Zoey Agle
Clinical trials have been getting a lot of attention lately because of the numerous COVID-19 vaccine trials currently underway. With these highly publicized trials have come many questions about how the vaccines work and their efficacy. One important consideration that has also been getting a fair amount of attention is whether the groups of people participating in these trials are representative of the public at large.
Achieving a diverse group of research subjects in clinical trials is crucial to ensuring that a drug or treatment will be effective for everyone and how its effects may vary. Lifestyle and genetics can dramatically influence how a drug works. For example, a 2014 study found that about 20% of the drugs approved by the FDA over a five year span caused variable reactions between ethnic groups (Hewings, 2020). This illustrates how attaining a diverse pool of research subjects is the duty of a research team so they can confidently give a drug or treatment to the public, and the NIH does require the inclusion of women and minorities in these trials for this reason (NIH, 2001). However, we still see dramatic underrepresentation of minorities in clinical trials. Overall, African-Americans make up only about 5% of participants in clinical trials, despite making up about 13% of the US population (Frederick et al, 2020). So why do we see so few research subjects of color despite the NIH and scientists understanding the immense importance of their inclusion? Because mistrust and logistics often get in the way.
There have been ample studies over the years looking into why people belonging to different minority groups participate less in research trials, and one of the reasons that repeatedly comes up is mistrust. This mistrust of research participation can stem from a few sources, one of which being historical mistreatment. For example, in a study assessing mistrust of research participation among African-Americans, researchers found that many participants across socioeconomic backgrounds brought up historical events, including the Tuskegee syphilis study that became public in the 1970s (Scharff et al. 2010). This was a study, which ran from 1932 to 1972, in which black men with syphilis were not properly informed of their diagnoses and were not given treatments despite effective treatments being widely used (CDC, 2020). Another historical misgiving that still weighs on the minds of African-Americans is the story of Henrietta Lacks (Frederick et al, 2020). Lacks was a black woman with cervical cancer who died in 1951. Without her consent, a sample of her cancer cells was experimented on and the cells were found to survive long-term in a dish, unlike other cells. Eventually there was widespread use of her cells, called HeLa cells, because of their utility, however neither Lacks nor her family ever got any of the money that was made selling her cells for research (Adey et al, 2013). These terrible stories of African-Americans being taken advantage of by medical researchers make it very clear why in the modern day they would still be hesitant, and tales like these are not restricted to African-Americans.
Unfortunately though, the sources of mistrust do not end there with decades old mistreatment. In their daily lives, minority individuals see discrimation in the US medical system, making them less likely to trust it. The same study of African-American mistrust also found that many participants listed this as a factor. The biases of medical professionals cause minority patients to receive less attention, empathy, and information than white patients (Scharff et al. 2010). This lack of communication received by minority patients from doctors feels scarily reminiscent of historical misgivings, like the Tuskegee study. Not having a dialogue between patient and doctor also leaves minority patients less informed about their treatment and research trials in which they could participate. Ultimately ethnic minority patients end up getting worse medical treatment than white patients, so they often do not want to sign up for a clinical trial where this would likely also be the case but with a new treatment, whose effectiveness and side effects are unknown (Scharff et al. 2010).
Aside from mistrust based on historical and modern discrimination, often minority individuals face logistical barriers to participation in clinical trials. For example, Native American reservations are often very far from research centers. In one study looking at participation of Native Americans and Alaska Natives in research, they found that the average distance participants would have to travel to the nearest hospital or cancer center was 50 miles (Sprague et al, 2014). In addition, studies often do not provide adequate incentives that make traveling long distances and taking time off of work worth the participation in clinical trials (Frederick et al, 2020). Clinical studies also often fail to address language barriers and cultural differences that would make it less difficult and uncomfortable for minority individuals to participate (Hewings, 2020).
This article is not a comprehensive list of the barriers to more participation in research by minorities. However, those that are listed are some of the biggest ones, and they can be addressed by researchers and government organizations. Because it is so important that clinical trials be representative of the American population at large, individual research teams and their institutions should begin providing better incentives for minority individuals to participate and they should bring some of the research directly into these communities. Though there is already some implicit bias training in medicine, it should be expanded and altered to ensure, based on research, that it has its intended effects. Government organizations, like the NIH, need to be transparent about past breaches of ethics in research, as well as what they have done and continue to do to prevent them now. This is an important way to open the line of communication with minority communities so they can understand the facts and feel more comfortable seeking help in medicine. These suggestions are also not comprehensive, but they make a good starting place to make minority individuals feel more comfortable being a necessary part of medical research.
