H_Bio_-_Clinical_Trials_-_background_2008 - 2 Why is it...

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Name: _________________ Date: ______________ Period: ________ Clinical Trials – Independent Investigation http://www.fda.gov/fdac/special/testtubetopatient/default.htm Click on the link titled “Inside Clinical Trials: Testing Medical Products on People” and read the information provided. As you read, answer the questions below. Answers must be hand written . You may either print this page & fill in your answers or you may copy each question and then answer it on lined paper. Note: Before a drug starts being tested in humans, studies are done in animals to determine its toxicity and its safety at different doses. The manufacturer then writes an IND Application (Investigational New Drug) and sends it to the FDA. This comprehensive document describes the chemical properties of the drug, its purity, and a detailed description of the protocol used to test the drug. Answer the following questions: 1. What is the purpose of a clinical trial?
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Unformatted text preview: 2. Why is it important to have a variety of people enrolled in clinical trials? 3. Define each of the terms using the text. (They are not all in one place – read through the end.) a. Inclusion / exclusion criteria b. Protocol c. placebo 4. List the major differences between Phase I, Phase II, and Phase III clinical trials. You may use a chart if you wish, but please be clear about what you are saying. 5. Read through the text and list all the ways a patient is protected during a clinical trial. Consider their privacy, safety, health, etc. 6. Explain why double-blind studies are critical in evaluating the results of a clinical trial. 7. Read the paragraph “Identifying Important Variables” in section 1.6 in your textbook. Suppose you were to investigate the effect of a Drug X on the occurrence of heart attacks. List all the possible variables that would have to be identical between the control group and the experimental group....
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H_Bio_-_Clinical_Trials_-_background_2008 - 2 Why is it...

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