Diversity_DEI_Special Edition Issue Spring Summer 2024

DEI Special Edition Spring / Summer 2024

This is our first Special Edition of Interim Visits . In this issue we decid- ed to try something new. This issue is solely dedicated to Diversity, Equity and Inclusion (DEI). When the average American hears the word diversity their thoughts seldom go beyond that of race, and even that is limited to Caucasians, African - Americans and Hispanics. Though diversity includes race and ethnicity it also extends beyond it. In this issue we delve into diversity and inclusion regarding race and beyond. It is our hope that you find this issue enlightening for without diversity and inclusion there can be no equity. To achieve diversity we first need to understand and acknowledge where we fall short. Often we fail to realize how we as individuals may be impeding diversity. Hope- fully this issue will inspire deeper thoughts, conversations and actions. Please share your thoughts with us. Interim Visits needs your feed- back. We welcome your input! Please send us your recommenda- tions regarding topics of interest. Let us know if you would like to submit an article! Send your comments and suggestions to the follow- ing email address - info@interimvisits.com

Sincerely, Myra Fonville

DEI Special Edition Spring / Summer 2024

From the Editor

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Arab American Inclusion– A Call to Action for the Arab American Community – by Hadi Danawi, PhD Living in Silent Exclusion – Deaf and Hard of Hearing: Lack of inclusion in Healthcare and Research– by Ashley Walker Transgender Inclusion Matters– Bridging the Gap: Advancing Transgender Inclusion in Healthcare and Clinical Research by Liam Paschall Increasing Industry Diversity– Danielle Mitchell, A Warrior in the Fight for DEI in the Clinical Research Industry Accepting Autism – Why is Autism Always an Unspoken Exclusion Criterion in Clinical Trials -

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by Daniel Fox, PhD

Treatment Diversity - Why “ Seeing Color ” in Diabetes Healthcare is Vital Nurturing DEI for Natives - Dr. Adriann Begay: HEALer and DEI Champion Scientific Need for Diversity - Diverse (Proportional) Participation in Clinical Trials: a Scientific Necessity

by Shay Webb, MS Page 29

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by Arati “ Arti ” Bhosale, BDS, MPH Page 38

Carving Out a Space– The Launching of a Research Site: Scenic City Wellness Industry Expectations - The Past, Present, and Future: Beyond FDA Mandates

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by Barry Holmes, Jr. Page 52

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Promoting Diversity and Inclusion in Clinical Research: A Call to Action for the Arab American Community By Hadi Danawi, PhD In recent times, there have been significant developments in the realm of clinical research and diversity inclusion efforts. The FDA's diversity guid- ance, WHO's diversity guidelines, and the proposal to recognize individuals in the United States with Middle Eastern and North African ancestry as a distinct group in the 2030 U.S. census have brought to light the need for increased representation of the Arab American community in clinical trials. Addressing the challenges faced by this community in participating in clini- cal research and promoting diversity and inclusion is crucial. The "Arab Board for Clinical Research" is taking proactive steps to lead discussions on best practices and to establish an industry platform that responds effec- tively to this emerging demand. Challenges Faced by Arab American Community include limited awareness and access, language and cultural barriers, specific educational require- ments, and networking and connections. A significant portion of the Arab American community lacks knowledge about career opportunities in clinical research. Limited access to infor- mation about available positions, educational requirements, and necessary skills hinders their entry into the field. Language poses a significant chal- lenge for individuals who primarily speak Arabic or have limited proficiency in English. Clinical research often requires strong communication skills, and language barriers can hinder opportunities and qualifications. Positions in clinical research typically require specific educational backgrounds or de- grees, which may be inaccessible to many in the Arab American communi- ty. Building professional networks is crucial for career advancement. How- ever, Arab Americans may face challenges in establishing these networks, especially if they are new to the field or the country.

To maximize diversity and inclusion in clinical trial enrollment within the Arab American community, the "Arab Board for Clinical Research" is

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proposing the implementation of the following strategies including establishing community engagement, culturally and linguistically appropriate materials, lan- guage services, patient advocacy and support groups, training of culturally com- petent staff, collaborating with Arab American healthcare providers, designing inclusive studies, increasing representation in research teams, and providing transparent communications.

Actively engaging with the Arab American community through outreach pro- grams, community events, and partnerships with grassroots organizations to raise awareness about clinical trials and their benefits. Developing and distrib- uting educational materials tailored to the Arab American community in Arabic, addressing cultural norms, values, and concerns. Providing professional inter- preters or translators to facilitate effective communication between research staff and potential participants with limited English proficiency. Establishing pa- tient advocacy programs or support groups to provide guidance, information, and emotional support to Arab American individuals interested in participating in clinical trials. Training research staff to be culturally competent and sensitive to the needs and preferences of Arab American participants. Fostering partner- ships with Arab American healthcare providers, clinics, and hospitals to promote clinical trial opportunities, address participant concerns, and ensure culturally appropriate care. Considering the specific needs and preferences of the Arab American community when designing clinical trials, including factors like study location and visit scheduling to accommodate religious practices. Actively seek- ing representation from the Arab American community within research teams

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and leadership roles to address unique challenges and foster a more inclu- sive research environment. Collaborating with Arab American researchers and experts to drive research initiatives that are relevant and responsive to the community's needs. Ensuring clear communication of goals, benefits, risks, and outcomes of clinical trials to potential Arab American participants, allowing them to make informed decisions.

