Clinical Trials

Clinical trials are a crucial step in the development of drugs and medical devices to ensure the safety and validity of products for patient use. However, more and more companies are moving their clinical trials to low resource settings to save time and money. Watch this video to learn about the impacts that clinical trials have on lower-income countries and the ethical considerations that must be accounted for when using experimental products on vulnerable populations.

Self-Assessment Questions:

Click here to test your understanding on clinical trials in biomedical engineering.

Discussion Questions:

1. Given the current COVID-19 pandemic, research how vaccine companies Pfizer and Moderna have conducted their clinical trials. What percentage of participants were from LMICs? Consider the ethics of current practices in these trials, and explain your opinion.
2. Based on Gupta et al., what are two main ethical considerations to consider when distributing COVID-19 vaccines across communities?
3. How should companies ensure that their impacts on the populations tested are positive in the long term?
4. As bioengineers, how can we apply some of these principles of ethics when designing our own clinical experiments/building medical devices?

Continue Reading:

• Saha et al. (1986). Ethical Responsibilities of the Clinical Engineer. Journal of Clinical Engineering, 11(1), 17–26. doi: 10.1097/00004669-198601000-00004
  • This article overviews the necessary ethical responsibilities of an engineer engaging in clinical studies or trials. Note: This article may not be available due to subscription permissions.
• Gupta R, Morain SR. Ethical allocation of future COVID-19 vaccines. Journal of Medical Ethics 2021; 47:137-141. doi: 10.1136/medethics-2020-106850
  • This article explores the ethicality of distributing future COVID-19 vaccines and reviews five different vaccine prioritization methods for distribution.

About the Creator:

This video was created by a student in the Rice Bioengineering Class of 2023 (used with permission).