Good Intentions
October 27, 2020
Photo by Marco Verch licensed under CC BY 2.0
With communities of color disproportionately impacted by COVID-19, drugmakers and public health officials are placing an unprecedented emphasis on diversity in vaccine clinical trials.
Listen to the full episode below, read the transcript or scroll down for more information.
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The Basics: The Search for a COVID-19 Vaccine
Pharmaceutical companies, academic institutions and governments around the world are working at an unprecedented pace to develop a COVID-19 vaccine. The United States government has invested more than $10 billion into helping companies develop, manufacture and eventually distribute a vaccine. As of October 2020, 11 vaccine candidates had entered Phase III human efficacy trials worldwide, including five in the U.S.
While a vaccine is seen as a critical step to controlling the pandemic, polls show a growing number of Americans would not get a COVID-19 vaccine if it were available today. This stems from a combination of pre-existing anti-vaccine sentiment and concerns that the vaccine approval process is being driven by politics, not science.
The Problem: Lack of Representation in Clinical Trials
Vaccine hesitancy is higher among Black Americans than other racial and ethnic groups.
Experts says this is part of a larger mistrust of the medical establishment driven by experiences of racism within the health care system and a history of being treated as medical test subjects. This includes the infamous “Tuskegee experiment,” in which hundreds of Black men were used by researchers for decades to study the effects of syphillis. The men were not told they had the disease, and they were not given any treatment.
At the same time, pharmaceutical clinical trials have historically failed to include people of color and women at representative numbers. The Food and Drug Administration and National Institutes of Health have implemented policies designed to increase representation of women and minorities in clinical trials, but the problem persists. In a recent review of cancer clinical trials, Black Americans and Hispanics were consistently underrepresented.
¹Jonathan M. Loree, Seerat Anand, Arvind Dasari, Joseph M. Unger, Anirudh Gothwal, Lee M. Ellis, Gauri Varadhachary, Scott Kopetz, Michael J. Overman and Kanwal Raghav. “Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018.” JAMA Oncology, 2019
²Anuradha Ramamoorthy, Michael Pacanowski, Jonca Bull and Lei Zhang. “Racial/ethnic differences in drug disposition and response: Review of recently approved drugs.” Clinical Pharmacology & Therapeutics, 2015
³Liz Hamel, Lunna Lopes, Cailey Muñana, Samantha Artiga and Mollyann Brodie. “KFF/The Undefeated Survey on Race and Health.” Oct. 13, 2020
With Black people having the highest per capita death rate of any racial or ethnic group from COVID-19 — including dying at more than twice the rate of white people — making sure that any vaccine is effective and trusted among Black Americans is incredibly important.
What's Happening Now: Diversity in COVID-19 Vaccine Trials
Drugmakers and regulators say they are committed to diverse participation in COVID-19 vaccine trials. While there are no specific diversity mandates from the FDA, some of the companies running vaccine clinical trials say they are being told to increase minority representation in their trials in ways they have not ever before.
“They’re saying, ‘OK, you have to stop enrolling Caucasian people right now, we have plenty,” says Beau Garland, Vice President of Recruitment for Meridian Clinical Research, which is running nine trials across the country for various drugmakers. “Now we need to focus on African Americans or Hispanic[s] or Asian[s] because they are really looking to get racial diversity that somewhat mimics the United States.”
Garland says recruiting minority participants has been difficult, especially because the pandemic has limited the ability to do in-person recruitment. Moderna, which has one of the furthest along Phase III trials, said it slowed enrollment in its trial in September in order to increase minority representation, and reported in October that 37% of its final trial participants were people of color, including 10% Black Americans.
Solutions: How to Make Clinical Trials More Diverse
“There’s nothing magic or different about approaching minority communities” to participate in clinical trials, says Jonathan Jackson, who founded and directs the Community Access, Recruitment and Engagement Center (CARE) at Massachusetts General Hospital and Harvard Medical School.