Hadi Danawi, Ph.D., chair and president, Arab Board for Clinical Research

Hadi Danawi, Ph.D., is a professor in global public health and epidemiology. He is ac- tively engaged in industrywide projects relating to remote consulting, higher educa- tion (master and doctoral programs in public health/healthcare administration), and clinical trial design and management. Danawi created the Arab Board for Clinical Re- search to promote diversity and inclusion of Arabs and Arab Americans in clinical re- search, the use of DCTs, and education and staffing of Arabs and Arab Americans in clinical research. He is also a co - founder of DiversiTrials. Danawi has expertise with pharmaco - epidemiology and drug safety/ pharmacovigilance with Big Pharma, including outcomes research and RWE. He is passionate about creating positive social change in underserved communities in Afri- ca and the Middle East and so established a not - for - profit organization with chapters in Lebanon and Ghana to provide technical assistance for project implementation, curriculum development, and training of local associates for self - reliance in disease prevention, health services, and family and community health initiatives.

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Deaf and Hard of Hearing: Lack of Inclusion

In Health Care and Research

by Ashley Walker, PharmD

Approximately forty - eight million Americans live with some form of hearing loss in one or both ears. Over the years, laws were put in place and various advances in technology have made it possible for individuals within this unique community to adapt to everyday living. One of the most powerful laws, the Americans with Disabilities Act of 1990, exists to ensure that people with disabilities have equal opportunities to participate in society. Violation of the Americans with Disabilities Act of 1990 can result in fines for non - compliance, bad publicity for place of business, and even punitive damages. Despite the availability of various resources such as American Sign Language interpreters, Video Remote Interpreting, speech to text software, etc. accessi- bility in the healthcare setting is sorely lacking. The reasoning behind such poor accessibility is due in part to the “ one size fits all ” mentality. All individuals with hearing loss are not the same. For ex- ample, someone who loses his/her hearing later in life may not know sign

language. There- fore, it would be inappropriate to- provide accessible communication in the form of sign language inter- preters. Some- one who com-

municates using American Sign Language may have difficulty understanding written English. Also, not all deaf or hard of hearing individuals have lip - reading capabilities. Deaf and hard of hearing individuals lose autonomy when it comes to making decisions pertaining to their health when the re- quested method of communication is denied or exchanged with alternatives and futile options.

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Now, picture this. Imagine wanting to participate in a clinical trial or even a simple healthcare survey. Yet, you are not able to do so because of communication barri- ers. It's bad enough to be left in the dark when it comes to making decisions per- taining to your own health. Imagine what it ’ s like to have decisions made for you without even knowing the impact of such decisions. In all honestly, when it comes to healthcare and research, it is a rarity to find any sort of article or clinical trial that specifically dissects or includes individuals with hearing loss. Yet, there are various articles available about healthcare literacy and individuals with hearing loss. Without including individuals from this unique community, several things happen. An entire community is completely overlooked when it comes to the development of medicine or design of medical devices. For example, suppose you want to create a new insulin pump. It beeps to alert the user of any discrepancies in glucose read- ings. How is the individual with hearing loss supposed to be alerted of such discrep- ancies? Questions like these are overlooked when failure to include the very popu- lation that brings attention to them. It is also not an accurate representation of soci- ety. Society is not composed of cookie cutter versions of the same person. How can efficient and effective advances be made with medicine and medical equipment without having a negative impact on anyone with a disability? With the existence of the Americans with Disabilities Act of 1990 and astronomical advances in technology, there really are no excuses as to why members of the deaf and hard of hearing community are continuously excluded from clinical research and trials. It is time to stop hiding behind the multitude of excuses such as “ who is going to pay for the accommodation? ” or “ I don ’ t know where to start. ” Instead, be inclusive by providing the client or patient ’ s requested accommodations. Afterall, including individuals from this unique community can help improve medication ad- herence and health outcomes.

Ashley Walker, PharmD

Dr. Ashley R Walker is a pharmacist, entrepreneur, and an advocate. Dr. Walker holds a Doctor of Pharmacy degree from Xavier University of Louisiana and a Bache- lors of Science in Biotechnology from Rochester Institute of Technology. She has been a pharmacist for 6 years and recently transitioned into full time entrepreneurship. Prior to her transition, she has had experience in retail pharmacy, hospital pharmacy, and long term care pharmacy. With her personal experiences as a deaf pharmacist and advocate for the deaf and hard - of - hearing community she aims to remind the world that deafness should not be viewed as a DIS - ability but rather a UNIQUE - ability.

