Uma Gupta

Mira Diamond-Berman
Melina Worthington

Final Review of Literature

Research Question: ​How does lack of diversity in medical experimental trials erode the quality of
healthcare provided to disadvantaged groups?

Introduction/ Rationale:
Socially, race is known as an imagined concept used to classify individuals by externally visible
factors such as skin tone, hair color, or eye color. Similarly, age and gender have been limited to use on a
social level to define different segments of the population. However, these differentiators are more than
just social constructs used to elevate or oppress given subgroups. They have measurable biological and
physiological implications in the realm of medicine, particularly that of drug reception and efficacy.
Between 2008 and 2013 one out of five novel pharmaceutical drugs elicited differences in reception and
response within minority groups as opposed to when used by white patients (“Collection of Race”).
Inconsistent response to medication amongst minorities is no coincidence. Rather, it is the result of unique
racial and ethnic variations in genetic information which have highly relevant biological implications
(Risch et al). Various genetic polymorphisms amongst minorities account for higher incidence of disease,
different exhibitions of chronic illness such as blood cancer, and inconsistencies in drug response.
Because polymorphisms tend to alter protein structure and metabolizing enzymes, they heavily impact
drug efficacy by revising absorption, metabolization, and excretion of pharmaceuticals for minorities
(Burroughs et al). In the past, Asian Americans have actually been harmed by medicine intended to treat
their illness due to poorly understood genetic polymorphisms within ethnic populations (“Collection of
Race”). Similarly, Puerto Rican and African American children were found to be less affected by
albuterol from asthma inhalers than European children because marginable sampling size disallowed for
sufficient study of ethnic intricacies in genetic response despite higher prevalence of asthma amongst
minorities (Chen and Wong). It is well known by pharmaceutical developers that change in only a single
base pair of DNA is enough to account for the generation of diseases such as sickle cell anemia and
Alzheimer's (Risch et al). Regardless, there continues to exist a dearth of accountability and interest when
it comes to ensuring that minorities are properly treated. If the existence of underlying genetic variation
amongst minority subgroups continues to go unaccounted for in research, already disadvantaged groups
will be further marginalized through lack of adequate healthcare (Chen and Wong).
Known genetic and biological differences expand beyond race. It has been shown that “​sex
differences can be observed in various disease states in prevalence, diagnosis, severity, and outcomes”
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
(Liu and Mager). Elderly patients, too, exhibit functional differences that influence their response and
access to treatment options. Organ abnormalities, decreased systemic function, and metabolism disorders
all increase with age, collectively decreasing the efficacy of given courses of treatment within elderly
segments of the population (Herrera). The implications of these known genetic and biological differences
amongst various segments of the population have been consistently ignored in clinical trials. Without
further study of genetic variation and accountability within the pharmaceutical community, disparities in
healthcare will continue to grow.
Despite the biological and genetic differences between people of different sexes, ages and
races/ethnicities, people of minority groups still lack representation in clinical trials. This lack of
participation is particularly dangerous for disadvantaged groups because clinical trials cannot determine
their potentially dangerous reactions to medical treatments. Under enrollment creates discrepancies in the
quality of medical treatment and the generalizability of study results, the consequences of which are
exacerbated by known genetic/biological differences amongst populations. This creates uncertainty about
the actual effectiveness of research findings and its applicability to patients outside of the medical trial.
Racial/ethnic minorities, the elderly and women are disproportionately underrepresented in
clinical trials. Racial and ethnic minorities are barely visible within the patient population in clinical trials
despite having a greater disease burden. “Racial and minority groups… in the USA are disproportionately
affected by a variety of health conditions such as type II diabetes, mellitus, cardiovascular disease, stroke,
HIV/AIDS, and some types of cancer” (Amorrortu et al). For example, in America, where Asians
represent 6 percent of the population, they account for only 1.7 percent of clinical trial participants. Most
clinical trials reported zero native Americans or Alaskans, who account for 2 percent of the overall
population and tend to respond uniquely to a variety of pharmaceutical treatments (Chen and Wong).
When racial/ethnic minority groups are underrepresented, researchers have limited ability to test the
efficacy and safety of new medical treatments across diverse populations.
Even though the elderly make up the majority of patients using medication to treat chronic
conditions, they have little participation in clinical trials that test out new medications. ​The majority of
trial participants include patients between the ages of 18 to 64 years; however, the elderly (65 years and
older) have the greatest disease burden and are barely represented. “Although two thirds of cancer
patients are older than 65 years, only about 25% of cancer trials enrollees have attained this age”
(Herrera).
The inclusion of racial groups in clinical trials is important to the understanding of different
health trends and genetic makeup of different populations and ethnicities around the world. Scientists
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
must take steps towards greater diversity and inclusion in order to improve clinical trials. Making clinical
trials representative of various populations will help scientists discover the effects of certain treatments
on various subgroups and improve prescription methods. Medicine is by no means a one size fits all field,
especially with the development of more sophisticated technologies the introduction of personalized
medicine. Understanding the varying effects of different drugs on different people will help the medical
field as a whole to increase efficiency, and decrease unnecessary spending due to complications or
ineffective treatments. This can only be done by diversifying clinical trials.
There are a variety of strategies researchers can use to diversify their pool of subjects in clinical
trials. The most important part to including underrepresented groups is to address the barriers to
participation many of them face. Depending on the group, these barriers may be “mistrust of research and
the medical system, perceived harms, costs of participating, patient demographics, availability of
transportation, lack of education about clinical trials, fear, time commitment, and family issues” (Ford).
Many people of color, specifically African Americans and Native American peoples have a severe distrust
of medical trials, due to centuries of abuse. In addition to “payment, travel support, flexible recruitment
hours and locations, provision of food during study visits, and positioning study sites in areas with diverse
residents,” the National Institute of Health can commission researchers or doctors of diverse backgrounds
to conduct studies, because clinical trial participants “prefer studies that include research staff who share
their same culture and with whom they can communicate in their own language” (Oh, et al). Making
changes in the standards of diversity of federally funded clinical trials and strict enforcement of these
standards is a logical first step to ensuring minority groups are adequately studied and ultimately for
improved medical treatments for people all across the country.

