The History of Women and Clinical Trials – Scientific Journal

Name ______________________ BIOL 106: LAB ASSIGNMENT 1 The History of Women and Clinical Trials – Scientific Journal Reading Read the article “Women’s involvement in clinical trials: historical perspective and future implications” at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800017/ and answer the following questions. You may record answers with the wording used in the article. Put quotation marks around sentences/phrases taken directly from the article. BACKGROUND 1. List three categories of differences between women and men that are nonbiological. 2. What is “sex-based biology,” and why is it important to study in medicine? (two parts to this question) 3. Diseases can “disproportionately affect women.” Explain what this means and give two examples. (two parts to this question) 4. Diseases may also “present differently” in women compared to men. Explain what this means and give two examples. (two parts to this question) 5. In drug research, why is it important to use women as well as men as research participants? Give two examples. 6. Why did the FDA (Food and Drug Administration) begin a process of requiring “weight-based dosing” of certain drugs? HISTORICAL PERSPECTIVE 1. List three reasons why women were historically excluded from clinical trials in the U.S. Do these reasons relate to Unit 1 class information on inclusion of women in research studies? How? (three parts to this question) 2. List three events in Table 1 from the article that were discussed in the Unit 1 lecture guide/videos from class. 3. What was concluded by the FDA in 1992 regarding using women in clinical trials? 4. This article is posted on the NIH (National Institutes of Health) website. How well do you think they self-disclosed their own issues from the past, considering information on the NIH from Unit 1? (your opinion)