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Good clinical practices(GCP)

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Good Clinical Practices for drug discovery and development

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Good clinical practices(GCP)

  1. 1. Good Clinical Practices Dr. Fardan Qadeer JR I, Department of Pharmacology Moderator: Dr. Ali Ahmad Head Dept. of Pharmacology
  2. 2. Basic Research Disease Recovery Drug Recovery Preclinical Development Clinical Trials Manufacturing Not regulated GLP GCP GMP
  3. 3. Drug discovery and development PRE CLINICAL TRIAL CLINICAL TRIAL HUMANS Adverse Effect Ethical issues Drug Toxicity
  4. 4. Phase I • Checking for safety • 10-20 healthy volunteers • Unexpected side effects may occurs Phase II • Checking for efficacy • ~ 200 samples • How good is the intervention • If not good, normally detect here Phase III • Checking effectiveness • ~ 1000s samples • Looking for rare side effect Phase IV • Test long term safety • Real patients • Involve untested group of people
  5. 5. Good Clinical Practices (GCP) is an international ethical & scientific quality standard for designing, conducting, recording & reporting trials that involve the participation of human subjects. It ensures the RIGHTS SAFETY WELL BEING Designing Clinical Trials or Studies Conducting Monitoring Recording Reporting Analysis
  6. 6. HISTORICAL BACKGROUND Nuremberg Code, 1946 Kefauver Amendments, 1962 – Thalidomide Declaration of Helsinki, 1964 National Research Act, 1974 - Tuskegee Syphilis Study (1932-1972) Belmont Report, 1979
  7. 7. Nuremberg Code:1946 German Physicians conducted medical experiments on prisoners of war without their consent in during the time of Nazi rule. Most of the participants of these experiments died or were permanently crippled.
  8. 8. • In December 9, 1946 - American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for crimes against humanity – 16 of them were found guilty • 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.
  9. 9. Kefauver Amendments-1960 • Thalidomide was as a sedative during pregnancy in Europe but was not approved by US FDA • This lead to deformities in foetus • 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
  10. 10. Declaration of Helsinki-1964 • World Medical Association - recommendations guiding medical doctors in biomedical research involving human participants 1. Research with humans should be based on the results from laboratory and animal experimentation 2. Research protocols should be reviewed by an independent committee prior to initiation 3. Informed consent from research participants is necessary 4. Research should be conducted by medically/scientifically qualified individuals 5. Risks should not exceed benefits • Revised - 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008
  11. 11. Tuskegee Syphilis Study- 1932 to 1972 • The US Public Health Services conducted a Syphilis Study on 600 low income African-American individuals • During this study many people died of syphilis • Stopped in 1973 by the U.S. Department of Health, Education, and Welfare • 1974 National Research Act passed - National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research established • The commission produce Belmont Report (1979)
  12. 12. Belmont Report-1979 National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research
  13. 13. Key points: • To make sure the study is approved by an IRB • Get informed consent from the patient • Be sure that the patient understands the full extent to the experiment, and if not contact the study coordinator • Make sure the patient wasn't coerced into doing the experiment by means of threatening or bullying • Be careful of other effects of the clinical trial that was not mentioned, and report it to the proper study coordinator • Support the privacy of the patients identity, their motivation to join or refuse the experiment. • Ensure all patients get at the least, minimal care needed
  14. 14. ICH • The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a joint initiative the experts in pharmaceutical industry of Europe, Japan and the United States to discuss scientific and technical aspects of pharmaceutical product registration. • 1980s-The European Union began harmonising regulatory requirements. • 1989- Europe, Japan, and the United States began creating plans for harmonisation; • 1990-ICH was created in April 1990 at a meeting in Brussels
  15. 15. Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health. Co sponsors Observers Non voting member coordinates its technical input to ICH through its Scientific and Regulatory Section Steering Committee
  16. 16. Drug Regulatory authority of India is also invited in ICH bi-annual meetings. • DRH representatives participate in the Global Cooperation session of the ICH Steering Committee (SC) to discuss capacity-building and share experience/challenges on the implementation of ICH Guidelines. • Representatives also listen to ICH technical topics discussed by the SC during meetings and are invited to nominate technical experts in Expert Working Groups/Implementation Working Groups to contribute to the development of ICH Guidelines.
  17. 17. Principles of ICH GCP • 2.1 Clinical 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). • 2.2 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.
  18. 18. • 2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. • 2.4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
  19. 19. • 2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol. • 2.6 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.
  20. 20. • 2.7 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. • 2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
  21. 21. • 2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation. • 2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
  22. 22. • 2.11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). • 2.12 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. • 2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.
  23. 23. GCP in India The Main regulatory laws operating in India are the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics Rules (1945). SCHEDULE Y Import and/ or manufacture of new drugs Clinical trials
  24. 24. The latest amendment in Schedule Y says: • The clinical trial Sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the clinical trial is conduced and data generated, documented and reported in compliance with the protocol and GCP Guidelines
  25. 25. Pre-requisites for the study Investigational Pharmaceutical Product Pre-Clinical supporting data Protocol Ethical & Safety Considerations Record Keeping and Data Handling Statistics Responsibilities Sponsor The Monitor Investigator Quality Assurance All research involving human subjects should be conducted in accordance with the ethical principles contained in the current revision of Declaration of Helsinki
  26. 26. Principles of essentiality • Whereby, the research entailing the use of human subjects is considered to be absolutely essential after a due consideration of all alternatives Principles of voluntariness, informed consent and community agreement • Full information about the study • Written and informed consent • Risk and harm arising from the study • Right to withdraw from the study voluntarily Principles of non-exploitation • Involvement in the research or experiment; and, irrespective of the social and economic condition or status, or literacy or educational levels attained by the research subjects Principles of privacy and confidentiality • The identity and records of the human subjects of the research or experiment are as far as possible kept confidential
  27. 27. Principles of precaution and risk minimisation • It ensures that the research subject and those affected by it are put to the minimum risk, suffer from no irreversible adverse effects and, generally, benefit from and by the research or experiment. Principles of professional competence • The research is conducted at all times by competent and qualified persons Principles of accountability and transparency • The research or experiment will be conducted in a fair, honest, impartial and transparent manner Principles of the maximisation of the public interest and of distributive justice • The research or experiment and its subsequent applicative use are conducted and used to benefit all human kind
  28. 28. Principles of institutional arrangements • All arrangements should be made in a bonafide and transparent manner; • Ensure that research reports, materials and data connected with the research are duly preserved and archived. Principles of public domain • The research is brought into the public domain so that its results are generally made known through scientific and other publications Principles of totality of responsibility • whereby the professional and moral responsibility, for the due observance of all the principles, guidelines or prescriptions laid down generally or in respect of the research or experiment Principles of compliance • there is a general and positive duty on all persons, conducting, associated or connected with any research entailing the use of a human subject to ensure that both the letter and the spirit of these guidelines
  29. 29. • “Let not hatred of any people keep you from dealing justly. Deal justly, that is nearer to your duty. Observe your duty to God. Lo! God is Informed of what ye do." (Quran 5.8)
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Good Clinical Practices for drug discovery and development


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