Module 5 Presentations

05/07/2024

Additional cases (2)

• World War II - Nazi doctors experiments on people in concentration camps.

• 1951 Dr. Albert Kligman undertook dermatological experiments on prisoners at Holmesburg Prison without their consent. • Russia – „komnata“ (development of the poisoning substance C2) - the effect of different poisons tested on the prisoners in Gulag.

The Organisation for Professionals in Regulatory Affairs

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Development of GCP Clinical trial (1)

• The first mention of a clinical trial appears to be in the bible in the Book of Daniel, which contains a reference to an “accidental” clinical study conducted in the reign of King Nebuchadnezzar II (605–562 BC). • He decided that his “ study subjects ” should be fed a strict diet of meat and wine as he believed this would make them a stronger race.

• Four of his subjects of royal blood, including Daniel, refused this diet and instead ate pulses such as wheat and lentils and drank only water. • After ten days the king saw that those consuming pulses and water were fitter than those on the meat and wine diet.

The Organisation for Professionals in Regulatory Affairs

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