Exploring New Inroads into Clinical Trial Diversity: Where Do We Go From Here?

September 26, 2023
1:00 pm-

2:30 pm

Virtual Event

Event Description

Clinical trials provide critical evidence for evaluating whether new drugs and treatments are safe and effective. Including a diverse and representative patient population in clinical trials is fundamental to ensuring that all communities benefit from innovation in medicine. 

New federal requirements which Congress enacted as part of the Food and Drug Omnibus Reform Act (FDORA) may help engage patients across a range of identities and racial and ethnic populations that have been historically excluded or underrepresented in research. As policymakers weigh additional options for advancing diversity in clinical trials, they may consider emerging strategies to reduce barriers to participation, increase trial accessibility, and support effective multi-sector collaboration.

This webinar provided an overview of new approaches for equitable clinical trial design, identified opportunities for leveraging technology and scaling community-based partnerships, and explored potential policy levers for promoting diversity and inclusion in clinical trials.

This virtual event was sponsored by Amgen, Patient-Centered Outcomes Research Institute (PCORI), Walgreens, and Genentech.

Speakers

Ricki Fairley, MBA

CEO and Co-Founder, Touch, The Black Breast Cancer Alliance
Ricki is an award-winning seasoned marketing veteran that has transformed her strategic acumen and vast consumer marketing expertise into breast cancer advocacy. Ricki co-founded and serves as CEO of TOUCH, The Black Breast Cancer Alliance to address Black Breast Cancer as a unique and special disease state, with the overall goal of reducing the mortality rate for Black women. Ricki founded and serves as co-host for “The Doctor Is In,” a weekly live breast cancer advocacy web series on the BlackDoctor.org Facebook page that reaches over 3 million viewers. She is a founding member of #BlackDataMatters, in partnership with Citizen, The Center for Health Care Innovation and Morehouse School of Medicine to encourage and elevate the importance of Black Women participating in clinical trial research. In January 2022, she started the When We Tri(al) Movement to change the game on Black women participating in clinical trials to improve outcomes for Black women with breast cancer with culturally humble and provocative communication that has resulted in thousands of Black women entering clinical trial research. She also actively assists pharmaceutical companies in revamping and designing their clinical trial recruiting materials. In support of her breast cancer work, Ricki serves on the Board of Trustees for the Triple Negative Breast Cancer Foundation where she chairs the marketing committee. She is a board member for the Center for Healthcare Innovation, and serves on the National Minority Quality Forum Scientific Advisory Board for Project Moonshot. She is a founding member of the American Cancer Society’s National Breast Cancer Roundtable Steering Committee. Prior to founding TOUCH, The Black Breast Cancer Alliance, Ricki was the Founder, and served as President and Thought Leader of DOVE Marketing, a marketing agency with a mission to deliver iconic thinking, strategic problem solving and creative genius to clients seeking profitable business results. Fairley is a seasoned marketer with 35+ years of marketing experience including 20 years in brand management at Johnson & Johnson, Nabisco, Reckitt & Colman, and The Coca-Cola Company, and over 15 years in agency leadership encompassing strategic planning and consulting for numerous Fortune 500 companies. She was passionate about helping clients identify marketplace opportunities, establish insight-based objectives and strategies, and build results-driven campaigns with resonating creative. Ricki holds the Leadership Award from the Creative Thinking Association of America and was named a Top 100 Marketer by Black Enterprise Magazine in February 2011.

Courtney Christian, MPA

Deputy Vice President, Policy and Research, Health Equity, Pharmaceutical Research and Manufacturers of America (PhRMA)
Courtney Christian is a Deputy Vice President of Policy and Research at PhRMA and leader of PhRMA’s Equity Initiative, driving a pioneering plan to invest in communities of color in three key pillars: enhancing clinical trial diversity, developing research and policies that advance health equity, and building a diverse industry talent pipeline. She also focuses on state-based reforms impacting health insurance, prescription drug coverage in public health programs. Prior to joining PhRMA, Courtney worked at the Black Women’s Health Imperative as Director of Policy and Advocacy, and on Capitol Hill for several years in a series of roles, culminating as Legislative Director for Rep. Kathy Castor (D-FL). Courtney is a Florida State football fan (and alum), aspiring chef, and mom to an energetic second grader.