Race/Ethnicity:
Since the early 1970’s, study of genetic variation has proven the importance of underlying
biological differences between racial and ethnic subgroups in accounting for discrepancies within
treatment outcomes. While some researchers postulate that environmental factors exert greater influence
than biological ones, it has been repeatedly demonstrated that the primary cause of racial and ethnic
disparities is genetic variation between such subgroups (Amorrortu et al.). A study of 25 randomized
phase III clinical trials by the Southwest Oncology Group (SWOG) found that despite the administration
of “uniform follow-up parameters” and adjustment for disease stage, socioeconomic factors, and known
prognostic variables, “African American patients with breast, prostrate, or ovarian cancer”continued to
display “statistically significant worse overall survival than white patients” (Albain et al.). Because such
trials control for all but genetic factors, the underlying cause of this outcome is known to be biological.
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
The SWOG study outcome was not alone in its findings as “disparities persist even after control for
socioeconomic factors, age, insurance, and access related factors” in the vast majority of clinical trials
(Burroughs et al.). Today, “a decade or more of population genetics research has documented genetic, and
therefore biological, differentiation among the races” (Risch et al.). The effects of such differentiation are
most glaring upon analysis of disease incidence and mortality rates by race.
Cancer rates have been studied with the highest frequency, and thus provide a general picture of
how genetics have played a role in stratifying affected populations. Variance occurs primarily by cancer
site, indicating the influence of site specific genetic differentiation. Stomach, liver, and intrahepatic bile
duct cancers all occur more frequently in Asian American/ Pacific Islander populations while Latinos/
Hispanics suffer most from cancer of the cervix. Meanwhile, African Americans “have the highest death
rate from all cancer sites combined and from malignancies of the lung and bronchus, colon and rectum,
female breast, prostate, and cervix of all racial or ethnic groups in the United States” (Ward et al.). These
general racial labels, however, do not sufficiently cover the potential for genetic variance by subgroup.
Despite the fact that Asian American/ Pacific Islander populations are categorized as one block,
vietnamese women are diagnosed with invasive cervical cancer four times more than all other members of
this group, indicating that genetic differences occur on minute levels within identified subpopulations
(Ward et al.). Genetic differences accounting for incidence and response to disease are far more nuanced
than categorical definitions imply. In order for their proper understanding, study of common and
consequential polymorphisms by race is vital (Amorrortu et al.).
Influential genetic differences by race and ethnicity are primarily the result of single-nucleotide
polymorphisms (Albain et al.). Polymorphisms refer to “naturally occurring variants in the structures of
genes and the products they encode” (Burroughs et al.). Today, there exist over 15 million unique
polymorphisms with known implications to drug efficacy (Gomez et al.). The presence or absence of
certain polymorphisms greatly influences prevalence of disease and response to treatment amongst
different groups. Hispanic children, for example, are at lower risk of type 1 diabetes than Caucasian
children due to the lower frequency of the DR3 allele amongst Hispanics. Because DR3 predisposes those
carrying the mutation to type 1 diabetes, Hispanics report lower incidence of the disease than do whites
(Risch et al.). Of greater concern is the ability of polymorphisms to alter drug efficacy by race. Because
observed genetic differences deal primarily with metabolizers, beta blockers, and protein/ enzyme
function, racial variation can alter a drug’s “absorption, distribution, metabolism, and excretion” in
individuals (Burroughs et al.). When different groups present novel polymorphisms, standard drugs may
be rendered ineffective at average dosages. African Americans, who exhibit a particular Apo E
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
polymorphism at a much higher rate than Asians, respond to the medical agent Tacrine far worse than do
Asians, rendering standard dosages ineffective. Even on an external level genetics can impact response to
medication. Such is the case when “skin structure and physiology… affect response to dermatologic and
topically applied products” ("Collection of Race").
Without sufficient consideration of polymorphisms by racial/ethnic subgroup, various