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by Liam Paschall

Ensuring transgender inclusion in clinical trials and the broader medical field is crucial for achieving health equity and providing comprehensive, respectful care to all individuals. In this article, I discuss some of the reasons, methods, and significance of fostering such inclusion, partially informed by my experi- ences as a transgender man, to pave the way toward a more inclusive clinical and healthcare landscape. Before you continue reading this article, it may be helpful for you to under- stand the terminology. While many sites provide definitions, the Human Rights Campaign (HRC) has an extensive glossary of frequently updated terms.

Why Transgender Inclusion Matters

The healthcare system often places transgender individuals at the margins, leading to experiences of exclusion and marginalization. I have my own list of stressful, anxiety - ridden, often frightening personal encounters. Below are just a few. • I was misgendered on the operating table during a routine proce- dure, despite prior discussions with the surgeon and her staff and assurances that my gender identity was acknowledged in MyChart. I didn ’ t know whether to get up and leave, say some - thing and risk being ridiculed … or worse while I was under seda - tion, or ignore it and have the procedure. • My journey with gender - affirming hormone therapy (GAHT) has introduced new health challenges, underscoring the critical re- search gap in transgender health needs.

DEI Special Edition Spring / Summer 2024

• I have decided to undergo a hysterectomy. To get this process started, my primary care doctor sent me to a Women's Health fa- cility (which terrifies me). How am I supposed to feel, checking in for a hysterectomy, probably the only man in the entire waiting room? In addition, I don ’ t know if the doctor I've been assigned to has experience with transgender patients. This introduces an extra dimension of anxiety and fear into an already daunting healthcare journey.

Barriers to Clinical Trials and Medical Care

• Lack of FDA Guidance: Although the FDA has issued various guid- ance documents to enhance diversity and inclusion, the transgender community has not been adequately addressed. • Excellent article in Worldwide Clinical Trials: Mapping the Way for Transgender Inclusion in Clinical Trials • Lack of Representation: The underrepresentation of transgender individuals in clinical trials creates significant knowledge gaps. • Discrimination and Stigma: Discriminatory attitudes from healthcare providers can deter transgender people from seeking care. • Inadequate Training: A lack of training among healthcare profes- sionals contributes to subpar care. • Misgendering and Disrespect: Experiences of disrespect can dis- courage transgender individuals from future healthcare engage- ments. • Inaccessibility of Gender - Affirming Care: Limited access to gender - affirming treatments affects overall health and well - being. Insurance Barriers: Financial obstacles often prevent access to nec- essary medical treatments. • Many transgender individuals are unemployed or under- employed. Without stable or sufficient income, transgender individuals may struggle to afford out - of -

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pocket expenses for healthcare, including doctor's visits, medica - tions, surgeries, and any associated travel costs. This financial barrier can lead to delayed or foregone care, negatively im pacting their health. Unemployment/underemployment signifi - cantly hampers the ability of transgender individuals to access medical care, resulting in a wide range of adverse health out - comes. • Privacy Concerns: The fear of being "outed" deters participation in clinical trials. • Cultural and Language Barriers: These factors can alienate transgender individuals from different cultural backgrounds. • Physical Environment: The absence of gender - neutral facilities can make healthcare settings unwelcoming. • Bias in Clinical Research Design: Many trials exclude transgender, nonbinary, and gender nonconforming individuals by design.

Anti - transgender legislation and hateful rhetoric significantly contribute to barri- ers in medical care and clinical research for transgender individuals in several profound ways: 1. Increased Stigma and Discrimination: Such legislation and rhetoric reinforce societal stigma and discrimination against transgender people. This stigma can permeate healthcare settings, making transgender individuals feel unwelcome, misunderstood, and un- safe. Healthcare professionals influenced by these biases may pro- vide suboptimal care or refuse care altogether. 2. Mental Health Impact: The negative psychological impact of hostile legislation and rhetoric cannot be overstated. It exacerbates stress, anxiety, and depression among transgender individuals, which can deter them from seeking medical care due to fear of discrimination or mistreatment. This heightened mental distress can also affect participation in clinical research, as individuals may be less willing to engage with systems they perceive as hostile or unsafe. 3. Legal and Policy Barriers: Anti - transgender laws can directly restrict access to gender - affirming treatments and care, making it difficult or

