Engaging Community-Based Practices in Clinical Trials

Sally L. Hodder

Dr. Hodder is an infectious diseases physician whose nearly 40-year career has included leadership positions in the pharmaceutical industry and clinical and translational research programs. Currently, she is the Associate Vice President for Clinical and Translational Research, Director of the West Virginia Clinical and Translational Science Institute, Professor of Medicine, and holds the Preeminent Scholar Chair at West Virginia University. Previous positions include Director of HIV Programs at Rutgers New Jersey Medical School in Newark, New Jersey (2006 – 2014) and Vice President, Bristol-Myers-Squibb Virology Medical Affairs (2000-2005). Dr. Hodder received her bachelor’s degree in chemistry from Mount Holyoke College and her M.D. from Case Western Reserve University School of Medicine. Her primary area of research is in the areas of HIV treatment and prevention and improving health outcomes in rural America. In 2025, Dr. Hodder was inducted into the National Academy of Medicine.

Gregory E. Simon

Gregory Simon MD MPH is an investigator at Kaiser Permanente Washington Health Research Institute, a psychiatrist in Kaiser Permanente’s Behavioral Health Service, and a faculty member of the Kaiser Permanente School of Medicine and the University of Washington. Dr. Simon’s research focuses on improving access to and quality of mental health care, especially for mood disorders and people at risk for self-harm and suicide. Specific areas of research include improving adherence to medication, personalization of treatment for mood disorders, pragmatic clinical trials, prediction of suicidal behavior, population-based suicide prevention programs, and racial/ethnic disparities in mental health care. Dr. Simon leads the Mental Health Research Network, a consortium of mental health research centers embedded in large health systems across the US.

Richardae Araojo

Richardae “Chardae” Araojo, Pharm.D., M.S., is the President and Founder of Araojo Advisory Group, LLC, where she provides regulatory consulting and strategic advisory services. Dr. Araojo previously served more than 20 years at the U.S. Food and Drug Administration (FDA) and with the U.S. Public Health Service (USPHS). During that time, she held a variety of positions at the FDA including Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity in the Office of the Commissioner, and Director of the Office of Medical Policy Initiatives in the Center for Drug Evaluation and Research. While at the FDA, she led a variety of broad-based medical and clinical policy initiatives to improve the science and efficiency of clinical trials and provided leadership and direction on health disparity and health equity matters for the Agency. She also fostered collaborations and partnerships with federal agencies, academic institutions, industry, and patient and community organizations. Dr. Araojo retired from the USPHS in 2024 as a Rear Admiral (RDML) and Assistant Surgeon General. She received her Doctor of Pharmacy Degree from Virginia Commonwealth University and Master’s Degree in Pharmacy Regulation and Policy from the University of Florida.

Laura Ferrera

Laura is a Clinical Research Manager with the Oregon Rural Practice-based Research Network, specializing in the design and management of clinical trials. She is dedicated to advancing healthcare in rural Oregon by leading decentralized clinical trials and building strong partnerships with local communities and primary care clinics. She works closely with rural practices and Oregon Health & Science University to expand access to clinical trials, with a particular focus on engaging underserved populations and promoting demographic diversity in research participation. With more than 17 years of experience in federally and industry sponsored research, Laura has managed a wide range of clinical trials teams in the Pacific Northwest. Her background also includes expertise in research ethics and regulatory compliance, having served as an administrator for multiple Institutional Review Boards.

