
Reaching Clinical Trial Excellence
Practical Strategies for Achieving Generalizable and Transportable Data
Friday, December 5th, 2025
7:00 - 10:00 AM EST
ASH Annual Meeting
Orange County Convention Center, Orlando
The Initiative
A DRIVE for Clinical Trial Excellence
D.R.I.V.E. is our strategic framework for promoting representative enrollment in clinical trials. This initiative addresses the inherent safety and efficacy concerns that arise when studies are conducted in populations that do not reflect the different patient groups these treatments are intended to serve. Generalizability, the ability to infer treatment effects for the entire population from a study population, and transportability, the ability to apply treatment effects from one group to another, are critical for ensuring equitable and effective care. To uphold these principles, we define “clinical trial excellence” as studies that successfully meet these diversity and representation benchmarks.
Despite growing awareness of these issues, most clinical trials remain unrepresentative, leading to data gaps that disproportionately impact minoritized populations. Historical migration patterns, systemic inequities, and biological factors such as genetic polymorphisms and microbiome diversity all contribute to varied treatment responses among different racial and ethnic groups. However, current trial designs often fail to account for these differences, resulting in regulatory approvals based on non-generalizable data. The D.R.I.V.E. Initiative 2025 aims to establish measurable standards for representation, advocate for policy changes, and promote inclusive research practices that improve clinical outcomes for all patients, regardless of background.
DRIVE Score Calculator
Our 2025 Speakers
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Hematology Oncology of Indiana, a Division of American Oncology Network
Partner
Indy Hematology Education Inc.
President and CEO
Marian University: Wood College of Osteopathic Medicine
Clinical Professor
Ruemu E. Birhiray, MD is an attending physician in medical oncology, hematology, and hematopoietic stem cell transplantation at Hematology-Oncology of Indiana, and at St. Vincent Hospital in Indianapolis, Indiana. After completing his internal medicine residency at Columbus Hospital in Chicago where he also served as Chief Medical Resident in 1994, he was a postgraduate fellow in bone marrow transplant at Johns Hopkins University in Baltimore and in medical oncology at the National Cancer Institute, National Institutes of Health in Bethesda, Maryland where his research included gene therapy and adoptive cellular immunotherapy strategies in bone marrow transplantation. Dr. Birhiray’s professional experience has also included serving as an attending physician, and Director of bone marrow transplantation and a member of Marshfield Clinic, Wisconsin and a Clinical Assistant Professor at the University of Wisconsin from 1998 to 2001. Additionally Dr. Birhiray was appointed an Associate Professor of bone marrow transplantation at Rush University, Chicago, Illinois in 2001, prior to joining Hematology Oncology of Indiana. Subsequently, Dr. Birhiray, served as and director of Bone Marrow Transplantation and Institutional Principal Investigator for the National Surgical Adjuvant Breast and Bowel Project of the National Cancer Institute at St. Vincent’s Hospital, Indianapolis. Currently, he is also, Clinical Professor, Marian University School of Osteopathic Medicine, Indianapolis, Indiana, and an Editorial Board Member of The Journal of Blood Transfusion and Hematopathology. Projects for which Dr. Birhiray is principal investigator include reduced intensity allogeneic transplantation in hematologic malignancies, and a trial of Interferon A, CHOP, and rituximab therapy in advanced-stage follicular lymphoma, and neoadjuvant chemotherapy for breast cancer. Additional collaborations have included major phase III clinical trials. Additionally Dr. Birhiray founded the Clinical research program at Hematology Oncology of Indiana. His awards include, “Intern of the year” from Columbus Hospital, Hope award from the Indiana Wellness community and named “best physician” by the Indianapolis monthly magazine and “top doctor” by Castle Connelly. In 2002, Dr. Birhiray founded and has served as Chair of the annual “Indy Hematology Review”, a nationally respected program providing education for hematologists and oncologists nationally and regionally, and he is also President and CEO of Indy Hematology Education, Inc. A member of the American Society of Clinical Oncology, the American Society of Hematology, and the American Medical Association, Dr Birhiray has published in the Journal of Clinical Oncology, Leukemia, Gene Therapy and Therapeutic Apheresis, Journal of Blood Transfusion and Hematopathology, Human Immunology, Familial Cancer, Annals of Pharmacotherapy, American Journal of Health System Pharmacists, Pharmacotherapy, in addition to multiple abstracts. Dr. Birhiray is married to Donna Marie (nee Baynard) since 1995, and they are blessed with 3 children, a daughter, Maya, born in 1999, and a son, Dirin, born in 2003, and an older daughter Meaghan who was born in 1990.