pharmaceutical companies have been responsible for placing ineffective and potentially dangerous
medications on the shelves. Frequently, “unrecognized interactions of tumor biological, hormonal, and/or
inherited host factors… [contribute] to differential survival outcomes by race in sex-specific
malignancies” (Albain et al.). Increased risk and worse outcomes for minorities expand beyond
sex-specific malignancies and into the realm of various disease-specific pharmaceutical drugs. Various
cases against pharmaceutical companies which knowingly sell drugs that function poorly for minorities
have reached federal courts. In 2014, for example, “the state of Hawaii sued Bristol-Myers Squibb Co.
and Sanofi, the manufacturers of the blood thinner Plavix, accusing them of deceptive marketing for
failing to disclose that the drug was less effective for some patients of East Asian or Pacific Islander
descent” (Chen and Wong). For 75% of Pacific Islanders, Plavix is completely ineffective because a
polymorphism within members of this racial group prevents the production of an activation enzyme
(Chen and Wong). Irrespective of potential legal battles and patient health, many pharmaceutical
companies remain ignorant of racial and ethnic differences that make their drugs less effective. Epilepsy
medication Carbamazepine “can cause a severe skin disorder in patients of Asian heritage with a
particular gene variant” (Rathore and Krumholz). Albuterol, one of the most common asthma medications
“doesn’t work as well for African-American and Puerto Rican children as it does for European American
or Mexican children” (Chen and Wong). Asthma incidence rates are nearly double as high amongst
African Americans as amongst whites (Amorrortu et al.).
Generally, flaws in drug efficacy are realized during trial phases and properly adjusted for before
treatments are marketed. Minorities have traditionally been exempt from the ability to reap the benefits of
novel treatments due to systematic underrepresentation in trials. Although African Americans “are more
likely to suffer from respiratory ailments than white Americans… only 1.9 percent of all studies of
respiratory disease included minority subjects, and fewer than 5 percent of NIH funded respiratory
research included racial minorities” (Rathore and Krumholz). Native Americans, who “are at higher risk
of colorectal cancer than white or Asian Americans” were not represented in Taiho Oncology’s 800
participant trial for the colorectal cancer treatment, Lonsurf. A similar trial of 722 participants by Takeda
Pharmaceuticals for novel multiple myeloma (blood cancer) drug Ninlaro included only 13 (1.8% )
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
African Americans. However, “one out of five people diagnosed with multiple myeloma in the U.S. is
black, and African Americans are more than twice as likely as white Americans to be diagnosed with
blood cancer” (Chen and Wong). Lack of diversity is not limited to cancer trials. Racial and ethnic
minorities in America “are disproportionately affected by a variety of health conditions such as type II
diabetes mellitus, cardiovascular disease, stroke, HIV/AIDS, and some types of cancer.” Despite this,
“recent studies in various diseases (e.g., cancer, neurologic diseases, and cardiovascular disease) indicate
that study populations underrepresented the race and ethnicity of those affected by these diseases”
(Amorrortu et al.). Lack of minority representation in trials serves to further subjugate already
disadvantaged groups in America through the denial of adequate and equitable healthcare.
Given the guaranteed existence of genetic polymorphisms known to alter drug efficacy amongst
racial and ethnic subgroups, sufficient study of these variations is vital for the development of functional
pharmaceutical drugs. In medicine, “a 'race-neutral' or 'color-blind' approach to biomedical research is
neither equitable nor advantageous, and would not lead to a reduction of disparities in disease risk or
treatment efficacy between groups” (Risch et al.). Inclusion of minorities in cutting edge clinical research
will benefit entire populations by reducing treatment costs and allowing for the “discovery of therapies of
specific advantage to patients of varied racial and ethnic backgrounds” (Burroughs et al.). Demonstrable
harm results from the perpetual exclusion of minorities from such trials, hindering “the ability to test
efficacy and safety of new treatments” and limiting their generalizability (Amorrortu et al.). In order to
further the goal of individualized treatment, acknowledgement of genetic variation and subsequent
implementation of representative trials is required within the medical community.