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impossible for transgender people to receive medically necessary ser - vices. These barriers can extend to clinical research, where the exclu - sion of transgender individuals from studies can be justified under the guise of these laws, further marginalizing the community and hinder - ing the development of tailored healthcare interventions. 4. Educational Gaps: The propagation of hateful rhetoric and the enact ment of discriminatory laws can lead to significant gaps in medical education and training regarding transgender health. This lack of education results in healthcare professionals who are unprepared to competently address the unique healthcare needs of transgender patients, thus contributing to inadequate care and a reluctance among transgender individuals to participate in clinical research. 5. Economic Impact: Discriminatory policies and rhetoric can exacerbate economic inequalities for transgender individuals by limiting their em - ployment opportunities and access to health insurance. Many cannot afford the healthcare they need without adequate insurance coverage, including participation in clinical trials that may require insurance cov - erage or out - of - pocket expenses. 6. Restricted Access to Gender - Affirming Care: Legislation that targets or limits access to gender - affirming care (such as hormone therapy or surgical interventions) not only affects the physical health of transgender individuals but also limits the scope of clinical research in these areas. By restricting access to these essential services, such laws hinder the ability of healthcare professionals to provide comprehen - sive care and conduct research on the effectiveness and outcomes of gender - affirming treatments. 7. Social Isolation and Marginalization: Hateful rhetoric and anti - transgender policies contribute to the social isolation and marginaliza tion of transgender individuals, making them less likely to seek medi cal care or participate in research. This isolation can be exacerbated in environments where transgender people do not feel they have the social support or community backing to safely navigate healthcare systems. Anti - transgender legislation and rhetoric create a hostile environment that not only impedes the ability of transgender individuals to access quality healthcare and participate in clinical research but also contributes to broader societal harm by reinforcing discrimination, perpetuating health disparities, and undermining public health efforts aimed at achieving equity and inclusion.

How can we make clinical trials and the broader medical field more inclu- sive and welcoming of the transgender community?

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Some Essential Steps for Clinical and Medical Staff •

Introduce Yourself with Pronouns: Starting interactions by sharing pronouns can significantly ease anxiety for transgender patients. • Use Chosen Names and Pronouns: It's vital to respect patients' cho- sen names and pronouns in all forms of communication. • Educate Yourself and Your Staff: Ongoing education on transgender health issues and cultural competency is essential. • Modify Intake Forms: Forms should allow patients to indicate their gender identity and pronouns beyond the binary options. See the attached example I created some time ago. • Implement a Non - Discrimination Policy: Policies should explicitly protect against discrimination and unfair treatment based on gender identity and expression. • Create Inclusive Spaces: Providing gender - neutral bathrooms is one step toward making practices welcoming for everyone. • Involve Transgender Individuals in Decision - Making: This ensures that policies and services reflect the needs of transgender patients. • Promote Visibility: Displaying inclusive materials signals a safe space for the transgender community. • Offer Gender - Affirming Care Training: Staff should receive founda- tional and ongoing specialized training on how to create an inclusive, welcoming environment for transgender patients. • Collaborate with Transgender Health Organizations: This helps stay aligned with the best practices and latest in transgender healthcare.

The Importance of Respectful Care

Providing respectful care involves more than using the correct names and pro- nouns; it requires a commitment to understanding and addressing the unique healthcare needs of transgender individuals. Engaging with local transgender organizations and involving transgender people in focus groups and policymak- ing ensures that healthcare services and research are both relevant and im- pactful.

Conclusion

Achieving transgender inclusion in clinical trials and healthcare is an ongoing process that demands a dedication to understanding the specific needs of transgender individuals, dismantling the barriers they face in accessing care, and ensuring that medical research is inclusive of all gender identities. By adopting inclusive practices, actively engaging with the transgender community, and em- phasizing respectful care, the medical field can advance toward true health equi- ty for everyone.

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Helpful Resources: •

The World Professional Association for Transgender Health (WPATH) promotes the highest standards of health care for individuals through the articulation of Standards of Care (SOC) for the Health of Transsex- ual, Transgender, and Gender Nonconforming People. The SOC are grounded in the most current scientific evidence and expert consen- sus. • National Institutes of Health (NIH) – Simply search for: "transgender" or "nonbinary" in the Search field. • Fenway Health - The Trans Health Program at Fenway Health sup- ports members of trans and gender - diverse communities, their fami- lies, and the providers who serve them. • Medical professionals trained and specializing in transgender care. • International Lesbian, Gay, Bisexual, Trans and Intersex Association • Medical publications, articles, and studies from legitimate sources, books, and …. getting to know a transgender person, allowing them to share their stories, their experience, and their journey. A Call to Action I call on healthcare professionals, policymakers, clinical research organizations, sponsors, and all healthcare and clinical research stakeholders to dedicate them- selves to continuous education, policy reform, and the active inclusion of transgender voices in every facet of healthcare and planning, delivery, and clinical research endeavors. Link to Downloadable Trans Healthcare Intake Form Guidance - https://img1.wsimg.com/blobby/go/85e572da - 3a88 - 41bd - acbc - 533916dea393/ downloads/Trans%20Inclusive%20healthcare.pdf?ver=1715573690528

