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Good Clinical Practice: Ensuring Ethical and Scientific Standards in Biomedical Research

This article discusses the importance of good clinical practice (GCP) in biomedical research, highlighting its role in protecting the rights, safety, and well-being of trial participants. It covers the key principles of GCP, including informed consent, confidentiality of records, and quality of data. The article also provides guidance on the operational procedures of ethics committees and the importance of laboratory quality assurance in clinical trials.

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Good Clinical Practice: Ensuring Ethical and Scientific Standards in Biomedical Research

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  1. Good Clinical Practice Juntra Karbwang MD, DTM&H, PhD WHO/TDR, Geneva, Switzerland

  2. A need for Biomedical Research The role of disease endemic countries in biomedical research is increasingly important to the solution of urgent health problems, to the fight against disease and to improvement of global health in general

  3. WHO/TDR POLICY • Clinical trial must be planned and conducted to reliable standards GCP • Extending respect for human rights without prejudice to local variations in attitudes and beliefs

  4. Concept of GCP Good Clinical Practice (GCP) is an international ethical and scientific quality standard Designing Conducting Recording Reporting Trials that involve participation of human subjects

  5. Clinical Trial Conduct in accordance with: • Ethical Principles • Declaration of Helsinki • Good Clinical Principles • Regulatory requirements

  6. Before initiation of aTrial • Inconvenience • Risk Benefit for trial subject & Society

  7. Initiate & continue a Trial Only if anticipated benefit justify RISK

  8. Adequate non-Clinical and Clinical Information Support Proposed Clinical Trial

  9. GCP Basic Principles Protection of rights, safety, well-being of trial participants Credible clinical trial data

  10. Protection of Trial Subjects • Scientifically Sound • Present in a clear and detailed protocol • Conduct in compliance with IEC/IRB • approval protocol

  11. Medical Care & decision => Qualified Physician • Each individual involved => Qualified by Education, Training & Experience Protection of Trial Subjects

  12. Protection of Trial Subjects The rights, Safety & Well-being Must always... Prevail over the interest of Science & Society

  13. Adequately Informed: Aims Methods Anticipated benefit Potential Hazards Protection of Trial Subjects

  14. Protection of Trial Subjects Informed Consent “Freely given”

  15. Protection of Trial Subjects • Confidentiality of Record • that could identify Subject => Should be Protected • Respecting the privacy

  16. Quality of Data Trial Information Recorded Handled Stored Allows its accurate reporting interpretation & verification

  17. Product - manufactured } GMP - Handled - stored Quality of Data Use in accordance with Protocol

  18. Quality of Data Implement systems Assure the quality of every aspects of the trial

  19. Clinical Monitor Framework Manager Clinical Coordinator DSMB Ethics Committee Investigator

  20. Ethical Review is required • As a support and a guide to the conscience of the physician • For the protection of research subjects • For public assurance

  21. Operational Guidelines for Ethics Committees That Review Biomedical Research The aim of these guidelines is to provide guidance for ethics committees concerning appropriate operating procedures

  22. The Aim of the Operational Guidelines To foster an improved understanding and implementation of ethical review in all countries in the world. To establish a vehicle for discussing and sharing understanding around the ethical issues.

  23. Credible Data • Monitoring • Investigators • Infra-structure at the site • QA/QC Laboratory support

  24. MONITORING VISITS Pre - Trial Monitoring visit: Ensure feasibility in the centre and interest of the investigator. Trial Initiation visit : Deliver study material, documents, products and make sure the investigational team understands the protocol and GCP requirements. Monitoring visit : Make sure the study is conducted according to the protocol and GCP and help the investigational team in solving problems. Close-out visit : Make sure the investigator file is archived properly and collect back all unused material, documents or products.

  25. Laboratory Quality Assurance Normal Lab Values QA/QC SOPs

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