list of resources and tools that can help clinical researchers and pharmaceutical companies increase diversity in their clinical trials
- FDA Guidance on Diversity in Clinical Trials: This resource provides guidance on the inclusion of underrepresented populations in clinical trials, including racial and ethnic minorities, women, and older adults.
- National Institute on Minority Health and Health Disparities (NIMHD): The NIMHD is dedicated to promoting health equity and addressing health disparities. They offer a variety of resources and programs aimed at increasing diversity in clinical research.
- ClinicalTrials.gov: This website is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. It includes information on the diversity of participants in clinical trials.
- National Institutes of Health (NIH) Inclusion Across the Lifespan Policy: This policy encourages the inclusion of individuals of all ages in clinical research studies.
- Diverse Elders Coalition: This coalition is committed to promoting policy and programs that improve aging for diverse older adults, including those from Arab ethnicities.
- Health Disparities Calculator: This tool, developed by the National Cancer Institute, estimates the potential impact of reducing disparities in cancer screening and treatment.
- Cultural Competence Program for Clinical Research Professionals: This program, developed by the University of Michigan, provides training for clinical research professionals on how to work with diverse populations and increase diversity in clinical trials.
- The Arab American Association of New York: This organization offers resources and support for Arab Americans in New York, including healthcare resources and advocacy.
- Arab American Medical Association: This association aims to promote health and wellbeing among Arab Americans and increase their representation in healthcare professions.
- Language Access and Proficiency Assessment (LAPA): This tool, developed by the National Institutes of Health, assesses language proficiency of participants in clinical trials and provides recommendations for language access services.
Examples of companies or organizations that have prioritized diversity in their research and development processes
- Eli Lilly and Company: Eli Lilly and Company is a global pharmaceutical company committed to increasing diversity in their clinical trials. They have established a Diversity in Clinical Trials working group, which is focused on identifying and addressing barriers to diverse participation in clinical trials.
- Merck: Merck has a long-standing commitment to diversity and inclusion in their research and development processes. They have established a Diversity and Inclusion in Clinical Trials (DICT) program, which is focused on increasing diversity in clinical trials through outreach, education, and engagement.
- Novartis: Novartis is a global pharmaceutical company that has made a commitment to diversity and inclusion in their research and development processes. They have established a Diversity and Inclusion (D&I) Council, which is focused on promoting diversity and inclusion across the company, including in clinical trials.
- Pfizer: Pfizer is a global pharmaceutical company that has a Diversity and Inclusion in Clinical Trials program, which is focused on increasing diversity in their clinical trials through outreach, education, and engagement. They have also established partnerships with patient advocacy organizations to help increase diversity in clinical trials.
- National Institutes of Health (NIH): The NIH is a federal agency that funds and conducts biomedical research. They have established policies and programs to increase diversity in clinical trials, including the inclusion of women and minorities in clinical research.
- Clinical Trials Transformation Initiative (CTTI): The CTTI is a public-private partnership focused on improving the efficiency and quality of clinical trials. They have established a Diversity and Inclusion Project Team, which is focused on identifying and addressing barriers to diverse participation in clinical trials.
However, participation among Arabic subjects in the U.S. and abroad remains under-represented. We aim to promote awareness and increase participation of subjects of Arabic ethnicity/descent.
Access to educational materials that can help researchers better understand the cultural and linguistic needs of Arab ethnicities in clinical research
- “Cultural Competence in Clinical Research” by NIH: This online training course is designed to help researchers understand the cultural and linguistic factors that may impact the participation of diverse populations in clinical research, including Arab ethnicities.
- “Health Literacy Universal Precautions Toolkit” by AHRQ: This toolkit provides resources and strategies for improving communication with patients with limited health literacy, including those from diverse linguistic and cultural backgrounds.
- “Understanding Arab Cultures” by Arab American National Museum: This online resource provides an overview of Arab culture, including values, beliefs, customs, and traditions that may influence health behaviors and attitudes towards clinical research.
- “Working with Interpreters in Clinical Research” by NIH: This resource provides guidance on working with interpreters in clinical research settings to ensure effective communication with non-English speaking participants, including those from Arab ethnicities.