Here are a few strategies Jackson recommends to increase diversity in clinical trials:
Start Early
Building relationships and overcoming well-founded fears about participating in clinical trials takes time. "As soon as you have a trial in mind, you need to start engaging with the communities you want to see," Jackson says.
Involve the Community
Jackson says it is important to involve members of minority communities throughout the research process — not just as trial participants, but also on ethical review boards and study teams. He points to American Indian and Alaska Native tribes that have set up their own independent review boards as a model.
Make Participation Easier
Jackson says clinical trials often take place at inconvenient times and places that make them difficult for people with jobs and families to participate, regardless of race or ethnicity.
Educate People
"We need to go out and explain what the heck clinical trials are and how that process of science even works," Jackson says. This is especially important in communities that have historically been subjected to racism and experimentation by the medical profession.
In addition to these efforts, Jackson says it’s important for drugmakers and researchers to expand their definition of diversity beyond race, ethnicity and gender, and to look at differences within participants of the same race (like how much money they make and where they live) to get the most accurate understanding of why they respond to a drug or vaccine in a certain way.
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Episode Resources
Select Reporting and Research on COVID-19 Disparities:
COVID-19 Racial Data Tracker (COVID Tracking Project)
COVID-19 Hospitalization and Death by Race/Ethnicity (Centers for Disease Control and Prevention, 8/18/2020)
Racial Disparities in COVID-19: Key Findings from Available Data and Analysis (Samantha Artiga, Bradley Corallo and Olivia Pham; Kaiser Family Foundation; 8/17/2020)
New poll shows Black Americans see a racist health care system setting the stage for pandemic’s impact (Michael A. Fletcher, The Undefeated, 10/13/2020)
Select Research and Reporting on Diversity in Vaccine Clinical Trials:
Racial/ethnic differences in drug disposition and response: Review of recently approved drugs (Anuradha Ramamoorthy, Michael Pacanowski, Jonca Bull and Lei Zhang; Clinical Pharmacology & Therapeutics; 12/13/2014)
Black Patients Miss Out On Promising Cancer Drugs (Caroline Chen and Riley Wong, ProPublica, 9/19/2018)
Increasing Diversity in Clinical Trials: Overcoming Critical Barriers (Luther T. Clark, Laurence Watkins, Ileana L.Piña, Mary Elmer, Ola Akinboboye, Millicent Gorham, Brenda Jamerson, Cassandra McCullough, Christine Pierre, Adam B. Polis, Gary, Puckrein and Jeanne M.Regnante; Current Problems in Cardiology; May 2019)
2019 Drug Trials Snapshot Summary Report (U.S. Food and Drug Administration)
Select Research and Reporting on COVID-19 Vaccine Diversity:
Coronavirus Vaccine Tracker (New York Times)
Half of Black adults say they won’t take a coronavirus vaccine (Lonnae O’Neal, The Undefeated, 10/13/2020)
KFF/The Undefeated Survey on Race and Health (Liz Hamel, Lunna Lopes, Cailey Muñana, Samantha Artiga and Mollyann Brodie; Kaiser Family Foundation and the Undefeated; 10/13/2020)
Moderna slows coronavirus vaccine trial enrollment to ensure minority representation, CEO says (Meg Tirrell and Leanne Miller, CNBC, 9/4/2020)
Episode Credits
Guests:
Beau Garland, Vice President of Recruitment, Meridian Clinical Research
Jonathan Jackson, PhD; Director; Community Access, Recruitment, and Engagement (CARE) Research Center
The Tradeoffs theme song was composed by Ty Citerman, with additional music this episode from Blue Dot Sessions.
This episode was reported and produced by Sabrina Emms. It was mixed by Andrew Parrella. It was produced for the web by Ryan Levi.
Additional thanks to:
Katrina Armstrong, Harald Schmidt, and Vladimir Berthaud, the Tradeoffs Advisory Board…
…and our stellar staff!