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Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop (2020)

Chapter: Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists

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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Appendix B

Biographical Sketches of Workshop Moderators, Speakers, and Panelists

Emma Andrews, Pharm.D., is the senior director at Pfizer U.S./Global Medical Affairs, Women’s Health, with a focus on Pfizer’s menopause portfolio. Dr. Andrews joined Pfizer Worldwide Medical and Safety in 1999 and has held different positions with increasing responsibility in operations, research, and strategy, most recently as the regional medical therapeutic area lead of the Diversified Portfolio for Latin America, where she is responsible for developing medical strategies for Latin America and enhancing medical communication between Pfizer and the region’s stakeholders. Prior to that role, Dr. Andrews was a director in External Medical Affairs, responsible for engaging with external partners critical to Pfizer’s business with the goal of advancing areas of mutual interest. She was also a member of the Clinical Pharmacology team in New York, working in the infectious diseases therapeutic area, where her main focus was on HIV and malaria.

Dr. Andrews is a registered pharmacist in the state of Connecticut and a member of several health professional organizations. Born in Uganda, Dr. Andrews did her secondary education in Cote d’Ivoire and is trilingual, speaking English, French, and Luganda. She is a past president of the Jack and Jill Inc., Bridgeport, Connecticut, chapter, a position she held from May 2010 to May 2012. Dr. Andrews holds a B.S. in pharmacy and a Pharm.D. from the Massachusetts College of Pharmacy.

Connie Arnold, Ph.D., is a professor of medicine and a medical sociologist at Louisiana State University Health Sciences Center–Shreveport and the Feist-Weiller Cancer Center. Dr. Arnold has more than 26 years of experi-

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

ence conducting health literacy research and has 55 publications on health literacy, health communication and behavior, and preventive medicine. She has a productive record of federally funded research on developing and implementing low literacy interventions to improve health outcomes in vulnerable populations. Her wide-ranging work focuses on improving cancer screening in rural federally qualified health centers (FQHCs), self-management of diabetes in safety-net settings, and the use of health coaches to facilitate weight loss for patients using community clinics. Dr. Arnold is the principal investigator (PI) on a 5-year American Cancer Society health literacy intervention to evaluate follow-up strategies to improve regular colorectal screening in rural FQHCs in the state. She is a site PI and health literacy core co-director on a National Institutes of Health Institutional Development Award grant for the Louisiana Clinical and Translational Science Center, an unprecedented collaborative effort among 11 academic institutions in Louisiana. She is also a site PI on a Pennington Biomedical Center Patient-Centered Outcomes Research Institute–funded grant studying the comparative effectiveness of obesity treatment options delivered in primary care settings for underserved populations. Dr. Arnold has extensive experience working to simplify consent forms and patient education documents. She also has experience working with regional safety-net clinics, providers, and patients to develop and test literacy appropriate interventions.

Annlouise R. Assaf, Ph.D., M.S., FAHA, FISPE, is a pharmacoepidemiologist who is the patient health activation expert and global medical impact assessment senior director for Pfizer Worldwide Medical and Safety. In this role, she partners to evolve the science and practice of benefit–risk to inform better outcomes for patients, drug development, and health care decisions. A focus of her work is on quality benefit–risk communication and improving health literacy and patient-centered medication prescription so that patients can make informed, shared decisions about their treatment, as well as use their medications safely and appropriately, and improve value outcomes. Dr. Assaf is also a co-lead on the Health Literacy Working Group at Pfizer.

Dr. Assaf joined Pfizer in 2002 after many years in academic medicine and clinical research at the Brown University Medical School. She received her doctorate from the Roswell Park Cancer Institute in Buffalo, where she focused her research efforts in the fields of cancer and cardiovascular disease epidemiology with a particular focus on diseases that disproportionately affect women and patients with low health literacy.

Dr. Assaf was the co-principal investigator (PI) of the Pawtucket Heart Health Program, a community-based intervention for the prevention of cardiovascular disease, where she specialized in the evaluation of programs aimed at behavior change in low health literacy, low-income, and minority populations.