Liam Paschall

Connect with Liam on LinkedIn

Liam is a dedicated advocate and voice for the transgender community. With a passion deeply rooted in fostering understanding and inclusion, he is devoted to educating others on the nuances of trans experiences . Through public speaking engagements, comprehensive work- shops, and tailored training sessions, Liam works tirelessly to bridge gaps in knowledge and empathy. His efforts extend across various platforms and venues, including organizations, medical facilities, schools, churches, and public events. Beyond educating, Liam is committed to actionable change, offering insights into how institu- tions and individuals can evolve toward genuine allyship. His work enlightens and empowers his audience to become proactive participants in the journey toward equity and acceptance

DEI Special Edition Spring / Summer 2024

Danielle Mitchell, A Warrior in the Fight for DEI in the Clinical Research Industry

by Myra Fonville

OVERVIEW: In the past, I ’ ve spoken to Danielle Mitchell several times; howev- er, it wasn ’ t until I had the opportunity to interview her that I felt I REALLY got to know her. As many of you know, Danielle is the Founder and CEO of Black Women in Clinical Research (BWICR). Founded in 2019, BWICR has grown from an idea to an organization with over 16,000 followers and a leader with over 22,000 followers. In this article you will learn about Danielle the Warrior!

What prompted you to start Black Women in Clinical Research (BWICR)? The pivotal moment came during an Investigator meeting, where I found myself in a room filled with hundreds of professionals, only to realize that there were just two Black Women present, including myself. This eye - opening encounter raised important questions and highlighted the urgent need for a network that specifically addresses the underrepresentation and challenges not only faced by Black Women in the industry but also those whom it benefits. Were you surprised by the response you received? Yes, I was indeed surprised by the response I received. The sheer volume of feedback and the depth of insight shared truly caught me off guard. It ex- ceeded my expectations and provided valuable perspectives that I hadn't considered before. It's always humbling and invigorating to see such engage- ment and contribution from others. What was your primary goal when you started the group? When I first started the group, my primary goal was to create a supportive community where like - minded individuals could come together to share knowledge, exchange ideas, and collaborate on projects related to our shared

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interests. I wanted to foster a space that promoted learning, growth, and mean- ingful connections among members. Additionally, I aimed to provide a platform for individuals to seek guidance, offer support, and celebrate achievements with- in our collective journey. Have your goals changed since the group ’ s inception? Yes, over time, our goals have evolved and adapted in response to the changing needs and dynamics of the group. While the core values of fostering community, knowledge - sharing, and collaboration remain intact, we have refined our focus and strategies to better serve our members. As we've grown and learned to- gether, new opportunities and challenges have emerged, prompting us to adjust our objectives to ensure continued relevance and effectiveness. Our commitment to supporting each other and advancing our shared interests remains steadfast, but the specific ways in which we pursue these goals may have shifted in re- sponse to our collective experiences and aspirations. What services does BWICR offer? Black Women in Clinical Research (BWICR) offers a variety of services aimed at supporting and empowering Black women professionals in the field of clinical re- search. Some of the key services we provide include: • Professional Development Workshops: BWICR organizes workshops and training sessions focused on enhancing skills relevant to clinical research, such as protocol development, data analysis, and regulatory compliance. • Networking Events: We facilitate networking opportunities for Black women in clinical research to connect with peers, mentors, and industry profession- als, fostering collaboration and career advancement. • Mentorship Programs: BWICR offers mentorship programs pairing experi- enced professionals with early - career researchers to provide guidance, sup- port, and career development advice. • Educational Resources: We provide access to resources, articles, and educational materials on topics relevant to clinical research, including best practices, industry trends, and professional development tips. • Advocacy and Representation: BWICR advocates for greater representation of Black women in leadership positions within the clinical research field and works to address systemic barriers to their advancement. • Community Support: We create a supportive community where Black women in clinical research can share experiences, seek advice, and find solidarity in over- coming challenges they may face in their careers.

Overall, BWICR is committed to fostering the success and advancement of Black women profes- sionals in clinical research through education, networking, mentorship, advocacy , and commu- nity building.