Age and Gender:

The elderly have the greatest disease burden and react differently to medical treatments than the
rest of the population, but are still underrepresented in clinical trials. They make up the majority of
patients using medication to treat chronic condition. “Although two thirds of cancer patients are older
than 65 years, only about 25% of cancer trials enrollees have attained this age. Further research indicates
that older adults carry 60% of the national disease burden but represent only 32% of patients in phase II
and III in clinical trials” (Herrera). The majority of of trial patients of between the ages of 18 to 64 years
while ages 65 years are barely visible in clinical trials. Even in medical trials of diseases that
overwhelming affect the older adults, they still lack adequate representation. “Clinical trial participation
of older adults is also low in research on Alzheimer’s disease, arthritis, epilepsy, incontinence, and
cardiovascular disease.” The elderly “suffer the greatest health burden in the Western world, enduring
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
disproportionately high rates of cancer, cardiovascular disease, dementia, arthritis, and Parkinson’s
disease.” They also expend a large part of the money spent on health care as “they spend 36% of total US
personal health care dollars and consume 42% of all prescription drugs" (Herrera). This poor
representation in clinical trials despite high the high disease burden leads to inadequate evidence and
knowledge about the reaction and efficiency of new drugs and treatment on the elderly.
The elderly react differently to medical treatments than the rest of the population and are more
prone to having a dangerous reaction, but their reactions are still ineffectively researched in clinical trials.
Aging greatly impacts responses to drug treatment because it affects the absorption, distribution,
metabolism and excretion of drugs. Changes caused by one’s age, such as an increase in body fat and a
decrease in body water, can influence the volume of distribution of drugs in one’s body. The elderly are
more sensitive to drugs because using a standard dosage may increase plasma concentration and risk of an
adverse reaction. Aging changes “the absorption, distribution, metabolism and excretion of the drugs”
(Shenoy). They are at a higher risk for an adverse drug reaction because of the” pharmacokinetic and
pharmacodynamic changes associated with aging.” According to the 2006 criteria in the Health Plan
Employer and Data Information set, “9.6% of older veterans received at least 1 drug deemed
inappropriate.” In addition to potential dangerous reactions for the elderly, increasing age may cause
“organ abnormalities or lower functional status”. For example, kidney function “may decline in older
adults, impairing drug excretion and metabolic clearance of drugs.” Also, “in older type 2 diabetes
patients, a higher prevalence of comorbidities, tolerance of adverse effects from medication, and changes
in metabolic control requires a modified treatment approach” (Herrera).
Even though adequate representation of the elderly in clinical trials would lead to potentially
life-saving information about their reactions to new drugs and medical treatments, they are poorly
represented in medical trials because of researchers’ age bias. Researchers fear of their drug failure if the
elderly are well represented in clinical trials because of the potential different behavior of their drug
within the elderly population. Research also do not want to deal with the possible need for supportive care
of the elderly. “Biases and ageism manifest as systematic barriers that impede minority elder enrollment
in clinical trials. Health care providers are less likely to refer older ethnic minorities for screening and
treatment, including those provided by clinical trials. A prevalent notion expressed by researchers is that
older adults are less willing to participate in clinical trials than are younger adults (Herrera).
The underrepresentation of the elderly also goes beyond blaming the researchers running the
clinical trials. In some cases there are even protocol restrictions that exclude certain age criteria. Federal
laws require the representation of women and minorities in cancer trials; however, there is no law
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
ensuring the representation of the elderly​.
The elderly are more likely to experience financial issues, physical problems and poor
communication about clinical trials, which makes it more difficult for them to enroll. Older adults face
“economic constraints, underinsurance, lack of insurance, communication issues (e.g., hearing difficulties
that interfere with telephone interviews and impaired vision that affects written surveys) and physical
immobility that constrains transportation options,” which creates challenges for them to participate in
clinical trials (Herrera).
Despite composing fifty percent of the total worldwide population, women are poorly represented
in clinical trials studying new medicine. “A study that evaluated the inclusion and analysis of sex in the
results of federally-funded randomized clinical trials in nine major medical journals in 2009, researchers
found most studies that were not sex-specific had an average enrollment of 37% women. Government
reports in the 1980s and early 1990s found ‘that women were lacking representation in federally funded
studies and certain diseases affecting both sexes” (Liu and Mager).
Men and women respond to medical treatments differently due to their biological differences, so
it is imperative to adequately include women in medical trial to understand how they will react to new
drugs or treatment. They may have different patient outcomes of responses to treatment. “There are
differences in the physiology of the sexes that may translate into differences in pharmacokinetics and/or
pharmacodynamics for specific drugs”. The sex differences between men and women can be observed in
various disease states: “prevalence, diagnosis, severity and outcomes.” There are certain disease states
that overwhelmingly affect women. It is important to determine is these sex differences in clinical trials as
it may result in “differences in safety or efficacy of prescription products between men and women” (Liu
and Mager).
Women lack adequate representation in clinical trials because of researchers’ biases against
female participation. There is often a false notion among researchers that women have the same response
to medicines. Researchers do not want women in their clinical trials because they “viewed women as
confounding and more expensive test subjects because of their fluctuating hormone levels” (Liu and
Mager).