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

Dr. Assaf has been the PI or the co-PI for numerous National Institutes of Health clinical trials. She was a PI and Executive Committee member of the Women’s Health Initiative (WHI) Clinical Trial and Observational study and ran the largest of the 40 clinical centers of the WHI. She has served in numerous teaching, consulting, and leadership roles nationally and internationally and is currently a professor (adjunct) at the Brown University School of Public Health. She has published more than 100 scientific articles, book chapters, and abstracts.

Barbara E. Bierer, M.D., is a hematologist-oncologist and a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center) (www.mrctcenter.org), a collaborative effort to improve standards for the planning and conduct of international clinical trials. The MRCT Center is specifically focusing on health literacy in clinical research. In addition, Dr. Bierer is the director of the Regulatory Foundations, Ethics, and the Law program of Harvard Catalyst, the Harvard Clinical and Translational Science Award, working across the academic spectrum to enable clinical trials. She is the director of regulatory policy for SMART IRB (www.SMARTIRB.org), a national effort to align single-site Institutional Review Board reviews of multisite trials, and she co-founded Vivli (www.Vivli.org), a center for global clinical trial data sharing. From 2003 to 2014, Dr. Bierer served as the senior vice president, research, at BWH. During her tenure, Dr. Bierer founded and served as the executive sponsor of the Brigham Research Institute and the Brigham Innovation Hub (iHub), a focus for entrepreneurship and innovation in health care. She has authored more than 200 publications.

Dr. Bierer has been involved in policy development relating to the oversight of human research protection programs. She has been president of Association for the Accreditation of Human Research Protection Programs, served as chair of the U.S. Department of Health and Human Services’ Secretary’s Advisory Committee on Human Research Protections, and is currently a board member of Public Responsibility in Medicine and Research, Management Sciences for Health, Vivli, and the Edward P. Evans Foundation. Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.

Ebony Boulware, M.D., M.P.H., is a professor of medicine, the chief of the Division of General Internal Medicine in the Department of Medicine, the vice dean for translational science and the associate vice chancellor for translational research in the School of Medicine at Duke University. She received an A.B. from Vassar College, an M.D. from Duke University, and an M.P.H. from the Johns Hopkins Bloomberg School of Public Health.

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

Dr. Boulware attended medical school at Duke University, followed by residency and 1 year as chief resident in internal medicine at the University of Maryland. She then completed a research fellowship in general internal medicine at Johns Hopkins, where she remained on faculty for more than 10 years. In 2013, she was appointed the chief of the Division of General Internal Medicine in the Duke Department of Medicine. In 2015, she was appointed the director of Duke’s Clinical and Translational Science Award. Subsequently, she became the inaugural director of the Duke Clinical and Translational Science Institute.

Dr. Boulware has spent the majority of her scholarly career investigating mechanisms to improve the quality and equity of care and health outcomes for patients and populations with chronic diseases, such as chronic kidney disease and hypertension. Dr. Boulware’s research has been funded by numerous organizations, including the National Institutes of Health, the Patient-Centered Outcomes Research Institute, the Health Resources and Services Administration, the Agency for Healthcare Research and Quality, and foundations. She has published more than 120 manuscripts and has mentored numerous students, fellows, and faculty members in clinical research. Dr. Boulware frequently engages community members, patients, their family members, and other stakeholders to develop and implement relevant and sustainable interventions to improve health.

Deborah Collyar is the founder and president of Patient Advocates in Research (PAIR), an international communication network of patient advocates who work with research communities, advocacy organizations, and patients. The network covers multiple diseases, including cancers, rare diseases, and infectious diseases. In her current role, Ms. Collyar educates people about research and shares real patient experiences throughout the research process while helping to translate discoveries into clinical use. Ms. Collyar also founded the Clinical Trial Information Project, which helped cancer patients understand research studies and access open clinical trials, and which prompted the National Cancer Institute (NCI) to redesign its information system.