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How many women do you estimate have been helped over the years? We are incredibly proud of the tangible impact BWICR has had on our com- munity. Since our inception, we've not only assisted over 600 individuals in securing meaningful jobs within the clinical research industry but have also made a profound and far - reaching impact on thousands of people's lives. Our efforts extend beyond mere numbers; they encompass the empower- ment, inspiration, and transformation of individuals and communi- ties.Through our comprehensive programs, initiatives, and advocacy, we've created a ripple effect that reaches far beyond the individuals directly bene- fiting from job placements. By fostering a supportive and inclusive environ- ment, we've empowered countless individuals to pursue their passions, de- velop their skills, and achieve their career aspirations within the clinical re- search field. Do you feel that most companies are serious about DEI or is it simply a politi- cally correct point of discussion these days? The perception of companies' commitment to diversity, equity, and inclusion (DEI) can vary widely depending on individual experiences and observations. While some companies demonstrate genuine dedication to DEI initiatives, others may view it as a checkbox or a superficially politically correct discus- sion point. It's important to recognize that DEI efforts can range from genuine systemic changes to mere lip service, and discerning between the two requires a deeper examination of a company's actions rather than just its stated in- tentions. Factors such as the diversity of leadership, the implementation of inclusive policies and practices, the allocation of resources towards DEI ini- tiatives, and the transparency and accountability in reporting progress all contribute to understanding a company's sincerity regarding DEI. Ultimately, while DEI discussions have become more prevalent in recent years, genuine progress requires tangible actions and sustained commitment from companies to create inclusive environments where all employees can thrive, regardless of their background or identity. Have you been surprised by the outpouring of support by your sponsors? Yes, the outpouring of support from our sponsors has been truly remarkable and humbling. We are immensely grateful for their generosity and dedica- tion to our cause. Their support not only helps us achieve our goals but also reinforces the importance of our mission and the impact it has on the com- munity. It's inspiring to see how our sponsors rally behind us, providing re- sources, expertise, and encouragement every step of the way. Their unwa- vering commitment motivates us to strive for excellence and make a mean- ingful difference in the lives of those we serve.

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Have any of these sponsors/companies made commitments that have helped with DEI since BWICR was formed? Yes, several of our sponsors and partner companies have made com- mitments that have significantly contributed to advancing diversity, equity, and inclusion (DEI) initiatives since the formation of BWICR. Overall, the commitments made by our sponsors have played a cru- cial role in furthering BWICR's mission of empowering and advancing Black women in clinical research while promoting diversity, equity, and inclusion in the broader healthcare and life sciences fields. We deeply appreciate their partnership and continued support in this important work.

How long do you think it will take for companies to acknowledge the glass ceiling women in gen- eral face in this industry? The majority of employees working in clinical research are women yet most upper manage- ment positions are held by men. The acknowl- edgment of the glass ceiling that women face in

various industries, including healthcare and life sciences, varies among companies and is influenced by a multitude of factors such as organizational culture, leadership perspectives, and external pres- sures. While some companies have already recognized and taken steps to address gender disparities, others may still be in the process of acknowledging or understanding the extent of this issue. Predicting how long it will take for widespread acknowledgment to occur is challenging and depends on continued efforts from various stakeholders, including advocacy groups, industry leaders, policymak- ers, and individuals within organizations. Increasing awareness, pro- moting education about the barriers women face, and advocating for inclusive policies and practices are essential steps in accelerating this process. Ultimately, achieving true gender equity and breaking through the glass ceiling will require sustained commitment and collaborative efforts from all sectors of society. While progress may take time, ongo- ing dialogue, advocacy, and action can help pave the way towards a more equitable and inclusive future for women in the industry.

Do you feel that BWICR has been the catalyst for the formation of similar groups? Yes, I believe that that has inspired the formation of multiple groups in the Clinical Research industry.

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What do you attribute the success of BWICR to? The unmet need stemming from the authenticity of my own personal experi- ence and the glaring lack of opportunities within the industry served as the driving force behind the inception of BWICR. Recognizing the systemic barri- ers and biases that hindered my own progression and witnessing similar struggles faced by countless others, I was compelled to take action. The mis- sion of BWICR, rooted in the authentic experiences of marginalized individu- als like myself, struck a chord with many who were grappling with similar challenges. What do you foresee for the future of clinical research with regards to DEI? The future of clinical research with regards to diversity, equity, and inclusion (DEI) holds great promise but also requires concerted efforts to address ex- isting disparities and promote meaningful change. It will require ongoing commitment, collaboration, and advocacy from all stakeholders involved. By prioritizing diversity, equity, and inclusion, we can ensure that clinical re- search is more robust, ethical, and reflective of the diverse needs of all individ- uals. What is the main thing that you want companies to understand with regards to DEI/BWICR? The main message we want companies to understand regarding diversity, equity, and inclusion (DEI) and the mission of BWICR is that fostering a di- verse and inclusive workplace isn't just a moral imperative – it's also a stra- tegic advantage. By embracing DEI principles and actively supporting organ- izations like BWICR, companies can unlock innovation, enhance employee engagement, and drive business success. We want companies to recognize that DEI isn't just about meeting quotas or checking boxes; it's about creating environments where all employees feel valued, respected, and empowered to contribute their unique perspectives and talents. Companies that prioritize DEI are better equipped to attract and retain top talent, foster creativity and innovation, and build stronger relation- ships with customers and stakeholders. Additionally, we want companies to understand that supporting BWICR and similar organizations isn't just a one - time gesture – it's an ongoing commit- ment to creating lasting change. By partnering with BWICR, companies can demonstrate their dedication to promoting diversity and inclusion in the clini- cal research industry, driving positive impact both within their organizations and across the broader community.

Ultimately, we want companies to understand that DEI isn't just a trend or a

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buzzword – it's a fundamental aspect of building a more equitable and prosper- ous future for all. By working together with organizations like BWICR, companies can help create a world where everyone has the opportunity to thrive, regardless of their background or identity.