References:
Adey A, Burton JN, Kitzman JO, Hiatt JB, Lewis AP, Martin BK, Qiu R, Lee C, and Shendure J.
2013. The haplotype-resolved genome and epigenome of the aneuploid HeLa cancer cell
line. Nature. 500:207-211.
Frederick WAI, Rice VM, Carlisle DM, and Hildreth JEK. 2020. We Need to Recruit More
Black Americans in Vaccine Trials [Internet]. New York (NY): New York Times; cited [2020 Dec 9]. Available from https://www.nytimes.com/2020/09/11/opinion/vaccine-testing-black-americans.html?sea
chResultPosition=5
Hewings Y. 2020. Increasing diversity in clinical trials: What can doctors, regulators, and
patients do? [Internet]. Brighton (UK): Medical News Today; cited [2020 Dec 9].
Available from
https://www.medicalnewstoday.com/articles/increasing-diversity-in-clinical-trials-what-
an-doctors-regulators-and-patients-do#What-can-the-FDA-do?
NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical
Research [Internet]. 2001. Bethesda (MD): NIH; cited [2020 Dec 9]. Available from
https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm#:~:text=It%20is%20the%20policy%20of,that%20inclusion%20is%20inappropriate%20with
Scharff DP, Mathews KJ, Jackson P, Hoffsuemmer J, and Edwards D. 2010. More than
Tuskegee: Understanding Mistrust about Research Participation. J Health Care Poor
Underserved. 21(3):879-897.
Sprague D, Russo J, LaVallie DL, and Buchwald D. 2014. Barriers to Cancer Clinical Trial
Participation Among American Indian and Alaska Native Tribal College Students. J
Rural Health. 29(1):55-60.
The Tuskegee Timeline [Internet]. 2020. Atlanta (GA): The CDC; cited [2020 Dec 9]. Available
from https://www.cdc.gov/tuskegee/timeline.htm
Image: Geralt. 2020. Diversity Human Group Personal Silhouettes [Internet]. iStock; [updated
2020 Sept 4; cited 2020 Dec 8]. Available from: https://pixabay.com/illustrations/diversity-human-group-personal-5541062/
Achieving a diverse group of research subjects in clinical trials is crucial to ensuring that a drug or treatment will be effective for everyone and how its effects may vary. Lifestyle and genetics can dramatically influence how a drug works. For example, a 2014 study found that about 20% of the drugs approved by the FDA over a five year span caused variable reactions between ethnic groups (Hewings, 2020). This illustrates how attaining a diverse pool of research subjects is the duty of a research team so they can confidently give a drug or treatment to the public, and the NIH does require the inclusion of women and minorities in these trials for this reason (NIH, 2001). However, we still see dramatic underrepresentation of minorities in clinical trials. Overall, African-Americans make up only about 5% of participants in clinical trials, despite making up about 13% of the US population (Frederick et al, 2020). So why do we see so few research subjects of color despite the NIH and scientists understanding the immense importance of their inclusion? Because mistrust and logistics often get in the way.
There have been ample studies over the years looking into why people belonging to different minority groups participate less in research trials, and one of the reasons that repeatedly comes up is mistrust. This mistrust of research participation can stem from a few sources, one of which being historical mistreatment. For example, in a study assessing mistrust of research participation among African-Americans, researchers found that many participants across socioeconomic backgrounds brought up historical events, including the Tuskegee syphilis study that became public in the 1970s (Scharff et al. 2010). This was a study, which ran from 1932 to 1972, in which black men with syphilis were not properly informed of their diagnoses and were not given treatments despite effective treatments being widely used (CDC, 2020). Another historical misgiving that still weighs on the minds of African-Americans is the story of Henrietta Lacks (Frederick et al, 2020). Lacks was a black woman with cervical cancer who died in 1951. Without her consent, a sample of her cancer cells was experimented on and the cells were found to survive long-term in a dish, unlike other cells. Eventually there was widespread use of her cells, called HeLa cells, because of their utility, however neither Lacks nor her family ever got any of the money that was made selling her cells for research (Adey et al, 2013). These terrible stories of African-Americans being taken advantage of by medical researchers make it very clear why in the modern day they would still be hesitant, and tales like these are not restricted to African-Americans.