Ms. Collyar authored an e-book titled DCIS Dilemmas: Discussions About Ductal Carcinoma in Situ and Research Behind It and a blog called One Health of a Life, in addition to articles on patient advocacy and communication. She is also an editorial board member for the DIA Global Forum online monthly magazine, and does reviews for several journals.

Ms. Collyar volunteers with the Alliance for Clinical Trials in Oncology as the vice chair of the Publications Committee, and as a member of the Ethics, Health Outcomes, Experimental Therapeutics, and Patient Advocacy Committees. She was the first patient advocate in the NCI Clinical Trials Network and is a leader in public trial results summaries. She is

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

also a faculty member in the American Association for Cancer Research/American Society of Clinical Oncology Vail Methods in Clinical Research Workshop and the Society for Immunotherapy of Cancer Immunotherapy Winter School.

Terry C. Davis, Ph.D., is a professor of medicine and pediatrics in the Feist Weiller Cancer Center at the Louisiana State University Health Sciences Center in Shreveport, Louisiana. For the past 35 years, she has investigated the impact of patient literacy on health and health care, and she has more than 140 publications related to health communication. Her achievements include the development of the Rapid Estimate of Adult Literacy in Medicine and of user-friendly patient education and provider training materials that are used nationally. Dr. Davis has served on health literacy advisory boards for the American Medical Association and the American College of Physicians as well as on the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. She is a member of the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Health Literacy, Healthy People 2020, Health Literacy/Health Communication Section, and she serves on the U.S. Pharmacopeia Convention Expert Panel on Health Literacy. She received the Louisiana Public Health Association’s Founders Award for Significant Achievement in Public Health Research. Dr. Davis has a productive record of federally funded research on developing and implementing low literacy interventions to improve the health outcomes of vulnerable populations. Her wide-ranging work focuses on improving cancer screening in rural, federally qualified health centers; the self-management of diabetes in safety net settings; the use of health coaches to facilitate weight loss in community clinics; and improving prescription medication labeling.

Lauren McCormack, Ph.D., M.S.P.H., is the vice president of RTI’s Public Health Research Division and an adjunct associate professor at the University of North Carolina (UNC) Gillings School of Global Public Health. Her research bridges the fields of health communication and health policy and involves developing, testing, and evaluating interventions to promote patient-centered care, patient engagement, and informed decision making. An overarching goal of her work is to improve the public’s understanding and use of medical evidence in health care decision making. Dr. McCormack is the principal investigator of a 5-year, $9 million pragmatic trial examining the comparative effectiveness of two behavioral interventions focused on opioid use and the management of chronic pain. This study, funded by the Patient-Centered Outcomes Research Institute (PCORI), is a collaboration with Duke University, UNC at Chapel Hill, and Vanderbilt University, and leverages the PCORnet Clinical Data Research Network. She recently completed a study to assist the U.S. Food and Drug Administration (FDA)

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

in enhancing its communications about opioids to both the lay public and health care professionals, and she has provided consultative services to FDA on drug safety messaging. From 2015 to 2018, Dr. McCormack served as chair of PCORI’s Clinical Effectiveness and Decision Science Advisory Panel and recently completed a commissioned chapter for the National Academies of Sciences, Engineering, and Medicine on health literacy. She developed a skills-based measure of health literacy and was a guest editor of a series of special issues of the Journal of Health Communication focused on health literacy. Dr. McCormack has published more than 60 peer-reviewed manuscripts and multiple book chapters, and she is a frequent presenter at domestic and international conferences.

Monika Mitra, Ph.D., M.A., M.Sc., is the Nancy Lurie Marks Associate Professor of Disability Policy and director of the Lurie Institute for Disability Policy at Brandeis University. She is also adjunct associate professor in the Department of Family Medicine and Community Health at the University of Massachusetts Medical School. Her research examines the health care experiences and health outcomes of people with disabilities, with a particular focus on the sexual and reproductive health of women with disabilities. Her current research revolves around the health needs and barriers to perinatal care among women with disabilities, including women with intellectual and developmental disabilities and deaf and hard-of-hearing women. She is currently co-leading the National Research Center for Parents with Disabilities, with a focus on addressing knowledge gaps regarding the needs of parents with diverse disabilities, and the Community Living Policy Center, aimed at improving policies and practices that advance community living outcomes for people with disabilities. Dr. Mitra is a member of the Disability and Health Journal editorial board and of the Advisory Committee of the Academy Health Disability Research Interest Group.

