Homework #3

(15 pts)

Read the following articles from From Test Tube to Patient: Improving Health Through Human Drugs at the FDA/CDER Web site (http://www.fda.gov/cder/about/)

Note: A direct link to this article is available on the CHE 300 web page under the Supplemenatry Material for Lecture 12, along with a link to Adobe Acrobat Reader which you will need to download, if you do not already have it, to read the pdf file.

After reading these articles answer the following questions:

1) Define what is meant by the control group in a controlled study of a clinical trial. What are the different options for how the control group is treated in a controlled study?

2) Define the following terms/concepts as they relate to a controlled study in a clinical trial:

3) With-holding a potentially life-saving drug from patients in a control group in a clinical trial has often been a concept that is hard for researcher's to defend. Critics of this technique argue that it violates the ethical principle that if a life-saving drug is available a patient can not be denied it. What methods have been adopted by the FDA to assure that patients in the control group are exposed to unnecessary risk by their participation in a trial?

4) Individuals who are critically ill with conditions for which no effective treatments are currently approved can sometimes obtain access to experimental drugs that have not yet passed all phases of a clinical trial. Describe two ways the FDA/CDER makes this possible.

5) Dosages for children are often determined from adult dosages using Clark's Rule. Why is this sometimes problematic?

6) Name two drugs that have been found safe in adults, but have led to medical problems when taken by children.

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