FDA PUBLICATION

Find an article in a recent publication in the media that addresses a topic related to substance use or abuse. Your reaction paper should briefly explain the content of the article and offer your perspective on the topic. Some questions you may want to address: Did the article accurately reflect the research cited? Is this area of research important? What are the implications of these findings? Strengths/weaknesses? What kind of questions does this raise? Are there ethical concerns? Submit a copy of the article with your response.

  • 2 FDA PUBLICATION: Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
  • rec fda trials _1_.pdf
  • White-Paper-on-the-Dialogues-on-Diversifying-Clinical-Trials-Conference _1_.pdf
  • https://www.sciencealert.com/male-dominated-clinical-trials-have-lead-to-dangerously-overmedicated-women

Answer: What are some practical changes that can be made in order to ensure that a more diverse sample is able to participate? Who typically participates in clinical trials? Which groups are underrepresented in clinical trials and why? Why do you think such a homogenous group of people participate in clinical trials today? Is this area of research important? What are the implications of this publication? Strengths/weaknesses? Are there ethical concerns?

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