Catina O’Leary, Ph.D., M.S.W., is the president and the chief executive officer of Health Literacy Media (HLM). Accordingly, she oversees HLM’s core activities, including the Clearly Communicating Clinical Trials program, and she works to set and maintain the strategic vision for the organization. Dr. O’Leary has steered the organization onto the course of becoming a true partner to a broad spectrum of health care organizations around the world. A primary goal is to empower people with health information they can actually use.

Prior to joining HLM, for more than a decade Dr. O’Leary led research at the Washington University School of Medicine with a focus on connecting people at risk for health conditions such as HIV and other sexually transmitted infections, and with medical and social resources aimed at improving health behaviors, preventing illness, and improving overall

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

health and well-being. During that time, Dr. O’Leary led multisite clinical trials in the United States and internationally. She was actively engaged in every phase of the research process—writing grants to federal agencies and foundations; developing protocols for submission to obtain and maintain Institutional Review Board approval across multiple sites; hiring and training staff for data collection and intervention implementation; and leading data analysis, reporting, and research dissemination.

While at Washington University, Dr. O’Leary was an active member of the Human Research Protection Office’s (HRPO’s) continuing review committee. Currently, she serves on Washington University’s HRPO consent task force, which is focused on adjustments to the university’s consent process. She also participates on the Multi-Regional Clinical Trails Center of Brigham and Women’s Hospital and Harvard’s Health Literacy Workgroup, which is focused on health-literate communication of clinical research information.

Phyllis J. Pettit Nassi, M.S.W., is an Alliance for Clinical Trials in Oncology patient advocate serving on the Patient Advocate, Health Disparities, and Pharmacogenetics and Population Pharmacology Committees; an Advocate in Science member for Susan G. Komen for the Cure; co-chair of the Southwest Region of the Intercultural Cancer Council Network; and a member of the American Association for Cancer Researchers. Enrolled in the OtoeMissouri tribe, a member of the Cherokee Nation, Ms. Pettit Nassi is the associate director for Research and Science, Special Populations, American Indian Program at the Huntsman Cancer Institute at the University of Utah. Raised on the Navajo, Hopi, and Zuni reservations and experienced in scientific research, outreach, development, and implementation of research projects, Ms. Pettit Nassi is well aware of the need for cultural humility and awareness and works with research teams to understand “how complicated it’s going to be to get it right, and how difficult it will be for every researcher working with Native American people if they get it wrong.” Formerly a Ph.D. student at the University of Utah’s College of Social Work, her focus is on health disparities; the medically underserved of rural and frontier populations; and cancer research education, screening, and early detection. Educating tribal populations about the importance of participating in clinical trials and ensuring their understanding of the future direction of cancer research (e.g., genomics) and data sharing will improve and bring equity to the research table. She has studied cultural and social implications on underserved populations for more than 30 years.

Saira Z. Sheikh, M.D., is an assistant professor of medicine at the University of North Carolina (UNC) at Chapel Hill, the director of the UNC Rheumatology Lupus Clinic, and the director of clinical trials programs at

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

the UNC Thurston Arthritis Research Center. She came to UNC after residency and chief residency in internal medicine at the University of Arizona, and she completed fellowships in rheumatology and allergy immunology at UNC. She is board certified in internal medicine, rheumatology, and allergy and immunology. Her work focuses on answering scientific questions that directly impact the care of patients with lupus and Sjogren’s syndrome.

