The National Black Church Initiative (NBCI) and the American Clinical Health Disparities Commission welcome pharmaceutical partners and their diversity efforts toward improving the participation of African-Americans and Latinos in clinical trials. Such collaboration serves as a mechanism to enhance the level of education for African-Americans and Latinos needed to make informed decisions. Thus, with over 35 years of patient education, health promotion, and clinical trials recruitment, NBCI has put forth one of the most innovative initiatives focusing on the inclusion of African-Americans and Latinos in clinical trials.

General Overview

The National Black Church Initiative (NBCI), a coalition of 150,000 African-American and Latino Churches with 27.7 million members, seeks to eradicate racial disparities in healthcare, technology, education, housing, and the environment. The mission of the NBCI is to provide critical wellness information to its members and the broader public using faith-based, out-of-the-box, cutting-edge solutions to address economic and social issues. Our solutions are backed by statistical analysis, science-based strategies and techniques, and methods that have been proven to be effective and efficient.

To that end, NBCI is launching an innovative, science-based clinical strategic plan to promote clinical trials among traditionally underrepresented groups of African-Americans and Latinos. The NBCI National Clinical Trials Strategic Plan (NCTSP) is a comprehensive program poised to enhance the understanding, education, and participation of African-Americans and Latinos and thereby address the disproportionate representation of African-Americans and Latinos in clinical trials.

Particularly given documented medical abuses of African-Americans involved in the historic Tuskegee Experiment and Henrietta Lacks and others, the NCTSP engages access to 27.7 million African-Americans and Latinos with integrity, confidentiality, and health standards-based protocols. Increasing the involvement of African-Americans and Latinos within clinical trials serves as a conduit for improving the long-term effectiveness of medical prescriptions and treatments to combat leading chronic diseases (i.e. COVID, cancer, heart disease, stroke, diabetes).

Goal and Objectives of NCTSP

The overarching goal of the NBCI National Clinical Trials Strategic Plan is to increase the number of African-Americans and Latinos participating in clinical trials involving leading chronic diseases throughout the United States.

Three main objectives have been identified to implement the goal:

1. Collect medical historical data on African-Americans and Latinos who comprise NBCI constituencies.
2. Create broad-based educational clinical trials program among our 150,000 churches and online platforms, including social media.
3. Cultivate the health knowledge and understanding of African-Americans and Latinos through experts in the field and partners from the National Medical Association and the National Hispanic Medical Association.

The Need for NCTSP

“Many illnesses such as sickle cell anemia, asthma, diabetes, heart disease, HIV/AIDS, and certain kinds of cancer, such as prostate cancer, affect African-Americans more than other people. Yet, little is known about how they respond to treatment, so African-American volunteers are needed to help scientists learn how different treatments affect them. When African-Americans take part in clinical trials, they help improve the health of all people and provide greater understanding of health disparities.”
The Center for Information and Study on Clinical Research Participation, 2016

The disproportionate representation of African-Americans and Latinos in national clinical trials is alarmingly disturbing. Both historic and current trends have continuously revealed how the inadequate representation of African-Americans and Latinos within these clinical trials can result in adverse effects given the absence or lack of the diversification of the population served (Tigerlilly Foundation, 2022; Food Drug Administration, 2022).

One historic trend, particularly as unique to the Tuskegee Study of Untreated Syphilis, has cultivated doubt into the minds of African-Americans given the unethical and unforgiveable treatment and participation of African-American men in this particular clinical trial. Another historic trend as unique to the Henrietta Lacks and the non-consensual agreement of the removal of cells from an African-American female. The implications of these unfortunate historic occurrences and other similarly situated occurrences combined with the present participation rates of 3.1% of African-Americans in clinical trials, as highlighted by the American Journal of Managed Care (2019) in clinical trials, have encouraged consideration of ways to move forward regarding these critical issues. The Journal of Clinical and Translational Science (2021), too, report the historic low trends of Latinos in the clinical trial studies. The study focuses on integrated approach of utilizing both researchers and volunteers in this concerted effort.

To that end, in 2022, both the African-American and Latinos community have significant choices as it stands at the crossroads of overarching risk and benefits of health and wellness. The first choice is to continue ignoring the health issues that impact the African-American and Latino communities daily while remembering the historic patterns of clinical trial abuse. Sadly, the first choice is incomplete of the consideration of the plethora of health and wellness issues affecting African-Americans and Latinos. The second choice is to fight back by remembering the lessons learned from these medical abuses, changing the approach and cultural attitude toward clinical trials to generate the best possible outcomes in health disparities. The second choice is more acceptable, particularly given how the level of responsiveness and proactiveness will allow us to engage the issue in a more systematic way and utilize governmental resources and pharmaceutical industry as collaborative partners.

To that end, NBCI chooses to engage the involvement of Blacks and Latinos in clinical trials in a strategic and focused manner. The uniqueness of the NCTSP is that the leadership is not coming from the federal government, a pharmaceutical company, a predominantly white institution, or any other minority medical group or organization. The NCTSP is situated within a faith-based organization where a moral ethos and authority exists to support guiding and moving the needle forward for enhanced health outcomes for African-American and Latino community.

Our approach is one that is not top-down by telling our membership what is good for them. This is a huge game-changer for informing African-American and Latino communities in a more inclusive and intentional manner. And because the black church recognizes the powerful benefits of clinical trials and the impact they could have on health outcomes and eradicating health disparities, it becomes imperative to engage in this type of comprehensive approach.

