Good Clinical Practices Its origins. GCP Information Sessions November 2010

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1 Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Good Clinical Practices Its origins GCP Information Sessions November 2010

2 Objective To briefly describe the evolution of Good Clinical Practices, and the eventual development of Division 5 of the Food and Drug Regulations.

3 History of Clinical Research The Canon of Medicine (1025) Avicenna (Ibn Sīnā) Persian scientist/physician Rules for the experimental use and testing of drugs Used in medical schools until 1650 Principles of medicine still taught in US universities

4 Avicenna s Rules The drug must be free from any extraneous accidental quality. It must be used on a simple, not a composite, disease. The drug must be tested with two contrary types of diseases, because sometimes a drug cures one disease by its essential qualities and another by its accidental ones. The quality of the drug must correspond to the strength of the disease. For example, there are some drugs whose heat is less than the coldness of certain diseases, so that they would have no effect on them. The time of action must be observed, so that essence and accident are not confused. The effect of the drug must be seen to occur constantly or in many cases, for if this did not happen, it was an accidental effect. The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on man.

5 History of Clinical Research (cont d) A Treatise of the Scurvy (1753) James Lind Scottish naval surgeon Experiment on 12 seamen 2 patients given 2 oranges and 1 lemon daily Partial to quasi-complete recovery after 6 days

6 The Nuremberg Code (1947) Subsequent Nuremberg Trials ( ) 23 defendants accused of Nazi experimentation on prisoners from concentration camps during the Second World War Dr. Leo Alexander 10 research ethics principles for human experimentation

7 Declaration of Helsinki (1964) World Medical Association Created in September 1947 Represents physicians Over a 100 countries Ties the Nuremberg Code to the Declaration of Geneva (1948), a statement of physician s ethical duties 6 revisions and 2 clarifications (1964 to 2008) Addresses more specifically clinical research using humans

8 Belmont Report (1979) Tuskegee Syphilis Study ( ) Conducted by the US Public Health Service in Tuskegee, Alabama About 400 African-Americans Research the natural progression of disease to find a cure 1947: standard treatment - penicillin Subjects were never treated until 1972

9 Belmont Report (1979) National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, US ( ) 1979 Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research 3 basic principles: respect for persons, beneficence and justice

10 International Conference on Harmonization ICH E6: Good Clinical Practice, Consolidated guideline International ethical and scientific quality standard for the design and conduct of clinical trials in human subjects as well as for the recording and reporting of clinical trial data. Describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and REBs. Finalised in May 1996 Adopted in 1997 by Canada

11 Division 5 Part C of the Food and Drug Regulations Came into force on September 1st, 2001 Enabled by the Food and Drugs Act Regulatory requirements for the sale and importation of drugs for use in human clinical trials Includes GCP (C ) Applies to all Phase I to Phase IV clinical trials Clinical trial applications submitted: Prior to September 1, 2001: Division 8, Part C, FDR On and after September 1, 2001: Division 5, Part C, FDR

12 Conclusion Good Clinical Practices endeavor to effect: increased safety and well-being of subjects; higher quality of clinical trials and resulting data. By way of: having a rigorous Inspection program; developing of more guidance for stakeholders; performing educational and consultative activities.