Addressing Underrepresentation of Minority Women in Clinical Trials

This project prospectus reviews the underrepresentation of minority women in breast cancer clinical trials and biospecimen banks. It highlights the problem statement, noting disparities in breast cancer survivorship among minority women compared to Caucasian women, potentially linked to underrepresentation in research. The purpose is to understand the relationship between this underrepresentation and potential biases in research outcomes. The study aims to use a quantitative research design to address this issue, exploring the impact of education and barrier removal on participation rates. Data will be collected through surveys, and limitations include the narrow scope and personal nature of the topic. The health belief model guides the study, examining perceived threats and efficacy of health behaviors influencing participation. Desklib provides access to similar projects and study resources.

RUNNING HEAD: SOCIOECONOMIC STATUS, OBESITY AND BREAST CANCER
I am glad to have the opportunity to review your prospectus again. As you know, my job as
prospectus reviewer for the Program Director is to ensure that your proposed research fits within
the discipline, is a doctoral-level study, and is feasible to complete. Given this, I can’t quite
recommend approval of your prospectus at this time.
First, I reviewed this as a first submission because the main study changed completely. I would
really like to encourage you to go back to the second submission and revise instead of continuing
with this one unless you can come up with a succinct quantitative method and data for this topic.
Right now, this prospectus lacks focus and it is not clear what methods you will use or why.
In case you decide to continue with this topic I have provided some feedback. My concerns impact
some of the rubric criteria. The main concern is that this study is currently not feasible because you
do not have a specific methodology. Remember that course work for students in the Epidemiology
specialization focus on quantitative methods and Epi students are really encouraged and learn the
skills to do quantitative studies. Another concern is the problem statement does not yet contain any
identification of or argument for, the specific research gap being addressed in the study. Another
concern is the lack of alignment. The problem statement, framework, and research questions are
not aligned. Once you revise the problem statement, be sure the research questions and theoretical
framework align.
I have provided comments using the Comments feature in Word as well as Track Changes in the
document below. Please make sure you are viewing the document in software where the comments
can be seen (e.g., do not use Google Chrome). The comments that particularly relate to the rubric
criteria are highlighted in yellow.
Please don’t hesitate to have your chair contact me with any questions or concerns. I look forward
to seeing your revisions!
Kind regards,
Underrepresentation of Minority Women in Breast Cancer Clinical Trials and Biospecimen
Banks
Walden University

Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks 2
Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks regarding
Breast Cancer
Problem Statement
According to the Centers of Disease Control and Prevention (CDC), breast cancer is the
most common form of cancer in women in the United States (CDC, 2019). However, breast
cancer is the leading cause of death for Hispanic women and the second leading cause of death
among white, black, Asian/Pacific Islander, and American Indian/Alaskan Native women (CDC,
2019). Although breast cancer continues to pose a significant threat to women’s health, fatalities
amongst women with breast cancer have decreased within the United States (WHO, 2019).
Although there have been advancements in the treatment that is being provided to the
patients suffering from cancer, there have been several discrepancies in survivorship among
minority women when compared to Caucasian counterparts (da Costa Vieira et al., 2017).
According to World Health Organization, advancements have been observed in early detection
of cancer by efficient cancer screening programs (WHO, 2019). However, discrepancies are
majorly attributed to lack of access to quality healthcare, overall poorer health practices and
mistrust of the healthcare professionals (de Costa Viera et al., 2017). According to Frierson et al.,
(2017), African – American women have a much higher survivability rate than Caucasian
women. The discrepancy that has been caused due to the different races of the individuals have
been regarded as the Black – White crossover. More recently, however, these historic
explanations of higher cancer morbidity are increasingly viewed as incomplete (Banegas et al.,
2016; de Costa Viera et al., 2017; DeSantis et al., 2016; Hines et al, 2017). An emerging novel
explanation for the difference in breast cancer survivorship may be dependent on the
representation of women of minority groups in both clinical trials and within biospecimen banks
(Banegas et al., 2016). There is a decrease in the number of participants in the clinical trials from

Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks 3
the minority group which can create a gap in the research studies. The discrepancy by the
different race of the individual gives rise to the populace participating less in the research.
Because of this, there is a possibility of exclusion of valuable information needed to understand
the discrepancies between the minority women and the Caucasian women (Banegas et al., 2016;
Breitkopf et al., 2017; Duma et al., 2017).
Purpose
The primary aim of the study is to understand the relationship between the
underrepresentation of minority women in clinical trials as well as bio specimen banks. There is
a possibility of biasness in the results while conducting research on the clinical trials and bio
specimen banks. The design of the study that will be implemented for this research is
quantitative research. For an effective understanding of the research study, addressing the
underrepresentation of the minority women is important in clinical trials as well as bio specimen
banks. According to the study conducted by Friedman et al., (2015), few studies have been
conducted encircling the minority population with major health disparities faced by the
community with less percentage of patients enrolling in the clinical trials. Hence, this paper will
help in understanding the reason for this occurrence.
Significance
The results of this study will provide a more definitive correlation between the
underrepresentation of minority women in clinical trials and biospecimen banks and differences
in breast cancer survivorship. Insights from this study may guide health practitioners, breast
cancer organizations, and women towards developing more inclusive clinical trials and initiatives
for the increased collection of biological specimens from minority women with breast cancer.
With increased representation, clinical trials and breast cancer research may be able to focus

Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks 4
more on the expression of breast cancer in minority women and increase overall breast cancer
survivorship.
Background
1. DeSantis et al., (2015) researched on breast cancer statistics to understand its
survival, incidence, screening and mortality. A decrease in the death rates among all
ethnic groups and an increase in the incidence rate of black women were observed.
Disparity in the mortality rates of the black and white women in the research study
have been observed to be increasing as was suggested.
2. Frierson et al., (2017) conducted a study that was primarily based on the
identification of the motivating factors which would be required to increase the
participation of minority women in cancer research. It was observed during the
evaluation that racial concordance was the major factor that drives the low
participation of these women.
3. Amorrortu et al., (2018) used intervention mapping as a recruitment procedure by the
program coordinators to include a diverse class of population in clinical trials
conducted for the research. It was found in their results that the program is a very
time-consuming procedure to be implemented in the study. It was also observed that
to make the plan a success, the program coordinators has to interact with the minority
population which was not executed. Hence, it was suggested that the program
investigators need to be familiarized with the procedure and then only should be
implemented in a bigger population.

Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks 5
4. Benegas et al. (2016) requested information and biospecimen donations by 140
Hispanic women with participants consent by the patient’s physician or a research
assistant. Consent rates were high (97.1% and 92.9% in the physician and research
assistant arms, respectively) and not different between minority women or Caucasian
women. Findings of Benegas et al (2016) is consistent with emerging literature, that
perceptions of Hispanics’ unwillingness to participate in biospecimen sharing for
research are not supported by existing data.
5. Duma et al (2017) looked at 1012 clinical trials related to cancer clinical trials.
Researchers found a decrease in recruitment of minorities over the past 14 years. This
decrease illustrates dissonance with historical data. African Americans, Hispanics,
and women were less likely to be enrolled in cancer clinical trials overall. Duma et al
(2017) also suggested that future trials should take extra measures to recruit
participants that adequately represent the US cancer population.
Theoretical Framework /Behavioral Model
As this study will focus on the interaction between minority women and clinical
researchers in regard to representation, this study will be guided by the health belief model. The
health belief model states that a person’s perceived threat of disease coupled with the efficacy of
a given health behavior determines whether the person will participate in health behaviors
(Skinner, Tiro & Champion, 2015). Within the context of this study, this behavioral model will
help explain why minority women may or may not abstain from participation in breast cancer
clinical trials and biospecimen sharing.
Research Question(s) and Hypotheses (if applicable)

Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks 6
RQ1: What impact will educating the minority women about the inclusion of them in research
studies have on the rate of clinical trials and bio specimen bank studies?
RQ2: What will be the effect of not including the minority women in cancer research studies like
clinical trial and bio specimen banks?
RQ3: Will the participation rate improve when the factors which act as barriers will be
eliminated from the scenario?
RQ4: What can be done to better represent minority women in breast cancer biospecimen
sharing?
Nature of the Study
The nature of this study to be conducted is a quantitative study design. Quantitative
research study was selected because of its inclusion of statistical and computational methods in
the efficient analysis of the observed occurrences. The study will be conducted on two groups for
the two variables which as factors in influencing the participation of the minority women. After
the tabulation of the data, a mathematical analysis is carried out to understand the relationship
among the two factors.
Possible Types and Sources of Data
For an effective quantitative research of the study, the possible sources of data that can be
obtained by surveys conducted on the participants. The survey can include interviews,
questionnaires or polls to understand the behavior of the participants towards the disparities that
have been faced by them. It can also help in understanding the hesitation of the minority people
towards active participation in clinical trials and bio specimen sharing. Conducting surveys are
an useful approach when features of a group or their behavior need to be explained.

Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks 7
Limitations, Challenges, and/or Barriers
A limitation of this study is the narrow scope of the inquiry. Although the literature does
exist exploring the phenomenon of underrepresentation of minority women in breast cancer
clinical trials and biospecimen sharing, the amount of literature is indicated to be small by other
researchers. Additionally, this topic may be difficult to study as reasons for abstaining from
breast cancer clinical trials and biospecimen sharing can be personal and private.

Underrepresentation of Minority Women in Clinical Trials and Biospecimen Banks 8
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