CONCLUSION: Danielle Mitchell is a woman with extraordinary foresight and she has used that foresight to become a catalyst for change within the clinical research industry. While everyone else focused solely on increasing patient di- versity Danielle saw the need for diversifying the clinical research workforce. She understands that in order for patients to agree to participate in clinical trials they must first trust the staff. Her understanding and forethought led Danielle to create an organization dedicated to educating, training and mentoring black women interested in entering and/or advancing in the clinical research industry. Black Women in Clinical Research increased awareness regarding the lack of diversity in the industry and it continues to pave the way for all.

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Why is Autism an Unspoken Exclusion Criterion in Clinical Trials ?

By Daniel J. Fox, MPH, PhD

A CRO recently learned of my commitment to serving our autistic community and asked me to help them recruit autistic patients for a new trial:

“ Of course! Anything for our community. What did you have in mind? ” “ We were hoping you would reach out to your autistic community and physi- cians to refer participants to our active clinical research sites. ” “ I ’ m sorry – that won ’ t work with the autistic community. We would need the visits to be performed in a familiar environment to accommodate their autistic needs. ” “ It ’ s far too late in the process to make changes like that! Are you sure you can ’ t just refer them to our sites? ” I declined the opportunity. There was no way an inconsiderate strategy like that would work for an autistic patient population. What ’ s more, the same organization who was managing the trial was not willing to consider the needs of the same patients they were trying to enroll. Unfortunately – this scenario is not isolated. Autistic patients are almost al- ways alienated from clinical trial participation not because they, as autistic individuals, are excluded from an IRB - approved protocol, but rather because we as an industry exclude them when we do not accommodate their needs. “ Please Don ’ t Take My Structure ” Perform a quick Google search: “ Autism Spectrum Disorder (ASD) requires structure, ” and let the results speak for themselves. Consistency and routine are not just a luxury for autistic patient populations – they are a necessary and well - documented lifestyle requirement. It can take years to develop this consistent relationship for an autistic individ- ual. At times, caretakers and occupational therapists admit it is a good day when an autistic patient successfully takes a single step into a physician ’ s hallway. The next day, another step … and another. Years later, that autistic patient may finally trust the environment enough to accept care in the exam room. We have witnessed dedicated physicians and dentists set up in a

DEI Special Edition Spring / Summer 2024

hallway because patients refused to enter a room. What ’ s more – the familiar voice, a communication by relationships, that special picture hanging at a slight tilt in the hallway, even specialized sign language for our nonverbal community is absolutely critical to delivering care. Now imagine a world … where after years of trust - building with a healthcare pro- vider, you approach an autistic patient and ask them to leave that same environ- ment for a clinical trial. The resounding answer will be, “ No – I can ’ t leave my doctor. ”

We would not ask a blind person to personally drive to a site and we wouldn ’ t ask a deaf individual to participate in a trial solely with an audio - only phone. Why would we ask autistic patients to participate in clinical trials solely by abandoning the structure

and routine they have developed to survive?

The answer – we won ’ t. It would completely derail years of lifestyle manage- ment and potentially cause meltdowns for the same patients we are working to help. Thus, autistic patients do not participate in clinical trials out of choice, but out of the necessity to survive away from a well - known and unfavorable out- come. Patients are NOT their Diagnoses The first thing that comes out of a colleague ’ s mouth when I tell them I ’ ve start- ed an autism - friendly clinical trial site: “ Oh I know a few Autism clinical trials that you might be interested in. ”

And the second thing that comes out of my mouth: “ Just because I run an autism - friendly clinical trial doesn ’ t mean I specialize in autism clinical trials. ”

There is far more complexity to autistic patients than their ASD diagnosis. They suffer from and are fully qualified for trials that focus on seizures, anxiety, de- pression, diabetes, metabolic disorders, and so many more. How may we include Autistic patients comfortably in clinical trials? To welcome autistic patients into our trial portfolios, we must look beyond ASD, see them as comprehensive patients and individuals, and understand how we as clinical research professionals can accommodate their needs.

DEI Special Edition Spring / Summer 2024

Bring the trial, as much as possible, into familiar environments of their homes and familiar physician offices.

Utilize DCT utilities as a vector to connect the needs of our patients to the regu- lations of our industry.

Do not force local physicians into becoming the PIs or Sub - Is and consequently discourage them from engaging, alongside the patients who trust them, in clini- cal trials. Instead, treat them solely as the local HCPs who have fostered an in- valuable relationship with our patients.

