solved: 1 Do you think it is appropriate for a pharmaceutical

solved: 1 Do you think it is appropriate for a pharmaceutical

solved: 1 Do you think it is appropriate for a pharmaceutical
1. Do you think it is appropriate for a pharmaceutical firm to conduct most of its clinical trials in less developed countries? Why or why not? 2. The Food and Drug Administration (FDA) in the United States requires that all trials submitted to it meet internationally accepted guidelines, known as Good Clinical Practice, that demand “the establishment of local review boards; ask government ministries to approve all trials before they begin; warn against excessive payment to doctors; and outline how they obtain informed consent and avoid taking advantage of vulnerable patients.” But as noted by Ward Cates, president of the research arm of nonprofit Family Health International, “how do you meet procedures required by the FDA in settings where electricity is going off two hours a day?” In your view, how can a pharmaceutical company ensure that clinical trials meet the FDA standards noted above? Is this realistic? Explain your answer. 3. Some companies argue that, costs savings aside, there are important benefits to more clinical trials overseas. From a mechanical standpoint, testing on ethically diverse populations may offer more insight into the ways drugs can affect different people. And patients which would otherwise not receive any help get medication and treatment during the trials. Lastly, it helps drug companies penetrate new markets badly in need of new treatments. Russia’s drug market is estimated at $5 billion this year, India’s at $5.4 billion. Do you believe that these positive aspects outweigh potential problems with clinical trials overseas? Why or why not? Should the U.S. government become more involved in regulating these practices? Explain. View Solution:
solved: 1 Do you think it is appropriate for a pharmaceutical