Tesheia Harris

Tesheia Harris, M.B.A., M.H.S., is the founder, a Board of Directors member and the Chief Executive Officer for the Clinical Trials Access Collaborative (CTAC), an organization focus on expanding access to clinical trial innovation. Ms. Harris has more than two decades of visionary leadership, including developing, leading, and building successful programs at multiple Universities. Most recently she served as the Director of Clinical Research at the Yale School of Medicine, where she was instrumental in the development of the Yale Center for Clinical Investigation, a center specifically formed to catalyze and grow clinical research at Yale. After leaving Yale, Ms. Harris launched the Harris and Howard Consulting Group, a specialty practice focused on clinical research across multiple sectors, including academic medicine, large clinical practices, community hospitals, and private equity. Ms. Harris began her research career in the biotech industry before moving to academia. Ms. Harris's career has focused on the development of clinical research programs and supporting infrastructure. Over her career she has overseen the clinical research operations for thousands of single and multisite trials, including hundreds of national and international trials. Ms. Harris also has a remarkable series of accomplishments as a national leader in clinical research administration and program development, including the co-founding of the Cultural Ambassadors program, helping to shepherd many innovations in the use of technology including the EHR and research management systems, along with leading many national efforts. She served as the leader for the Yale MOU and partnership with the FDA Office of Minority Health and Health Equity and, along with the other Network Partners, developed and led the Equitable Breakthroughs in Medicine Development (EQBMED). Ms. Harris is a member of The National Academy of Sciences, Engineering and Medicine's Forum on Drug Discovery, Development, and Translation and serves as a member of the external scientific advisory boards for multiple CTSA institutions and the University College of London's Biomedical Research Center's Advisory Board. She was one of the team leaders for the Clinical Trials Transformation Initiative (CTTI) on clinical trials diversity. Most recently, she has co-authored the EQBMED Site Maturity Assessment Model, which is a holistic, collaborative, site-driven, and formative assessment carried out with potential sites to catalogue their current capabilities and identify opportunities for growth in conducting industry-sponsored clinical trials and enriching access of those trials.

Penny M. Heaton

Penny Heaton, M.D., is the Chief Medical Officer of Johnson & Johnson, where she leads efforts to address global health challenges, focusing on Medical Safety, Epidemiology, and Bioethics in alignment with the company’s Credo. She also heads the Communicable Diseases unit within J&J’s Innovative Medicine R&D, advancing the late-stage ExPEC vaccine program, supporting HIV products, and tackling infectious diseases that affect low-income countries. With over 20 years of experience in infectious diseases and vaccine development, Penny previously served as CEO of the Bill & Melinda Gates Medical Research Institute (Gates MRI), leading the development of investigational products for TB, malaria, and other diseases. She also worked as Director of Vaccine Development at the Gates Foundation, addressing diseases like HIV and polio. She began her career at the CDC, working on diarrheal disease surveillance and outbreak investigations, which sparked her passion for infectious diseases. Penny is a graduate of the University of Louisville School of Medicine, board-certified in Pediatrics, and a fellow of the American Academy of Pediatrics.

Patrik Johansson

Patrik Johansson, M.D., M.P.H., is a professor at Washington State University’s (WSU) Elson S. Floyd College of Medicine in the Department of Medical Education and Clinical Sciences. An internal medicine primary care physician by training, his work focuses on promoting the health of rural communities through research, teaching, and service. A past clinician in health professions shortage areas, he employs community-based participatory research methods to address chronic disease disparities in partnership with rural health clinics, critical access hospitals, American Indian-serving health care systems, rural public health departments, and other healthcare organizations. He also develops and implements public health curricula for practitioners and health-professions students while actively engaging them in research, not only to facilitate their learning about research methods but also to promote them to practice in health-professions shortage areas. Dr. Johansson received his M.D. from the University of Nebraska Medical Center College of Medicine and his MPH from the Harvard TH Chan School of Public Health. He has received a number of awards for his service, research, and teaching, including the Harvard Medical School Dean’s Community Service Award, the University of Nebraska Campus Compact “Outstanding Community and Campus Collaboration Award for excellence in community-based teaching and scholarship," and the Excellence in leadership award from the Nebraska Rural Health Association for his service as the association’s secretary from 2013 to 2017.

Marcus Johnson

Marcus R. Johnson, MPH, MBA, MHA is the Associate Director for the VA Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES). In this role, he provides executive leadership and strategic direction for this clinical research network which spans across 20 VA healthcare systems and 16 states and is an infrastructure that increases the accessibility of CSP research to Veterans across these sites of care. His primary interests are in developing strategies for increasing operational efficiencies in clinical research and healthcare management, and improving access to clinical research. Mr. Johnson received his master’s degree in public health (health behavior/health education) from the UNC Gillings School of Global Public Health and holds master’s degrees in business administration and health administration from Pfeiffer University. He has also served as adjunct faculty with the Department of Public Health, Brody School of Medicine, East Carolina University and the UNC Gillings School of Global Public Health.