Unfortunately though, the sources of mistrust do not end there with decades old mistreatment. In their daily lives, minority individuals see discrimation in the US medical system, making them less likely to trust it. The same study of African-American mistrust also found that many participants listed this as a factor. The biases of medical professionals cause minority patients to receive less attention, empathy, and information than white patients (Scharff et al. 2010). This lack of communication received by minority patients from doctors feels scarily reminiscent of historical misgivings, like the Tuskegee study. Not having a dialogue between patient and doctor also leaves minority patients less informed about their treatment and research trials in which they could participate. Ultimately ethnic minority patients end up getting worse medical treatment than white patients, so they often do not want to sign up for a clinical trial where this would likely also be the case but with a new treatment, whose effectiveness and side effects are unknown (Scharff et al. 2010).
Aside from mistrust based on historical and modern discrimination, often minority individuals face logistical barriers to participation in clinical trials. For example, Native American reservations are often very far from research centers. In one study looking at participation of Native Americans and Alaska Natives in research, they found that the average distance participants would have to travel to the nearest hospital or cancer center was 50 miles (Sprague et al, 2014). In addition, studies often do not provide adequate incentives that make traveling long distances and taking time off of work worth the participation in clinical trials (Frederick et al, 2020). Clinical studies also often fail to address language barriers and cultural differences that would make it less difficult and uncomfortable for minority individuals to participate (Hewings, 2020).
This article is not a comprehensive list of the barriers to more participation in research by minorities. However, those that are listed are some of the biggest ones, and they can be addressed by researchers and government organizations. Because it is so important that clinical trials be representative of the American population at large, individual research teams and their institutions should begin providing better incentives for minority individuals to participate and they should bring some of the research directly into these communities. Though there is already some implicit bias training in medicine, it should be expanded and altered to ensure, based on research, that it has its intended effects. Government organizations, like the NIH, need to be transparent about past breaches of ethics in research, as well as what they have done and continue to do to prevent them now. This is an important way to open the line of communication with minority communities so they can understand the facts and feel more comfortable seeking help in medicine. These suggestions are also not comprehensive, but they make a good starting place to make minority individuals feel more comfortable being a necessary part of medical research.
References:
Adey A, Burton JN, Kitzman JO, Hiatt JB, Lewis AP, Martin BK, Qiu R, Lee C, and Shendure J.
2013. The haplotype-resolved genome and epigenome of the aneuploid HeLa cancer cell
line. Nature. 500:207-211.
Frederick WAI, Rice VM, Carlisle DM, and Hildreth JEK. 2020. We Need to Recruit More
Black Americans in Vaccine Trials [Internet]. New York (NY): New York Times; cited [2020 Dec 9]. Available from https://www.nytimes.com/2020/09/11/opinion/vaccine-testing-black-americans.html?sea
chResultPosition=5
Hewings Y. 2020. Increasing diversity in clinical trials: What can doctors, regulators, and
patients do? [Internet]. Brighton (UK): Medical News Today; cited [2020 Dec 9].
Available from
https://www.medicalnewstoday.com/articles/increasing-diversity-in-clinical-trials-what-
an-doctors-regulators-and-patients-do#What-can-the-FDA-do?
NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical
Research [Internet]. 2001. Bethesda (MD): NIH; cited [2020 Dec 9]. Available from
https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines.htm#:~:text=It%20is%20the%20policy%20of,that%20inclusion%20is%20inappropriate%20with
Scharff DP, Mathews KJ, Jackson P, Hoffsuemmer J, and Edwards D. 2010. More than
Tuskegee: Understanding Mistrust about Research Participation. J Health Care Poor
Underserved. 21(3):879-897.
Sprague D, Russo J, LaVallie DL, and Buchwald D. 2014. Barriers to Cancer Clinical Trial
Participation Among American Indian and Alaska Native Tribal College Students. J
Rural Health. 29(1):55-60.
The Tuskegee Timeline [Internet]. 2020. Atlanta (GA): The CDC; cited [2020 Dec 9]. Available
from https://www.cdc.gov/tuskegee/timeline.htm
Image: Geralt. 2020. Diversity Human Group Personal Silhouettes [Internet]. iStock; [updated
2020 Sept 4; cited 2020 Dec 8]. Available from: https://pixabay.com/illustrations/diversity-human-group-personal-5541062/
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