Inclusive Participation in Clinical Research Workshop

Thursday-Friday, March 30-31
11:00 a.m. – 5:00 p.m. ET

Workshop will be held virtually

The purpose of this workshop is to improve implementation of evidence-based best practices to increase inclusive participation in clinical research, with discussion on:

How to implement these practices
Challenges to overcome
Lessons learned

Workshop topics are organized by stage in the research process:

Before the study
During the study
After the study

Day 2 includes a special session featuring representatives from the different entities involved in supporting and conducting clinical research, such as academia, pharma, community-based organizations, and federal agencies.

The workshop will be recorded and available on this webpage approximately one month after the event.

Agenda

Day 1: March 30, 2023

All times listed are Eastern Daylight (UTC -4)

11:00 a.m. – 12:10 p.m.	Opening Session Moderators: Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD Welcome and Meeting Overview: Moderators Opening Remarks: Eliseo J. Pérez-Stable, M.D., NIMHD Overview of NIH Inclusion Efforts: Monica Webb Hooper, Ph.D., NIMHD; Janine Clayton, M.D., FARVO, NIH Office of Research on Women's Health Keynote Address: Otis Brawley, M.D., Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University Discussion/Q&A: Moderators
12:10 p.m. – 12:20 p.m.	Break
Session 1: Before the Study This session covers the planning and preparation that occurs before launching a study, including making recruitment plans, choosing a study site and research team members, and engaging with the community. Part 1 focuses on specific initiatives to address pre-study processes that impact diversity in clinical research. Part 2 focuses on specific aspects of the pre-study process.
12:20 p.m. – 1:40 p.m.	Part 1: Specific Initiatives Moderator: Yewande Oladeinde, Ph.D., NIMHD; Co-Moderator: Dawn Corbett, M.P.H., Office of the Director, NIH NIH All of Us Research Program: Making Precision Medicine a Reality for All: Martin Mendoza, Ph.D., NIH Office of the Director FDA Efforts to Advance Racial and Ethnic Minority Participation in Clinical Trials: RDML Richardae Araojo, Pharm.D., FDA Role of the Research Institution: Clinical Trials Transformation Initiative Report: Luther T. Clark, M.D., FACC, FACP, Patient Innovation & Engagement, Global Medical and Scientific Affairs, Merck Action and Accountability: Equity by Design: Willyanne DeCormier Plosky, DrPH, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Discussion/Q&A: Moderators
1:40 p.m. – 2:00 p.m.	Break
2:00 p.m. – 3:05 p.m.	Part 2: Specific Topics Moderator: Jennifer Alvidrez, Ph.D., NIH Office of Disease Prevention, NIH Office of the Director; Co-Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI Community Engagement: Developing the Relationship: Marvella Ford, Ph.D., M.S.W., M.S., Medical University of South Carolina Strategies Toward Social Justice: Inclusive Participation in the Clinical Research Enterprise: Bernadette Boden-Albala, Ph.D., University of California, Irvine Determining an Appropriate Study Population: Nicole Redmond, Ph.D., M.D., M.P.H., NHLBI Discussion/Q&A: Moderators
3:05 p.m. – 3:10 p.m.	Break
Session 2: During the Study This session covers the steps involved in conducting a clinical research study, starting with participant recruitment and ending with the final round of data collection and any follow-up procedures.
3:10 p.m. – 4:15 p.m.	During the Study Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI; Co-Moderator: Rebecca Favor, DrPH, CPH, NIH Office of Director Payment for Research Participation: Takeaways from OHRP's 2022 Exploratory Workshop: Natalie Klein, Ph.D., Office of Human Research Protections Community-Engaged Approaches for Equitable Representation in Research: Namratha R. Kandula, M.D., M.P.H, Northwestern University Feinberg School of Medicine Developing Trust: Engaging Referring Physicians as Partners in Health Care Research: Arch G. “Chip” Mainous III, Ph.D., University of Florida Discussion/Q&A: Moderators
4:15 p.m. – 4:30 p.m.	Closing Remarks How NIDCD is Advancing Inclusive Participation in Clinical Research: Debara Tucci, M.D., M.S., MBA, NIDCD Closing Remarks: What to Look Forward to for Day 2: Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD
4:30 p.m. – 5:00 p.m.	Networking Session Registered attendees are placed in Zoom break-out rooms with a list of suggested topics to guide discussion.
5:00 p.m.	Adjourn

