Addressing the representation of minority populations in clinical research and trial outcomes.

The underrepresentation of minority populations in clinical research has long been a critical issue, impacting the generalizability of trial outcomes and the equity of healthcare advancements. Ensuring that clinical trials include diverse populations is essential for generating findings that are relevant to all racial and ethnic groups. Minority populations often face unique health challenges and may respond differently to treatments due to genetic, environmental, and socio-cultural factors.

1. Welcome Addressing the representation of minority populations in clinical research and trail outcomes D.V.SIVANI M .Pharmacy 111/072024 www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 1

2. Index Introduction Barriers to minority participation in clinical trails Consequences Representation of minority participation in clinical trails Conclusion www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 2

3. INTRODUCTION CLINICAL RESEARCH & CLINICAL TRAILS CLINICAL RESEARCH is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. CLINICAL TRAILS are important for discovering new treatments for diseases as well as new ways to detect, diagnose and reduce the chance of developing the disease MINORITY POPULATIONS Minorities refers the groups of people who are part of a smaller or less dominant segment of the population, often facing discrimination or underrepresentation. These groups can be defined by various factors, including: Race and ethnicity Gender and sexual orientation Religion and Socioeconomic status Age, Geographic location, Language and Cultural background www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 3

4. Barriers to minority participation in clinical trails 1. Mistrust: Lack of understanding the value, fear, stigma of participating, and communication style of investigator/staff. 2. Lack of comfort with the clinical trail process 3. Lack of information about clinical trails 4. Time & Resource constraints 5. Lack of awareness 6. Limited access to healthcare and research oppurtunities 7. Lack of diversity among researchers This Ethnic diversity gap can lead to less than ideal development of new medicines and can further exacerbate minority health issues. www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 4

5. www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 5 Consequences of the minority and gender gap in clinical trails This clinical trail diversity problem can have a serious consequences, as effectiveness of a particular medication or medical device can vary depending on ethnicity and gender Ex: 5-Flurouracil , a commonly used cancer chemotherapeutic drug, has been frequently reported to exhibit differences in drug response among different populations. A major side effect associated with this fluoropyrimidine based drug is the occurrence of hematologic toxicities, including leukopenia and anemia. These toxicities are often found to occur in higher rates in underrepresented populations than white/European Americans, this leads to miss opportunity to assess the adverse side effects in racial/ethnic minorities Ex: Syphilis tragedy : Nearly 400 patients with syphilis were deprived of appropriate therapy and were simply “observed” over a period of nearly 40 years to “better understand the natural history of disease.

6. Representation of minorities in clinical trails The NIH (National Institute of Health) Revitalization act of 1993, passed by congress inclusion of women& minorities in clinical trails. Congress should: 1. Pass legislation requiring inclusion of minorities in clinical trails for FDA approval of drugs. 2. Establish and /or empower an office off minority health within FDA. FDA Should: 1. Adopt NIH guidelines on the inclusion of women and minority populations . 2. Require rather than recommend adherence to its guidelines. NIH and academic institutions should: 1. Establish and maintain an infrastructure of minority physician and patient volunteers. 2. Establish training and/or mentorship programs for community based physicians NIH’s efforts aim to ensure high-quality, ethical, and inclusive clinical trails that advance medical knowledge and improve human health. www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 6

7. Some organizations working to improve diversity in clinical research include : National Minority Health Association (NMHA) Clinical Trail Transformation Initiative (CTTI) National Institute on Minority Health and Health Disparities (NIMHD) Startegies for Inclusion of Minorities in clinical trails: 1. Inclusive eligibility criteria 2. Cultural competency training: Educate researchers and staff on cultural differences. 3. Language access 4. Diverse research staff : Include minority researches, investigators, and coordinators. 5. Patient transportation, childcare 6. Offer Fair compensation for time and expenses. www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 7

8. www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 8 Trail outcomes for the participation of minorities in clinical trails: 1.Improved health outcomes: Minority participation in clinical trails can lead to improved health outcomes for diverse populations. 2.Enhanced Research Validity: Inclusive trails can enhance research validity by accounting for diverse lived experiences and exposures 3. Addressing health disparities: Minority participation can help address health disparities by identifying effective interventions for diverse populations 4. Trust Building : Inclusive clinical trails can help build trust between minority communities and medical researchers. 5. Increased access to innovative treatments: Participation in clinical trails can provide access to innovative treatments and interventions

9. CONCLUSION Inclusion of minorities in clinical trails is crucial for enhancing diversity and equity in research, improving health outcomes, and addressing health disparities. www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 9

10. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] www.clinosol.com | follow us on social media @clinosolresearch 10/18/2022 10