Causes, Implications, and Solutions for Lack of Diversity in Clinical Trials:

There are many complicated and multidimensional causes for the lack of diversity in clinical
trials. The first and most overt cause is the lack of opportunity for participation of traditionally
underrepresented groups. This lack of opportunity can be caused by different factors depending on each
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
individual’s situation. Some minority groups, however, experience similar barriers to participation that are
caused by their minority status. An extensive review of literature conducted by researchers at Johns
Hopkins University found “an association between lack of opportunity and reduced participation in trials”
and “an association between specific sociodemographic characteristics, such as older age, socioeconomic
status, and racial/ethnic minority status, along with lack/inadequate health insurance and reduced
enrollment” (Ford et. al). Barriers to participation for medical trials often only apply to minority groups.
For example, “patients in households making less than $50,000 per year were 27 percent less likely to
participate in trials. The African American median household income in 2017 was about $40,000,
compared with $68,000 for non-Hispanic white Americans” (Burke). In addition, many people cite
logistical challenges, financial burdens, and lingering distrust from past victimization in medical
experiments as barriers to participation, hardships that disproportionately affect minorities (Burke). The
most frequently reported barriers to participation from clinical trials are “mistrust of research and the
medical system, perceived harms, costs of participating, patient demographics, availability of
transportation, lack of education about clinical trials, fear, time commitment, and family issues” (Ford et.
al). Many of these barriers to participation are specific to certain age groups or racial groups. For
example, African Americans and Native Americans are more likely to have mistrust of the medical
system because of the long history of abuse and unethical medical experiments done by white doctors
throughout the 19th and 20th centuries. The elderly are more likely to not have access to transportation
because a higher percentage are unable to drive.
Past efforts to increase minority enrollment in clinical trials have been failures. The Revitalization
Act, passed in 1994, required inclusion of diverse groups in all studies funded by the National Institutes of
Health. In conducting or supporting clinical research the Director of NIH was required to ensure that
women were included as subjects in each project of such research, as well as members of minority groups.
Although this appears to be a beneficial policy, in practice it has not been effective. According to a report
by researchers at the Yale School of Medicine on participation in cancer trials, “although the trial
enrollment rate increased by almost 50% during 1996 through 2002, the proportion of trial participants
who were not white actually declined during this period,” even after accounting for cancer type, age, and
sex (Murthy, et al). Policies like the Revitalization Act are a step forward for diversity and inclusion into
clinical trials, but little progress has been made to actually incorporate diversity into clinical trials.
The second cause for the lingering disparities in participation rates in clinical trials is the lack of
funding for minority-led research. Clinical trials led by minority researchers are more likely to include a
more diverse group of people, and are also more likely to focus solely on underrepresented groups.
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
However, minority doctors are also significantly underrepresented in the medical and scientific
communities. For example, “blacks or African Americans and Hispanics, respectively, represented only
4.3% and 7.2% of doctorate degree awardees in biomedical sciences in 2013, although they represented
13.9% and 17.2% of the US population during the same period. Moreover, less than 2% of NIH principal
investigators on research project grants are black” and there are similar disparities for Hispanic and Asian
researchers (Oh et. al). In addition, “an NIH study of research grant awards found that the proportion of
applications funded was 13% lower for blacks or African Americans and 4% lower for Asians than
among whites” (Oh et. al). The root of the problem for the underrepresentation of minorities in the
medical community is due to a more complex system of racism and unequal opportunity for minorities,
and is a problem which will take many decades to unravel and solve. The funding aspect of this problem,
however, is something that can be solved more easily. There is a consistent reviewer bias in peer reviews
for studies conducted by minority scholars. These studies receive lower scores by peer reviewers and
therefore are less likely to get adequate funding. Reforms in procedures for funding minority led studies
as well as changes in peer review systems are necessary to aid in closing the funding gap for minority
researchers.
The third main cause of lack of diversity in clinical trials is not enough emphasis on including
underrepresented groups in studies. There is no incentive to include a diverse pool or participants, nor is
