Project #64993 - Discussion

The Story of Thalidomide

The story of the Thalidomide studies marked a significant and tragic event in the history of clinical research. It raised fundamental ethical questions about conducting clinical trials, and it led to regulatory guidance and standards of conduct in the United States and internationally. This Discussion will explore that regulation and guidance.

To prepare for this Discussion:

• Review this week’s Learning Resources.
• Review the following Web site:http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdf
.
• Review the guidelines set forth by the International Conference on Harmonisation.
• Reflect on the tragedies that resulted in today’s regulatory oversight.
• Consider the following statement: It has been said that the United States was able to avert the Thalidomide tragedy that occurred in Europe by refusing to approve the drug, which resulted in unnecessary delays in the approval of many useful drugs.

Post by Day 4 a comment about the following question: Given that Thalidomide is now accepted as an effective treatment for leprosy, do you feel that Dr. Frances Kelsey was correct in stopping the development of Thalidomide in the United States in 1960?

Subject Science
Due By (Pacific Time) 04/07/2015 12:00 am
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