Ahmed Fall from Raleigh, NC area– Autistic 9 year old

“ The Regulators and Sponsors won ’ t allow this. ” – FALSE! Get ready. The FDA ’ s upcoming DCT guidance is laying the groundwork to allow local HCP offices the ability to “ host ” clinical trial visits. Clinical research is com- ing to local HCP offices. Once published, HCP offices may collaborate with community sites via Task Logs without extensive staff - level training requirements and Sponsors will indirectly give permission to perform “ DCT Compatible Trial Visits ” as they begin to in- clude a DCT component into IRB - approved protocols. We are witnessing in this industry the groundwork to access patient populations throughout healthcare settings. The only reason we do not accommodate our autistic patients in re- search …. will be our own. How may CRAs help to accommodate autistic trial partici- pants? I ’ ve talked to many a CRA about DCT utilities and the DCT guidance. Their knee - jerk reaction is – there ’ s no way this will ever work and this would be a disaster to monitor. I get it! Its new, its unknown, nobody wants to be the failing guinea pig, and it ’ s so new that we do not yet have rulebook or guard rails to follow.

DEI Special Edition Spring / Summer 2024

That does not mean, however, that its not something worth developing to en- hance our community service.

As CRAs, you have a unique opportunity not to discourage innovation to enhance Autism DEI, but rather to unite our research community under a standard of ac- ceptance. You have eyes and ears in so many different site environments, and therefore the power to help sites struggle through creating their new systems DCT and DEI logistics. Know the regulations, be the guides your sites need, and the advocates for our community patients. And so – as you complete your monitoring visit and review your standard source at your standard site – please know there are thousands of patients out there you are not seeing. They are willing to follow the study protocol to the “ t ”, literally, they suffer from indications that our trials could help with, they will likely be one of the end - patients who rely on these new therapies are approved, and they are denied the opportunity to participate in your clinical trial not because of choice or protocol exclusion, but because we as clinical research professionals are unwilling to adapt our processes, even with the defensible regulatory guidance right in front of our eyes, to accommodate their needs. Please – do not deny willing and qualified autistic patients the ability to be autistic participants. Imagine what this population ’ s enrollments could do for our entire industry – if we only worked together to create an industry structure that wel- comes them into our trials.

Daniel Fox, MPH, PhD

Daniel Fox, MPH, PhD is the Founder of Clinical Research Payment Network and Land of Lincoln Clinical Research. He has also co - founded and led as an executive the Save Our Sites alliance and two non - profits dedicated to supporting our autistic communities. As if that were not enough Dr. Fox is Co - Founder of DiversiTrials" and he is an official di- versity Reviewer for the Global Public Health Credentialing Board. After losing his child to a rare disease, Dr. Fox dedicates his life to ensuring everyone, EVERYONE, can access clinical trials regardless of their age, race, disability, gender, gender identity, socioeco- nomic status, or geographic location. If you feel as strongly as he does about clinical research rights in across our communities, please reach out and join his mission.

DEI Special Edition Spring / Summer 2024

Why “Seeing Color” in Diabetes Healthcare is Vital

by Shay Webb, MS

Diabetes can feel like a paint palette while you are the canvas, but it ’ s important to recognize the colors and hues of your patients as a diabetes healthcare provid- er.

With the lack of healthcare provid- ers of color — specifically Black providers — it often feels like the only choice is a provider who does not share my background. While learning about different cul- tures is always valuable, having a healthcare provider who under- stands my culture firsthand is priceless for a person with diabe- tes.

“ Type white ” diabetes ”

Without that shared understand- ing and experience, many patients often go heard without being listened to while being stigmatized. As a person of color living with type 1 diabetes (T1D), this dis- ease has commonly been referred to as “ type white ” diabetes, because there were significantly fewer people of color living with the disease.

Or so we thought.

Upon entering college, I was introduced and relieved to see that there were more T1Ds of color than I had ever realized. I no longer felt so alone, no longer the black girl with a “ white ” disease.

The problem is that people of color are not well represented in the face of diabe- tes care. Whether in doctor ’ s offices, advocacy, or social settings, the face of T1D

DEI Special Edition Spring / Summer 2024

had always remained the same.

Many providers probably don ’ t realize how detrimental this lack of repre- sentation could impact patients.

When “ seeing color ” isn ’ t racist or discriminatory

Here ’ s an example when it is very important to see color and more im- portantly pattern. To see color does not mean to be racist or discriminatory, but rather to be cognizant. Seeing color is a way of addressing the issue that: • People of color endure racial bias significantly more often than their White counterparts. • People of color endure colorism and health inequity within and outside of their communities. It is also important to understand that patients from African - American and Latino communities have lower rates of using modern diabetes technology and experience more diabetes complications than their counterparts from other racial groups. While this association may appear disheartening, this is not the end.

Providers can improve outcomes and relationships with patients by starting with the following:

1. Check engine soon! Just as a mechanic has the ‘ prescription ’ to repair a car by listening to understand what may be going wrong, providers must listen intentionally to their patients to not only understand the needs of the patient, but to recognize that each patient within the same background may not respond the same way. 2. Piece the puzzle. Healthcare is like a puzzle. There ’ s a lot of little pieces that need to be put together to form the bigger picture. Therefore, to

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