there a push from the National Institutes of Health, pharmaceutical companies, or other doctors to include
an adequate number of minorities in clinical trials. There are no large scale efforts to recruit people of
underrepresented groups, and there are no campaigns advertising the existence of these studies. According
to a group of researchers from the University of California in San Francisco, “few US biomedical studies
focus recruitment efforts on attaining adequate minority representation, nor do they focus their research
attention to factors most relevant to minority health… Moreover, less than 5% of NIH-funded respiratory
research reported inclusion of racial/ethnic minorities” (Oh et. al). This illustrates the complete failure of
the Revitalization Act and the inadequacy of NIH to enforce its own rules. Because of this, policies such
as the Revitalization Act are seen as mere stunts to put up a front of diversity and inclusion when in
reality methods of choosing participants go unchanged. These three factors are the main causes of the vast
underrepresentation of certain minority groups as well as women and the elderly in clinical trials. Quick
and deliberate action must be taken in order to ensure the inclusion of these groups in clinical trials, as it
benefits not only their health, but the health of the nation overall as well.
In this comprehensive review of literature, we have talked about the importance of ensuring
proper representation of different races in clinical trials, as well as a variety of ages and sexes, but some
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
may be left wondering how big of an impact this diversity actually makes on the lives and well being on
people across the nation. Diversifying medical trials and accumulating data on various subgroups of the
American population will improve the health of the many groups that are ignored by clinical trials, the
vast majority being minorities, which means a large number of low income families will be affected. This
new collection of data will also aid doctors and hospitals in prescribing the correct medicines and the
correct amount of medicine to patients. This will increase efficiency in hospitals by cutting out the time it
would take to address complications with any ineffective treatments, as well as lowering costs for not
only hospitals but patients as well by eliminating additional costs of ineffective medicines but also costs
for additional time spent in hospitals and additional costs for treatments used to aid in any complications
that come with incompetent medicine or medicine that has negative side effects.
There are a variety of ways to increase diversity in clinical trials, on all levels of the process. The
most straightforward way is to give minority groups and underrepresented population easier access to
clinical trials, and to accomodate for any hardships people of these groups may have. For example,
“challenges of transportation, childcare, work hour considerations, and meals can be addressed via
payment, travel support, flexible recruitment hours and locations, provision of food during study visits,
and positioning study sites in areas with diverse residents” and “to compensate for the limited internal
referral base, tertiary care centers can partner with community health care providers. Targeted advertising
can reach potential participants at a moderate cost” (Oh et. al). In addition, it could be beneficial to
“design trials specifically to address clinical subgroups in instances when differences in presentation,
prognosis, and response to therapy have been suggested by preliminary data” (Burke). These
accommodations may cost money upfront, but will save money and efficiency in the long run.
The second way to increase trial diversity would be to remodel the appropriations and grants
system for clinical trials, especially those led by minority researchers or of studies specifically designed
for people of color, the elderly, or children. This tactic may be more difficult to achieve and perfect than
accommodating for marginalized groups in clinical trials as it deals partially with more deep rooted
systemic bias, but nonetheless it is necessary in order to diversity the pool of clinical trial participants and
important to the collection of medical data for minorities.
The third and final tactic that can be used to promote diversity and inclusion in clinical trials is by
changing existing policy. Government policy could be changed to only provide funding for studies that
meet stricter standards of diversity. Strict enforcement of these new standards would be key to achieving
success, as “since the passage of Revitalization Act in 1993, less than 2% of more than 10,000 cancer
clinical trials funded by the National Cancer Institute included enough minority participants to meet the
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
NIH’s own criteria and goals” (Oh, et al). And according to Chelsea Burke, an expert Laboratory
Technician and Clinical Study Coordinator, “biopharma companies aren’t likely to focus on minority
recruitment unless the government pressures them to do so.” Implementing higher standards for clinical
trial diversity would encourage researchers to diversify the participants in their studies in order to receive
federal funding. This, of course, would positively affect millions of people across America.