Day 2: March 31, 2023

All times listed are Eastern Daylight (UTC -4)

11:00 a.m. – 11:05 p.m.	Welcome and Day 2 Overview Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD
Session 3: After the Study This session covers the activities that take place after data collection is completed, including data analysis and interpretation; communication of study findings via reports, peer-reviewed publications, and other forms of media; and translation of study findings into clinical practice.
11:05 a.m. – 12:10 p.m.	After the Study Moderator: Katrina Serrano, Ph.D., NIDDK; Co-Moderator: Jarrett Johnson, DrPH, M.S., NIMHD Improving Representation in Clinical Trials and Research - the 2022 National Academies Report: Kirsten Bibbins-Domingo, Ph.D., M.D., M.A.S., University of California San Francisco School of Medicine The Importance of Clinical Trials in Achieving Healthy Equity: Mona Fouad, M.D., M.P.H, University of Alabama-Birmingham School of Medicine Study Evaluation With Focus on Diversity and Inclusion Metrics: Leonard E. Egede, M.D., M.S., Medical College of Wisconsin Discussion/Q&A: Moderators
12:10 p.m. – 12:15 p.m.	Break
Session 4: Special Populations Panel Discussions These moderated discussions cover best practices for conducting clinical research with populations requiring special considerations, such as children, older adults, and pregnant and lactating persons. During each panel, the moderator asks questions in the first half that the panelists received in advance; panelists answer questions from the audience in the second half.
12:15 p.m. – 12:55 p.m.	Panel Discussion 1: Racial and Ethnic Minority Populations Moderator: Olufunmilola (Lola) Olufemi, Ph.D., NINDS; Co-Moderator: Jennifer Alvidrez, Ph.D., NIH Office of Disease Prevention, NIH Office of the Director American Indian and Alaska Native Populations: Denise A. Dillard, Ph.D., Southcentral Foundation and Washington State University Black/African American Populations: Lucile Adams-Campbell, Ph.D., Georgetown University Lombardi Comprehensive Cancer Center Hispanic/Latino Populations: Greg Talavera, M.D., M.P.H., San Diego State University College of Sciences Native Hawaiian and Pacific Islander Populations: Vaatausili “Va’a” Tofaeono, M.B.A., American Samoa Community Cancer Coalition Asian American Populations: May Sudhinaraset, Ph.D., UCLA Fielding School of Public Health
12:55 p.m. – 1:00 p.m.	Break
1:00 p.m. – 1:35 p.m.	Panel Discussion 2: Special Consent Considerations Moderator: Sonia Arteaga, Ph.D., NIH Environmental Influences on Child Health Outcomes (ECHO) Program; Co-Moderator: Katrina Serrano, Ph.D., NIDDK Children: Hengameh Heidarian-Raissy, Pharm.D., University of New Mexico School of Medicine Older Adults: Carrie Nieman, M.D., M.P.H., Johns Hopkins University School of Medicine Persons Who Are Incarcerated: Emily Wang, M.D., M.A.S., Yale University School of Medicine Persons With Limited English Proficiency: Tung Nguyen, M.D., University of California San Francisco School of Medicine
1:35 p.m. – 2:15 p.m.	Panel Discussion 3: Special Populations Moderator: Martin Mendoza, Ph.D., NIH All of Us Research Program; Co-Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI Sexual and Gender Minority Populations: Billy Caceres, Ph.D., R.N., FAHA, FAAN, Columbia University School of Nursing Pregnant and Lactating Persons: Sindhu K. Srinivas, M.D., MSCE, Hospital of the University of Pennsylvania Persons With Disabilities: Angel L. Miles, Ph.D., NIDILRR, Administration for Community Living Rural Populations: Gloria Coronado, Ph.D., Kaiser Permanente Center for Health Research Socioeconomically Disadvantaged Populations: Kali Zhou, M.D., M.A.S., Keck School of Medicine, University of Southern California
