Challenge 2: How are medications developed?
Learning Targets:
- I can identify different phases of clinical trials involved in drug development and approval.
- I can confront the history of disparities and injustice in drug development.
- I can apply lessons learned to the emergency use of medications for COVID-19.
Estimated Time: 90 minutes
Activity 1: Explain the process of drug development.
Watch: 3 videos
Continued...
Reflect & Discuss
- The process to make a new medication is very detailed. What are the pros and cons to such a complex process?
- If medications gain approval for use after successfully completing phase III trials, what is the purpose of phase IV trials?
Share
Your answers with the class.
Activity 2: Disparities and injustice in drug development.
Read:
- “Minorities Are Underrepresented in Clinical Trials”
- “Tuskegee Experiment: The Infamous Syphilis Study”
Watch:
The History of Clinical Research Timeline
Continued...
Reflect & Discuss:
- Why might minority populations be underrepresented in clinical trials?
- How might historical injustices like the Tuskegee Experiments impact research and medical care today?
Explore
With a partner one of the following topics using online resources - The Nuremberg Code or Henrietta Lacks. Share your answers and what you learned with the class.
Activity 3: Emergency use of medications for COVID-19
Watch
What is an EUA?
Continued...
Read:
- “Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment”
- “FDA ends emergency use authorization for hydroxychloroquine to treat COVID”
- “Scientists Are Wrong All the Time, and That’s Fantastic”
Reflect & Discuss
- Why does the process of Emergency Use Authorization exist?
- What are some risks to fast-forwarding the normal process of approving medications?
- How can we trust scientists (like the researchers who make new medicines) when they are wrong so much of the time?
Share
Your answers with the class.
Drug Discovery at Yale