Conclusion
The lack of diversity in clinical trials has been a long occurring problem. Racial and ethnic
minorities, women and the elderly are greatly underrepresented. As minority groups, they are already
disadvantaged in terms of adequate health care access, and their under representation in clinical trials only
exacerbates the problem. They often have different biological and genetic differences than the rest of the
population, so they will have different reactions to medical treatments The exclusion of these subgroups
from clinical trials is dangerous and unethical given their unique and potentially adverse reactions to new
medical treatments. If a medication is placed on the shelves with a label vouching for its “safety,” it
should be equally as safe for all members of the population. Such a label may not be rightfully placed on
any product which has not been adequately tested upon all segments of the population.
Unfounded fears of higher cost, slower treatments, and perpetuated social oppression have
allowed pharmaceutical companies and doctors alike to turn a blind eye to the pressing need for diverse
trial participation. By clinging to these doubts, drug producers have increased overall treatment costs for
minorities, slowed the development of universally useable drugs, and further subjugated minority groups
by denying to provide them with equitable health care opportunities. The safety and efficacy of medical
drugs and treatments can be ensured for all people through diversity requirements, easy access to clinical
trial opportunities for minority groups and education programs for medical researchers about the
importance of diversity in clinical trials. Having real diversity in clinical trials will not only benefit
minority groups, but help all people no matter their background through extensive research about the true
side effects of new drugs. With public health at risk, the implementation of such regulation cannot be
further delayed.
 Uma Gupta
Mira Diamond-Berman
Melina Worthington

Works Cited

Albain, Kathy S., et al. "Racial Disparities in Cancer Survival among Randomized Clinical Trials Patients

of the Southwest Oncology Group." ​Journal of the National Cancer Institute,​ vol. 101, no. 14, 15

July 2009, pp. 984-92, doi:10.1093/jnci/djp175. Accessed 21 Apr. 2019.

Amorrortu, Rossybelle R., et al. "Recruitment of racial and ethnic minorities to clinical trials conducted

within specialty clinics: an intervention mapping approach." US National Library of Medicine, 17

Feb. 2018, doi:10.1186/s13063-018-2507-9. Accessed 16 Apr. 2019.

Burroughs, Valentine J., et al. "Racial and Ethnic Differences in Response to Medicines: Towards

Individualized Pharmaceutical Treatment." Journal of the National Medical Association, vol. 94,

no. 10, Oct. 2002, pp. 1-27, www.ncbi.nlm.nih.gov/pmc/articles/PMC2594139/.

Chen, Caroline, and Riley Wong. "Black Patients Miss out on Promising Cancer Drugs." ​ProPublica​, 19

Sept. 2018, www.propublica.org/article/black-patients-miss-out-on-promising-cancer-drugs.

Accessed 10 Apr. 2019.

"Clinical Trial Diversification." ​TransCelerate,​ Biopharma,

www.transceleratebiopharmainc.com/initiatives/clinical-trial-diversification/. Accessed 20 Apr.

2019.

"Clinical Trials Have Far Too Little Racial and Ethnic Diversity." ​Scientific American,​ 1 Sept. 2018,

www.scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/.

Accessed 23 Apr. 2019.

Coakley, Meghan, et al. "Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging

Women and Minorities in Clinical Trials." ​Journal of Women's Health,​ vol. 21, no. 7, July 2012,

doi:10.1089/jwh.2012.3733. Accessed 20 Apr. 2019.

 Uma Gupta
Mira Diamond-Berman
Melina Worthington
"Collection of Race and Ethnicity Data in Clinical Trials." Food and Drug Administration, 26 Oct. 2016,

www.fda.gov/downloads/regulatoryinformation/guidances/ucm126396.pdf. Accessed 16 Apr.

2019.

Corbie-Smith, Giselle, et al. "Adequacy of reporting race/ethnicity in clinical trials in areas of health

disparities." ​Journal of Clinical Epidemiology,​ vol. 56, no. 5, May 2003, pp. 416-20,

doi:10.1016/S0895-4356(03)00031-3. Accessed 22 Apr. 2019.

Correa-de-Araujo, Rosaly. "Serious Gaps: How the Lack of Sex/Gender-Based Research Impairs Health."

Journal of Women's Health​, vol. 15, no. 10, 2 Jan. 2007, doi:10.1089/jwh.2006.15.1116.

Accessed 17 Apr. 2019.

Davio, Kelly. "In the Effort to Diversify Clinical Trials, Trust, Access, and Education Play Crucial

Roles." ​AJMC Managed Networks,​ 5 Sept. 2018,

www.ajmc.com/focus-of-the-week/in-the-effort-to-diversify-clinical-trials-trust-access-and-educa

tion-play-crucial-roles///?p=2. Accessed 24 Apr. 2019.

Ford, Jean G., et al. "Barriers to Recruiting Underrepresented Populations to Cancer Clinical Trials: A

Systematic Review." Cancer, vol. 112, no. 2, 2008, pp. 228–242. Wiley.com,

doi:10.1002/cncr.23157.