Dr. Sheikh is the principal investigator (PI) on numerous clinical trials evaluating novel therapeutics in lupus. She is leading national initiatives to develop real-world, practical models to improve the education of patients and to change providers’ practices to promote inclusion of minority patients in lupus clinical trials, including working with the American College of Rheumatology, funded by the U.S. Department of Health and Human Services’ Office of Minority Health. Dr. Sheikh is the co-PI of the Patient Advocates for Lupus Studies program through Lupus Therapeutics, an innovative peer-to-peer educational program, in which patient education is delivered by trained patient advocates who have personal experience with clinical trials.

Dr. Sheikh is interested in using technology-based applications to improve understanding about clinical trials, and at UNC she is leading project PURPLE (Programs to Address Unmet Needs and Promote Representation of All Participants in Lupus Clinical Trials Using Mobile Technology for Engagement). She is actively involved in the education of medical students, residents, subspecialty fellows, and patients.

Lawrence G. Smith, M.D., MACP, is Northwell Health’s physician-in-chief. As physician-in-chief, he is Northwell Health’s senior physician on all clinical issues. He previously served as Northwell’s chief medical officer. Dr. Smith is also the founding dean of the Donald and Barbara Zucker School of Medicine, which received full accreditation by the Liaison Committee on Medical Education and whose first class graduated in May 2015. Dr. Smith joined Northwell in May 2005 as the chief academic officer and the senior vice president of academic affairs. In this capacity, Dr. Smith strengthened Northwell’s graduate medical education programs and expanded its medical school affiliations, significantly enhancing Northwell’s ability to recruit medical students and residents. In addition, Dr. Smith was responsible for overseeing Northwell’s medical student education programs and academic faculty appointments. He was also accountable for establishing close relationships with doctors and hospitals throughout Northwell, which enhanced its partnerships with staff and community-based physicians and improved physician recruitment efforts.

Before joining Northwell, Dr. Smith was at the Icahn School of Medicine at Mount Sinai in Manhattan, where he served as the dean (beginning in 2002) and the chair of medical education, the founder and the director of

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

the school’s Institute for Medical Education, a professor of medicine, and an attending physician. He joined the faculty of the Mount Sinai School of Medicine in 1994 as the vice chair of the Department of Medicine and residency program director. Prior to his career at Mount Sinai, Dr. Smith practiced general medicine at Stony Brook University Hospital, where he became a full-time faculty member, the director of education, and the program director of the hospital’s residency program in internal medicine. He began his career practicing general internal medicine in Huntington, New York. Dr. Smith has held senior leadership positions in national societies for medical education and residency training, has authored numerous peer-reviewed publications in the area of medical education, and has received many awards and honors from national and international organizations. He is a member-at-large of the National Board of Medical Examiners and is a member of the Board of Visitors of Fordham College. Also, he is a former regent of the American College of Physicians and a former member of the board of directors of the American Board of Internal Medicine. In April 2011, Dr. Smith was elected to Mastership of the American College of Physicians.

Dr. Smith is the first recipient of the Lawrence Scherr, M.D., Professorship of Medicine at the Zucker School of Medicine. He was honored with the 2008 Dema C. Daly Founders Award by the Association of Program Directors of Internal Medicine, of which he is a former president. In addition, he was awarded the Solomon A. Berson Alumni Achievement Award in Health Science by the New York University School of Medicine. Dr. Smith earned a B.S. in physics from Fordham University and an M.D. from the New York University School of Medicine. His residency in internal medicine at Strong Memorial Hospital was followed by military service as a captain in the Army Medical Corps at Fitzsimmons Army Medical Center in Denver.

Patty Spears is a 19-year breast cancer survivor and cancer research advocate. Ms. Spears has extensive clinical trial advocacy experience, having served as an advocate on the Translational Breast Cancer Research Consortium and on the National Cancer Insitute Breast Cancer Steering Committee. She is also an associate group chair for advocacy of the Alliance for Clinical Trials in Oncology (a National Clinical Trial Network group) and the chair of the Alliance Patient Advocate Committee. She is a Komen Scholar, serves as the co-chair on the Komen Advocates in Science Steering Committee, and is a U.S. Food and Drug Administration patient representative. She leads the University of North Carolina (UNC) Lineberger Patient Research Advocacy Group and the UNC Breast Specialized Program of Research Excellence Advocates. At UNC, she focuses on communicating science and clinical research to the public and facilitating the engagement of patients with basic and clinical researchers. She also has an interest in

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

patient-reported outcome measurements in drug development. Ms. Spears is currently working as a scientific research manager and a patient advocate at the UNC Lineberger Comprehensive Cancer Center.