Joseph K. Kaholokula

Joseph Keawe'aimoku Kaholokula is a professor and chair of Native Hawaiian Health at the John A. Burns School of Medicine. He is a clinical health psychologist and translational behavioral scientist who leads multiple federally funded research projects to improve Native Hawaiian/Pacific Islander health. He has leveraged community and cultural assets to develop culturally responsive health promotion programs to improve cardiometabolic health. He also oversees the Clinical and Translational Research Center of Pacific Innovations, Knowledge, and Opportunities He has served on the National Advisory Council on Minority Health and Health Disparities, Chaired the Intervention Research to Improve Native American Health, a network of National Institutes of Health-funded investigators working with American Indians, Alaska Natives, and Native Hawaiians, and co-Chaired the Asian American, Native Hawaiian, and Pacific Islander Interest Group of the NIH Community Engagement Alliance. He was recently elected into the National Academy of Medicine and continues to serve on the data disaggregation subcommittee of the White House Initiative on Asian Americans, Native Hawaiians, and Pacific Islanders. Dr. Kaholokula received his PhD from the University of Hawai’i Manoa as well as his MA in Clinical Psychology.

Esther Krofah

Esther Krofah, MPP, is the executive vice president of Health at the Milken Institute, leading FasterCures, Public Health, the Future of Aging, and Feeding Change. She has extensive experience managing efforts to unite diverse stakeholders to solve critical issues and achieve shared goals that improve patients’ lives. Most recently, Krofah was the director of public policy at GlaxoSmithKline (GSK), where she led engagement with the US Department of Health and Human Services (HHS) and relevant executive branch agencies on broad healthcare policy issues. Prior to GSK, Krofah was a deputy director of HHS’ Office of Health Reform. She also served as program director at the National Governors Association (NGA) healthcare division and worked in consulting at Deloitte Consulting LLP. Krofah received a BA from Duke University and a master’s in public policy from the Harvard University John F. Kennedy School of Government.

Ann E. Taylor

Ann Taylor, M.D., is a retired Chief Medical Officer at AstraZeneca. In this role, she was responsible for AstraZeneca’s global Patient Safety, Quality Assurance, and Regulatory Policy organizations, and the overall Benefit Risk assessment of our medicines. She is passionate about bringing the patient voice to everything we do. Prior to joining AstraZeneca in 2018, Dr. Taylor was Vice President and Global Head of the Program Office for the Novartis Institutes for BioMedical Research (NIBR). She also previously served as Global Head, Translational Medicine at NIBR, after having positions of increasing responsibility at Pfizer Global Research and Development. Dr. Taylor received her M.D. from Harvard Medical School, after receiving her B.A. in Biology magna cum laude from the University of California, San Diego. She completed her internship and residency in Internal Medicine, and her fellowship in Endocrinology and Metabolism at Massachusetts General Hospital, before joining the faculty there. Her research in the Reproductive Endocrine Unit at MGH focused on clinical neuroendocrinology of female reproductive disorders. At MGH, she also led a clinical research training program for students and residents. She has published over 45 journal articles. Dr. Taylor is passionate about excellence in clinical investigation, diversity in science, and leadership development.

Workshop

Engaging Community-Based Practices in Clinical Trials - A Workshop

July 14 - 15, 2026

Upcoming

About

An ad hoc planning committee of the National Academies of Sciences, Engineering, and Medicine will organize a public workshop on the opportunities and practical considerations for engaging community-based practices in clinical trials.
The public workshop may feature invited presentations and discussions on:

Opportunities for community-based practices to engage in clinical trials:

- Generating actionable evidence on relevant questions for drug research and development and improving patient care;
- Improving the relevance of clinical research for real-world practice;

Practical barriers (e.g., lack of infrastructure and workforce, contracting, institutional review boards) to engaging community-based practices, practitioners, and community sites (e.g., barbershops, beauty salons, and places of worship);
Considerations related to education, recruitment, and retention of the workforce in community-based practice settings;
Mechanisms to incentivize evidence generation by community-based practices across the clinical trials enterprise;
Short- and long-term goals for improving the efficiency, effectiveness, and person-centeredness of clinical trials in community-based practice settings.

Contact

Forum Staff

drugforum@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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Engaging Community-Based Practices in Clinical Trials - A Workshop