- “Ethical Considerations in Research with Arab Americans” by Institute for Social Policy and Understanding: This publication provides guidance on ethical considerations in research with Arab Americans, including issues related to informed consent, privacy, and confidentiality.
- “Cultural and Linguistic Competence” by CDC: This resource provides guidance on cultural and linguistic competence in healthcare and public health settings, including strategies for improving communication and reducing health disparities.
- “Health Disparities Toolkit” by NIH: This toolkit provides resources and strategies for addressing health disparities among diverse populations, including Arab ethnicities, through research and community engagement.
- “Arab-American Demographics and Health Disparities” by Arab American Institute Foundation: This report provides an overview of Arab American demographics and health disparities, including challenges related to access to healthcare and participation in clinical research.
- “Engaging Arab Americans in Research: Best Practices and Lessons Learned” by University of Michigan: This resource provides guidance on engaging Arab Americans in research, including strategies for building trust and overcoming cultural and linguistic barriers.
- “Cultural Competence in Health Education and Health Promotion” by SOPHE: This resource provides guidance on cultural competence in health education and health promotion, including strategies for developing culturally and linguistically appropriate materials and interventions for diverse populations, including Arab ethnicities.
What are the Regulations Imposed on Pharmaceutical Industry to Engage in Decentralized Clinical Trials (DCTs) and Promoting Diversity?
Regulations imposed on pharmaceutical industry to engage in Decentralized Clinical Trials (DCTs) and diversity include:
- FDA guidance on DCTs, which emphasizes the importance of ensuring data quality, protecting participant privacy, and complying with regulatory requirements.
- The International Council for Harmonization (ICH) E6(R2) guidelines, which provide a framework for the management of clinical trials, including the use of technology and the importance of risk-based monitoring.
- The European Medicines Agency’s reflection paper on the use of virtual clinical trials, which provides guidance on the use of electronic health records and remote monitoring technologies in clinical studies.
- FDA guidance on enhancing diversity in clinical trials, which emphasizes the importance of including diverse populations in clinical trials to ensure that the results are representative of the broader population.
- The 21st Century Cures Act, which requires the FDA to develop and implement a plan to increase diversity in clinical trials, including the establishment of a public database of demographic information on clinical trial participants.
- The National Institutes of Health (NIH) policy on the inclusion of women and minorities in clinical research, which requires that clinical trials include women and minority participants in sufficient numbers to ensure that the results are generalizable to these populations.
- The European Medicines Agency’s reflection paper on the use of real-world data and real-world evidence in the context of regulatory decision-making, which highlights the importance of ensuring that real-world data and evidence are representative of the population.
What Are the Recent FDA Guidance’s on Diversity in Clinical Trials?
The FDA has recently issued several guidance’s related to diversity in clinical trials, including:
- Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs: This guidance was issued in 2020 and provides recommendations on ways to enhance diversity in clinical trial populations, including expanding eligibility criteria, using innovative trial designs, and adopting strategies to increase recruitment and retention of underrepresented populations.
- Assessing Adhesion with Pediatric Asthma Clinical Trials: This guidance, issued in 2020, provides recommendations on how to assess adherence to clinical trial protocols among pediatric asthma patients, with a focus on strategies for ensuring that diverse populations are included in clinical trials.
- Diversity and Inclusion in Clinical Trials – Guidance for Industry: This guidance was issued in 2019 and provides recommendations on ways to increase diversity and inclusion in clinical trials, including strategies for enhancing diversity in trial design, recruitment, and retention.
- Multiple Endpoints in Clinical Trials: This guidance, issued in 2017, encourages the use of multiple endpoints in clinical trials to increase the likelihood of detecting meaningful treatment effects across diverse patient populations.
Overall, this guidance emphasizes the importance of enhancing diversity and inclusion in clinical trials and provide specific recommendations for achieving these goals. They also highlight the importance of addressing barriers to diversity in clinical trial design and implementation, and the need for ongoing efforts to improve diversity and inclusion in clinical research.