Jovonni R. Spinner, M.P.H., CHES, is a public health strategist and thought leader with a deep passion for improving health equity across the lifespan through research, communication, multisector partnerships, and leadership coaching. She is known as a public health programming guru who uses her skills to direct projects from concept to fully operational through program design, implementation, monitoring, and evaluation, and by breaking down silos across sectors.

At the U.S. Food and Drug Administration (FDA), she is the lead for the outreach and communications team in the Office of Minority Health, where she oversees the strategic direction of the team, advises senior officials on minority health, and leads the Diversity in Clinical Trials Initiative. Prior to joining FDA, she managed national initiatives, including the Community Health Worker Health Disparities Initiative at the National Heart, Lung, and Blood Institute at the National Institutes of Health, which aims to reduce cardiovascular and asthma health disparities through community education and training. She also provided health policy guidance to leaders on vaccine supply and finance policy issues at the U.S. Department of Health and Human Services’ National Vaccine Program Office, and served as the director of Virginia’s Vaccines for Children Program, ensuring that the state’s Medicaid, uninsured, and underinsured populations were vaccinated.

Ms. Spinner serves on nonprofit boards at the American Public University System and the Society for Public Health Education, and writes women’s health articles for Health in Her Hue. Ms. Spinner received her B.S. in biology from Virginia Commonwealth University, her M.P.H. from the Rollins School of Public Health at Emory University, and is pursuing her Dr.P.H. from Morgan State University.

Alicia Staley is the senior director for patient engagement for mHealth at Medidata. She has more than 20 years of experience in software design and information systems management and works to infuse the patient perspective throughout the product development life cycle and to help engage patients in novel ways.

Ms. Staley is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. Over the past 10 years, she has applied her engineering background to improve the patient experience for those dealing with cancer. With an extensive network of patient advocates and nonprofit organizations, she collaborates with a wide range of stakeholders to improve processes and policies that affect patient care and

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

clinical trials. She has co-led several research studies on how patients both share information in online forums and seek out clinical trial opportunities.

An early adopter of social media, she co-founded #BCSM (the Breast Cancer Social Media community), which attracts more than 250 global participants each week to its scheduled online discussions. This foundational online social media support channel is recognized as the gold standard for disease-specific social media networks.

Prior to joining Medidata, Ms. Staley worked at Cure Forward and Science 37, leading their patient recruitment and engagement initiatives to help advance clinical research. As a champion of patient advocacy and engagement, she understands the critical issues facing patients looking to engage in clinical research. With a keen focus on improving access to clinical trials, Ms. Staley is passionate about making a difference for all patients searching for information about clinical trials.

Christopher R. Trudeau, J.D., has a dual appointment at both the University of Arkansas for Medical Sciences (UAMS) and the Bowen School of Law at the University of Arkansas at Little Rock. In his role at Bowen, Professor Trudeau teaches Research, Writing, and Analysis I and II. He has extensive experience teaching legal writing, having taught legal writing to more than 1,500 students during his 13-year tenure at the Western Michigan University–Thomas M. Cooley Law School. While there, Professor Trudeau taught every legal writing course the school offers, and he has become an international leader in plain-language legal writing and drafting. In 2012, Professor Trudeau published the first U.S. study to measure the public’s preferences for legal communication, and he has recently received a grant from the Legal Writing Institute, the Association of Legal Writing Directors, and Lexis/Nexis to conduct a similar international study. As an associate professor at the UAMS Center for Health Literacy, he conducts empirical research on clear health communication, drafts health care documents, and teaches health law and communication courses to medical students and students in other health professions. Professor Trudeau is a leading expert on health literacy, informed consent, and risk communication. He often speaks on how to communicate legal and health information in ways that both engage patients and better protect health care organizations. Professor Trudeau frequently speaks on these topics, most recently at the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and the National Academies of Sciences, Engineering, and Medicine.