NBCI Health Emergency Declaration (HED)

Twenty-five years ago, NBCI launched the Health Emergency Declaration (HED) which underscored how African-Americans continue to be in a health emergency. The HED prioritizes awareness of the importance of quality health and wellness and the need to be intentional about how those matters are address.

According to health statical data, as published in 2020, African-Americans continue to have the highest mortality rate for all cancers combined compared with other racial and ethnic groups. In addition, other leading causes of death for African-Americans include heart disease and complications from obesity that, too, have implications that cannot be denied. While NBCI provides our congregations with accurate health information and culturally sensitive literature as well as advocate the use of pre-screening tests, encourage data collection, and create protocols that emerges from the COVID-19 pandemic, fast forward to today, our health status has not improved since the launch of NBCI's HED.

After eleven years of HED, our NBCI clinical staff has concluded the need to raise the bar in African-American health outcomes. Our NCBI clinical staff has also concluded the need to not only emphasize participation in clinical trials, but also the need to have faith-based communities advocate for the use of clinical trials. NBCI realizes the importance of having the voice of the faith-based community to be involved in efforts toward leading and strengthening the delivery, structure, and sustainability of health and wellness for African-Americans and Latinos. Doing so can bring dramatic increases in African-American and Latino participation in clinical trials which can lead to positive health outcomes in these communities, particularly given the membership of NBCI as consisting of 27.7 million African-American members plus the millions of Latino faith-based members as the foundation of our plan. These communities constitute 109 million individuals which, in effect, cover one-third of the country.

NBCI’s Clinical Trials Education, Awareness, and Participation Program (CTEAPP)

The mission of the NBCI clinical trials program is to increase the representation of African-Americans in clinical trials. African-Americans' participation in clinical trials helps ensure that our population receives the benefits of cutting-edge drug therapies and modern medicine. NBCI always has and will continue to hold itself to the highest ethical standards while advocating clinical trials participation in our faith-based communities.

Launched eight years ago, NBCI's big step toward advocacy for clinical trials in the African-American community is launching and facilitating the NBCI Clinical Trials Education, Awareness, and Participation Program (CTEAPP). CTEAPP, a groundbreaking initiative housed under NBCI's Health Emergency Declaration (HED), is a critical component of our work in eliminating health disparities through participation in clinical trials.

NBCI seeks to educate its member churches and congregants of the value, benefits, protections, and promises clinical trials can offer participants. In doing so, NBCI will be assured of the protections and safeguards of clinical trial protocols.

Therefore, we have adopted a set of five core principles that will govern our decisions regarding involvement in the NBCI NCTSP:

Principle 1

NBCI promotes education and awareness as vital components in getting Blacks to participate in clinical trials. The published literature is replete with studies showing that Black patients are more willing to participate in clinical trials than other patient populations. As such, NBCI believes in advocating the potential benefits to patients in any clinical trial.

We have found that an educational program that highlights the following can be done cost-effectively and within the confines of a study's recruitment period:

• Overview of the disease in question and why it matters to Black people.
• Previous participation rates of Blacks in prior studies within the therapeutic area, the class of drug, or the specific program within the sponsor.
• The importance of Blacks participating in clinical trials, generally.
• The importance of Blacks participating in clinical trials within this class (either generically or for a specific study).
• Patients being safeguarded during clinical trials.
• The ongoing process of informed consent.
• The proper review and approval by a duly constituted and certified Institutional Review Board.
• The accessibility of resources for answering all participants' questions in a culturally and linguistically appropriate manner.

Principal 2

NBCI accesses culturally and linguistically appropriate literature, video, and web-based education modules which are critical to reaching Black audiences concerning the use of clinical trials. NBCI has regular success with the following approaches:

• Health Note.
• Health Sermon; and
• Health-At-A-Glance.

Principle 3

NBCI advocates for patient participation in clinical trials with investigators who have been trained in sound clinical practice in regulations, ethics, and cultural competence.

Principle 4

NBCI requires adequate resources to launch and sustain a church/community-based awareness program regarding all aspects of the trial.

Principle 5

NBCI maintains the need for adequate resources for the completion of the clinical trial and for reporting the knowledge of benefits and risks for diverse populations participating in the trial.

After evaluating CTEAPP for five years, NBCI recognized the need to raise the bar again. Such review led us to develop NBCI's National Clinical Strategic Task Force (NCS) with the following foci:

• Serve as an independent group of health professional national experts in diverse disciplines;
• Provide guidance, clinical oversight, recommendations, and scientific and technical support to NBCI;
• Develop and approve the training and education for all healthcare providers, volunteers, Church Leadership, and Health Corp Members that have a role in any NBCI special programs/grants/contracts; and
• Advocate for the COVID-19 vaccine and the importance of getting vaccinated.

Therapeutic Areas of Interest for African-American and Latino Communities: 11 Pillars of NBCI Clinical Research Approach

1. Cardiovascular Diseases
2. Cancer: (Liver, Kidney,Lung, etc)
3. Diabetes
4. Blood Diseases
5. Genetic Disease ( i.e. Sickle Cell)
6. Mental health
7. Acess to Care, lifestyles, and/or Selfcare
8. Collection of Health Data
9. Alzheimer's Disease
10. Rare Diseases
11. Others