Glod_11072007 - Principles and Ethics of Clinical Research...

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Principles and Ethics of Clinical Research John Glod, M.D., Ph.D. Departments of Pediatrics and Pharmacology Robert Wood Johnson Medical School The Cancer Institute of New Jersey
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Goals of clinical research • New therapies • Improving outcomes • Reducing toxicities/side effects
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History of clinical research • Herophilos (335-280 BC) • Avicenna (980-1037) • Edward Jenner (1749-1823) • Walter Reed (1851-1902)
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Herophilos (335-280 BC) • Began to use scientific inquiry in medicine. • -used dissection • -recognized brain as center of nervous system • -described difference between arteries and veins • -described changes in the pulse with disease states
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Avicenna (980-1037) • Introduced experimentation into medicine and the idea of a clinical trial.
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Ibn Sina •TB • Diabetes
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Avacenna 1.The drug must be free from any extraneous accidental quality. 2. It must be used on a simple, not a composite, disease. 3. 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. 4. 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. 3. The time of action must be observed, so that essence and accident are not confused. 4. 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. 5. The experimentation must be done with the human body, for testing a drug
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Glod_11072007 - Principles and Ethics of Clinical Research...

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