Consuelo H. Wilkins, M.D., MSCI, is the recently appointed vice president for health equity at the Vanderbilt University Medical Center and is the associate dean for health equity at the Vanderbilt University School of Medicine. Dr. Wilkins is a clinical investigator and an engagement

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×

researcher who is an associate director of the Vanderbilt Institute for Clinical and Translational Science, where she oversees programs in community engagement and team science. Dr. Wilkins is a principal investigator of the Vanderbilt-Miami-Meharry Center of Excellence in Precision Medicine and Population Health, which focuses on decreasing disparities among African Americans and Latinos using precision medicine, and at the Vanderbilt Recruitment Innovation Center, a national center dedicated to enhancing recruitment and retention in clinical trials. She is widely recognized for her innovative work on developing and testing methods and tools to engage patients and communities in research. She serves as the director of the Engagement Core of the All of Us Research Program, a national precision-medicine project that will enroll 1 million or more participants. In the interim, Dr. Wilkins also continues to serve as the executive director of the Meharry–Vanderbilt Alliance. She holds faculty appointments as an associate professor of medicine at both the Vanderbilt University Medical Center and Meharry Medical College. Prior to her current roles, Dr. Wilkins was an associate professor in the Department of Medicine, Division of Geriatrics, with secondary appointments in psychiatry and surgery (Public Health Sciences) at the Washington University School of Medicine in St. Louis. She served as the founding director of the Center for Community Health and Partnerships in the Institute for Public Health, the co-director of the Center for Community Engaged Research in the Clinical Translational Science Awards, and the co-founder of Our Community, Our Health, a collaborative program with St. Louis University, to disseminate culturally relevant health information and facilitate community–academic partnerships to address health disparities.

Rebecca J. Williams, Pharm.D., M.P.H., is the acting director at ClinicalTrials.gov at the National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health in Bethesda, Maryland. She moved into this role after serving as the assistant director of ClinicalTrials.gov for more than a decade. She is responsible for technical, scientific, policy, regulatory, and outreach activities related to the operation of ClinicalTrials.gov, an international registry-and-results database of clinical research. Her research interests relate to improving the quality of reporting for clinical research. Her prior experience includes serving as a regulatory affairs consultant and a reviewer and in supervisory roles at the U.S. Food and Drug Administration in the area of prescription drug advertising and promotion. She received her Pharm.D. from the University of Wisconsin–Madison and her M.P.H. from the Bloomberg School of Public Health at Johns Hopkins University.

Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
×
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Page 98
Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Page 99
Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Page 100
Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Suggested Citation:"Appendix B: Biographical Sketches of Workshop Moderators, Speakers, and Panelists." National Academies of Sciences, Engineering, and Medicine. 2020. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25616.
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Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop Get This Book
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Because of the individualized nature of drug and therapeutic treatments, clinical trials require participants who represent the diversity of the patient base. If early trials do not have a broad patient base, it can be difficult to know who may or may not benefit from or respond to a treatment later. In addition to diversity in recruitment, informed consent during participation is also crucial. If participants do not fully understand what they are signing up for, they may become confused, mistrustful, or drop out of a trial altogether, confusing investigators and possibly affecting the generalizability of a study.

To explore the incorporation of health literacy practices into clinical trials, the Roundtable on Health Literacy convened a workshop titled Clinical Trials: Practice and Impact on April 11, 2019, in Washington, DC. The workshop presentations and discussion centered around issues related to the challenges or barriers for diverse populations' participation in clinical trials, best practices for clinical trial sites and researchers incorporating health literacy practices, and effective health literacy strategies for clear communication with participants. This publication summarizes the presentation and discussion of the workshop.

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