Historically, clinical research has not reflected the diverse population of the United States when it comes to race, ethnicity, disability status, and other important factors. This leads to disproportionate health outcomes that can cost lives. How might we help to ensure that medical research participation is more representative of the U.S. population?
Note: This Challenge is still available to complete to earn points and add to your resumes! The prize money was awarded in the past to the following winners.
In the Explore phase, you'll learn about clinical trials: what they are, why they are important, and how they effect people. You do not need to watch or read every article, but by the end of the phase, you should be able to:
Explain what clinical trials are and why are they important
Demonstrate, with data, the lack of diversity in clinical trial participation
Discuss the impact of the lack of diversity
Identify examples of how the issue is currently being addressed
⏱️Time: 2- 4 Hours (Week 1 of the Challenge)
✏️Use the optional KNOtebook to record notes and questions
💼Mentor: Ask a mentor questions about the topic
🎯Future-Ready Skills: Social Awareness, Initiative and Self-Direction
So, what exactly is medical research? What's the history of it? Why is it important? In this section, you develop an understanding of the topic.
Review two or three of the videos to start to build your expertise. As you watch the videos, jot down interesting facts, numbers, statistics, quotes, dates, and other important or surprising information. Remember, you are building your background knowledge.
Understand the purpose of clinical trials and how they work (2:21)
Explore the phases of clinical trials (1:48)
Listen to one woman's story (0:57)
Take a look at some important events in the history of clinical trials.
Now that you have some background, it’s time to dig into the issue.
The iceberg is an analogy that depicts the many layers of the patient community, both visible and hidden. The "tip of the iceberg" are patients who are likely to join clinical trials, however, most patients are below the waterline. Consider the following as you view the framework:
Why are some populations more submerged than others?
What happens when people are part of more than one group?
How can medical research be more inclusive and create opportunities to reach all populations that are currently submerged?
Understand the importance of diversity in clinical research (2:53)
Check out COVID 19 trials in July 2020 (3:09)
Hear from doctors (3:31)
Clinical Research Jobs
Demand for clinical research is growing faster than the workforce is able to deliver it – a daunting challenge that delays medical innovation and undermines attempts to fulfill unmet clinical needs. In addition to the need for more diverse participants, the need for a more diverse workforce is also critical.
Hear more about this from Alana Miller, Associate Director, Clinical Trial Diversity Program Lead, Merck. And, visit the Association of Clinical Research Professionals to learn about this growing profession.
"Clinical research is a very lucrative career. We need more people like you!" (Alana Miller, Associate Director, Clinical Trial Diversity Program Lead, Merck)
Consider how different groups of people are impacted by lower participation in clinical research. Choose one to two groups below to learn more.
As you have seen, racial and ethnic minorities are underrepresented in clinical trials. Also, in Phase 1 of clinical trials, healthy participants are most likely low income, Black, or Hispanic. This is the most dangerous phase of the clinical trial process.
People with disabilities are often excluded from participating in clinical trials. The National Institute of Aging estimates that 50% of people with Down syndrome will develop Alzheimer's as they age. However, a recent federal proposal (2022) regarding a new class of treatment for Alzheimer's disease, specifically excludes people with Down Syndrome and other intellectual disabilities from participating in the clinical trials.
According to a study, lower-income people newly diagnosed with cancer were less likely to participate in clinical trials. After adjusting for age, sex, race, education level, travel distance, and stage of disease, the researchers found that people with an annual household income below $50,000 were 32% less likely to participate in the clinical trial than people with higher annual incomes.
Older adults are often excluded from clinical trials. An ongoing study by a Harvard Medical School professor examines ageism in clinical research and shows that around 15% of clinical trials for COVID-19 systematically excluded adults between 65-80 years-old. If vaccines are only tested on a younger population, there's a risk it may not work with older adults, who often have a higher risk of disease.
Children differ from adults, developmentally and physically, and because of this, clinical trials specifically for children are essential. Clinical trials in children are critical to developing age-specific, effective, and safe therapies and interventions. However, children are generally the last group to be tested.
Hear from people who have participated in clinical trials.
Hear about a teenager's experience (5:19)
Hear about barriers for minority participation in clinical trials (3:21)
Hear about the importance of African-American men's participation in clinical trials (3:38)
Hear from a Spanish-speaking woman about her experiences (3:10)
Remember, you're coming up with your own solution to this big problem. Take a look at a few ways others have addressed the issue of lack of representation in clinical trials.
On April 13, 2022, the Food and Drug Administration (FDA) issued a new draft guidance to the medical industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials.
Read the news release:
See examples of how the issue has been addressed by opening a "business", running a campaign, and creating a product,
Watch a creative business/organization approach to building awareness (3:10)
See an example campaign (1:17)
Explore an app (product) for clinical trial participants: https://bit.ly/3CFOOlu