Gomez, Scarlett, et al. "The Importance of Race and Ethnic Background in Biomedical Research and

Clinical Practice." The New England Journal of Medicine, 20 Mar. 2003,

s3.amazonaws.com/academia.edu.documents/41604029/The_Importance_of_Race_and_Ethnic_

Backgr20160126-12158-16hswor.pdfAWSAccessKeyId=AKIAIWOWYYGZ2Y53UL3A&Expir

es=1554485073&Signature=Zc9ZMgzWOz9KWm1ZeiW5lzZngyc%3D&response-content-dispo

sition=inline%3B%20filename%3DThe_Importance_of_Race_and_Ethnic_Backgr.pdf. Accessed

7 Apr. 2019.
 Uma Gupta
Mira Diamond-Berman
Melina Worthington
Gorelick,, Philip B., et al. "The Recruitment Triangle: Reasons Why African Americans Enroll, Refuse to

Enroll, or Voluntarily Withdrawal from a Clinical Trial." ​Journal of the National Medical

Association,​ vol. 90, no. 3,

www.ncbi.nlm.nih.gov/pmc/articles/PMC2608331/pdf/jnma00361-0021.pdf. Accessed 23 Apr.

2019.

Grady, Denise. "In Cancer Trials, Minorities Face Extra Hurdles." ​The New York Times,​ 23 Dec. 2016,

www.nytimes.com/2016/12/23/health/cancer-trials-immunotherapy.html?_r=0. Accessed 18 Apr.

2019.

Hamel, Lauren M., et al. "Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients

with Cancer." ​Cancer Control​, vol. 23, no. 4, Oct. 2016, doi:10.1177/107327481602300404.

Accessed 23 Apr. 2019.

Herrera, Angelica P., et al. "Disparate Inclusion of Older Adults in Clinical Trials: Priorities and

Opportunities for Policy and Practice Change." ​Am J Public Health​, vol. 100, no. 1, Apr. 2010,

doi:10.2105/AJPH.2009.162982. Accessed 18 Apr. 2019.

Liu, Katherine A., and Natalie A. Dipietro Mager. "Women's Involvement in Clinical Trials: Historical

Perspective and Future Implications." Pharmacy Practice, vol. 14, no. 1, 2016.

Murthy, Vivek H., et al. "Participation in Cancer Clinical Trials Race-, Sex-, and Age-Based Disparities."

Jama​, 9 June 2004, doi:10.1001/jama.291.22.2720. Accessed 22 Mar. 2019.

Oh, Sam S., et al. "Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled." PLOS

Medicine, vol. 12, no. 12, 2015, doi:10.1371/journal.pmed.1001918.

Rathore, Saif S., and Harlan M. Krumholz. "Race, ethnic group, and clinical research." National Institutes

of Health, doi:10.1136/bmj.327.7418.763.Accessed 16 Apr. 2019

Risch, Neil, et al. "Categorization of humans in biomedical research: genes, race and disease." Genome

Biology. Genome Biology,

 Uma Gupta
Mira Diamond-Berman
Melina Worthington
genomebiology.biomedcentral.com/articles/10.1186/gb-2002-3-7-comment2007.Accessed 7 Apr.

2019

Shenoy, Premnath, and Anand Harugeri. "Elderly Patients' Participation in Clinical Trials." Perspectives

in Clinical Research, vol. 6, no. 4, 2015, p. 184

Valtierra, Lisa. "We Need to Talk about Race: Lack of Diversity in Clinical Trials Is a Public Health

Issue." ​Clinical Trials Arena​, 13 June 2018,

www.clinicaltrialsarena.com/comment/we-need-to-talk-about-race-lack-of-diversity-in-clinical-tri

als-is-a-public-health-issue-6204607-2/. Accessed 3 Apr. 2019.

Ward, Elizabeth, et al. "Cancer Disparities by Race/Ethnicity and Socioeconomic Status." ​CA: A Cancer

Journal for Clinicians​, vol. 54, no. 6, 31 Dec. 2008, doi:10.3322/canjclin.54.2.78. Accessed 22

Apr. 2019.

Weidman Burke, Chelsea. "The Importance of Diversity in Clinical Trials (Because Right Now, It's

Lacking)." ​BioSpace​, 10 Oct. 2018,

www.biospace.com/article/the-importance-of-diversity-in-clinical-trials-because-right-now-it-s-la

cking-/. Accessed 17 Mar. 2019.

Weiler, Nicholas. "Genomic Analysis Reveals Why Asthma Inhalers Fail Minority Children." ​University

of California San Francisco​, 14 Mar. 2018,

www.ucsf.edu/news/2018/03/410041/genomic-analysis-reveals-why-asthma-inhalers-fail-minorit

y-children. Accessed 13 Apr. 2019.