance with good clinical practice guidelines and the applicable regulatory requirement(s). 2. Benefits justify risks Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society at large. 3. Rights, safety, and well-being of subjects prevail The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. KARNATAKA COLLEGE OF PHARMACY 12
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  • Protocol andscience 4. Non-clinical and clinical information supports the trial The available non-clinical and clinical information regarding the safety of an investigational product should be adequate to support proceeding with a proposed clinical trial. 5. Quality trials based on comprehensive protocols Clinical trials should be scientifically sound and described in a clear, detailed protocol. • Responsibilities 6. IRB/IEC approval and compliance with the study protocol A trial should be conducted in compliance with a study protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval. KARNATAKA COLLEGE OF PHARMACY 13
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  7. Medical careand health-related decisions by a qualified physician 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. 8. Trial staff has appropriate qualifications Each individual involved in conducting a trial should be qualified by education, training, and experience to perform their respective task(s). • Informed consent 9. Consent based on decision capacity, documentation of consent, disclosure, and competency Freely given informed consent should be obtained from every subject prior to clinical trial participation. KARNATAKA COLLEGE OF PHARMACY 14
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  • Data Qualityand integrity 10. Accurate reporting, interpretation, and verification of clinical data All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification. 11. Protection of personally identifiable information (PII) and other sensitive information The confidentiality of records that could identify subjects should be protected to adhere to privacy and confidentiality rules in accordance with good clinical practice guidelines. 12. Good Manufacturing Practice followed Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice guidelines. They should also only be used in accordance with the approved protocol. 13. Quality assurance embedded into study Systems with procedures must be in place to assure the quality of every aspect of the trial. KARNATAKA COLLEGE OF PHARMACY 15
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  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 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 KARNATAKA COLLEGE OF PHARMACY 16
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  GCP PARTICIPANTS Regulatory Authorities Reviewsubmitted clinical data and conduct inspections The sponsor Company or institution/organization which takes responsibility for initiation, management and financing of clinical trial The project monitor Usually appointed by sponsor The investigator Responsible for conduct of clinical trial at the trial site. Team leader. The pharmacist at trial location Responsible for maintenance, storage and dispensing of investigational products eg. Drugs in clinical trials Patients Human subjects Ethical review board or Committee for protection of subjects Appointed by Institution or if not available then the Authoritative Health Body in that Country will be responsible Committee to monitor large trials Overseas Sponsors eg. Drug Companies KARNATAKA COLLEGE OF PHARMACY 17
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  THANK YOU KARNATAKA COLLEGEOF PHARMACY 18