2:15 p.m. – 2:30 p.m.	Break
Session 5: Collaborator Perspectives Panel Discussion In these moderated discussions, representatives from the different entities involved in supporting and conducting clinical research offer their perspectives on how to increase the participation of individuals from underrepresented populations. During each panel, the moderator asks questions in the first half that the panelists received in advance; panelists answer questions from the audience in the second half.
2:30 p.m. – 3:05 p.m.	Panel 1: Community and Patient Perspectives Moderator: Karriem Watson, All of Us, NIH Office of the Director; Co-Moderator: Debbie Vitalis, Ph.D., M.P.H., NHLBI Community Organizations: Rev. Kendrick E. Curry, Ph.D., M.S., MDiv, Community Engagement Alliance (CEAL) Against COVID-19 Disparities Steering Committee and Pennsylvania Avenue Baptist Church; Ricki Fairley, M.B.A, TOUCH, The Black Breast Cancer Alliance Patient Advocacy Organizations: Shonta Chambers, M.S.W., Patient Advocate Foundation; Alissa Torres, M.S.W., Mental Health America
3:05 p.m. – 3:45 p.m.	Panel 2: Funder, Regulatory, and Policy Perspectives Moderator: Bob McNellis, M.P.A., P.A., NIH Office of Disease Prevention, NIH Office of the Director; Co-Moderator: Olga Herren, Ph.D., NIMHD Pharma: Brittany Gerald, B.S., Moderna Academia: Peter J. Embí, M.D., M.S., FACP, FACMI, FAMIA, FIAHSI, Vanderbilt University Medical Center Federal Agencies: Robert Califf, M.D., FDA Non-Federal Funders: Nakela L. Cook, M.D., M.P.H., Patient-Centered Outcomes Research Institute Policy and Advocacy Organizations: Eleanor (Ellie) Dehoney, M.P.H., Research!America
3:45 p.m. – 3:55 p.m.	Break
Session 6: Next Steps and Solutions In this session, speakers, attendees, and moderators engage in an interactive discussion about next steps and identify potential actional solutions for increasing inclusive participation in clinical research.
3:55 p.m. – 4:40 p.m.	Next Steps and Actionable Solutions for Inclusive Research Overview of What We Learned: Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD Open Discussion: Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD
4:40 p.m. – 4:55 p.m.	Closing Session Pulling It All Together – NIH Efforts in DEIA: Marie Bernard, M.D., Office of the Chief Officer for Scientific Workforce Diversity, NIH Office of the Director Thank You: Gina Roussos, Ph.D., NIMHD; Vanessa Marshall, Ph.D., CCRP, NIMHD
4:55 p.m.	Adjourn

Planning Committee:
Vanessa Marshall, Ph.D., CCRP (Co-Chair)
National Institute on Minority Health and Health Disparities (NIMHD)

Gina Roussos, Ph.D. (Co-Chair)
National Institute on Minority Health and Health Disparities (NIMHD)

Jennifer Alvidrez, Ph.D.
NIH Office of Disease Prevention (NIH ODP)

Dawn Corbett, M.P.H.
NIH Office of Extramural Research (NIH OER)

Deborah Jaffe, Ph.D.
National Cancer Institute (NCI)

Olufunmilola (Lola) Olufemi, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)

Nicole Redmond, M.D., Ph.D., M.P.H.
National Heart, Lung, and Blood Institute (NHLBI)

Katrina Serrano, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Debbie Vitalis, Ph.D., M.P.H.
National Heart, Lung, and Blood Institute (NHLBI)

Please send general questions about the workshop and specific questions for speakers or panelists to InclusiveClinResWksp@mail.nih.gov

Individuals who need reasonable accommodation to participate should indicate that when registering or by emailing InclusiveClinResWksp@mail.nih.gov at least five business days before the event.

Page updated March 21, 2023

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