Fabian Sandoval, MD

President and CEO, Emerson Clinical Research Institute (ECRI)
Dr. Fabian Sandoval, CEO & Research Director, has over 25 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine from the Autonomous University of Guadalajara, School of Medicine. Before opening the doors to Emerson Clinical Research Institute (ECRI) Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS) where he focused his work on Early Onset Alzheimer’s Disease, and Cretzfelt-Jakob Disease. At the NIHs’ Clinical Center conducting research in the outpatient Oncology unit, followed by his successful support of an NIH RO1 grant on preventing epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center, and Children’s National Medical Center. Dr. Sandoval served as the Supervisory Research Integrity & Compliance Officer in the Army Human Research Protections Office in the Office of the Army Surgeon General. Responsibilities included establishment, and oversight of Human Research Protection Programs across Army commands. His input has been instrumental in the review, development, and selection of protocols, in addition to education and training for resident and hospital faculty. Dr. Sandoval holds the following esteemed positions in the following community areas: • Four time Emmy Winner; Host of a one of kind weekly medical TV show “Tu Salud Tu Familia” (Your Family Your Health) • Medical Contributor for Telemundo, NBC, WZDC Washington D.C News, as well as Telemundo and Univision National. • Leadership Council member, Society for Clinical Research Sites (SCRS), • External Advisor to Genentech Roche • Renowned Invited Keynote speaker/presenter to multiple pharmaceutical and clinical trial organizations; on the topic of increasing minorities’ engagement, diversity education, and participation, in clinical trials. He has since started the Emerson Community Clinic, in order to support un-insured patients across the DC metro area, as well as starting the Emerson Diversity Health Foundation, who’s mission is to educate patients and providers in the importance of participating in clinical research and accesses to care.

Clay Alspach, J.D.

Principal, Leavitt Partners
Clay Alspach is a principal at Leavitt Partners specializing in federal health care policy and advocacy. At Leavitt Partners, Clay helps lead the Federal Insight and Advocacy Practice Area as well as a number of alliances. Before joining Leavitt Partners, Clay served as Chief Health Counsel for Chairman Fred Upton of the U.S. House of Representatives Energy and Commerce Committee. At the Committee, Clay spearheaded a number of legislative initiatives, including FDASIA, MACRA, DQSA, PAHPRA, and 21st Century Cures Act. Clay received his B.A. from the University of Richmond and J.D. from the University of Texas at Austin.

Craig Lipset

Co-Chair, Decentralized Trials & Research Alliance
Craig H Lipset Co-Chair, Decentralized Trials & Research Alliance Adjunct Assistant Professor, Rutgers University Vice President, Foundation for Sarcoidosis Research Managing Partner, Clinical Innovation Partners Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University, and serves on the Advisory Council for HL7 Project Vulcan and External Stakeholder Board for IMI Trials@Home. Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

Gary A. Puckrein, Ph.D.

President and CEO, National Minority Quality Forum
Dr. Gary Puckrein is the founding President and Chief Executive Officer of the National Minority Quality Forum (NMQF), a non-profit healthcare research, education, and advocacy organization headquartered in Washington, DC. The mission of NMQF is to reduce patient risk by assuring optimal care for all. NMQF conducts evidence-based, data-driven initiatives to eliminate premature death and preventable illness. NMQF’s vision is an American health services research, delivery, and financing system whose operating principle is to reduce patient risk for amenable morbidity and mortality while improving quality of life. Dr. Puckrein received his doctorate from Brown University.

Event Resources

Additional Reading

Additional Resources

Experts

Expert List

Anna Abram

Senior Advisor, Akin Gump Strauss Hauer & Feld LLP

Monica Baskin, PhD

Assistant Vice Chancellor for Community Health Equity, Health Sciences, University of Pittsburgh

Cameryn Blackmore, PhD

Health Policy Advisor, Office of Congresswoman Terri Sewell

Courtney Christian, MPA

Senior Director of Policy and Research, PhRMA

Craig Lipset, MPH

Advisor and Founder, Clinical Innovation Partners

Ricki Fairley, MBA

President and CEO, Black Breast Cancer Alliance

Lola Fashoyin-Aje, MD

Deputy Division Director and Associate Director, FDA Oncology Center of Excellence

Sally Okun, BSN, RN, MMHS

Executive Director, Clinical Trials Transformation Initiative

Karen Peterson 

Founder and Chief Patient Advocate, Karen’s Club

Gary A. Puckrein, PhD

President and CEO, National Minority Quality Forum 

Fabian Sandoval, MD

CEO and Research Director, Emerson Clinical Research Institute

Donald Warne, MD

Co-Director of Center for Indigenous Health, Johns Hopkins Bloomberg School of Public Health

Robert Winn, MD

Director and Lipman Chair in Oncology, VCU Massey Cancer Center 

Nora Wong, MPH

Legislative Liaison, National Institute on Minority Health and Health Disparities