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Vanderbilt University Medical Center
Professor of Radiation Oncology
Ingram Professor of Cancer Research
Executive Director, Meharry-Vanderbilt Alliance
Dr. Karen Winkfield is a Professor in the Department of Radiation Oncology at Vanderbilt University Medical Center, Ingram Professor of Cancer Research at Vanderbilt Ingram Cancer Center, and Professor of Medicine at Meharry Medical College. She is the Executive Director of the Meharry-Vanderbilt Alliance, a strategic partnership between Meharry Medical College and Vanderbilt University Medical Center.
Prior to joining Vanderbilt, she was an associate professor of Radiation Oncology at Wake Forest University. Dr. Winkfield completed her residency training at Harvard and was a radiation oncologist at Massachusetts General Hospital Cancer Center prior to joining Wake Forest.
She specializes in the treatment of hematologic malignancies (lymphoma, leukemia, multiple myeloma, bone marrow transplantation) and breast cancer.
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Dana-Farber Cancer Institute and the HMS Center for Bioethics
Faculty Member
Assistant Professor of Medicine
Andrew Hantel, MD, MPH is an Assistant Professor of Medicine at Harvard Medical School and faculty member in the Divisions of Leukemia and Population Sciences at Dana-Farber Cancer Institute and the HMS Center for Bioethics. He received his MD from Loyola University Chicago; trained in internal medicine, adult hematology/oncology, and medical ethics at the University of Chicago; and completed a post-doctoral fellowship in cancer population sciences at the Dana-Farber/Harvard Cancer Center. Dr. Hantel's lab leverages health services and care delivery methods to address ethical dilemmas in cancer discovery and delivery. His current work focuses on equity in the contexts of research participation, artificial intelligence, and climate change.
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University of Pennsylvania: Perelman School of Medicine
Advisory Dean, Dr. Helen O. Dickens House
Ruth C. and Raymond G. Perelman Professor of Medicine
Professor of Biostatistics and Epidemiology
Carmen Guerra, MD, MSCE is the Ruth C. and Raymond G. Perelman Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania. She is also the Vice Chair of Diversity and Inclusion for the Department of Medicine and the Associate Director of Diversity and Outreach for the Abramson Cancer Center. Dr. Guerra leads Community Outreach and Engagement for the Abramson Cancer Center. In this role, she leads partnerships with community organizations to design, implement, and evaluate research and interventions to increase the participation of underrepresented populations in cancer screening research and clinical trials at the center.
Dr. Guerra is the PI of several studies aimed at increasing the participation of Black and Hispanic patients in cancer clinical trials, including the development and evaluation of the Abramson Cancer Center Clinical Trials Ambassador Program which provides peer-to-peer education to newly diagnosed breast cancer patients (funded by Bristol Myers Squibb Foundation and Genentech). She is a PI for a multi-site implementation study of the Lazarex Foundation’s Improving Patient Access to Cancer Clinical Trials (IMPACT), a patient financial reimbursement program for cancer clinical trial related travel expenses being conducted at the ACC, MD Anderson and UT Southwestern cancer centers. Dr. Guerra also co-led a national initiative by ASCO and ACCC that produced the first unconscious bias training for cancer researchers, Just Ask, and a site self-assessment instrument to support equity, diversity, and inclusion in clinical trials. Dr. Guerra is currently determining the impact of the Just Ask unconscious bias training in the recommendation of trials by breast cancer research teams.
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Indy Hematology Education, Inc.
Medical Science Liaison
Samuel Ranger, MS supports oncology education initiatives with a focus on equity, inclusion, and community-centered care. His professional interests include increasing diversity in clinical trials, advancing patient advocacy, and ensuring accessible, evidence-based cancer education for both providers and patients. Samuel holds both a Master’s and Bachelor’s degree in biology and is based in Fort Collins, Colorado, where he enjoys hiking, rock climbing, and exploring national parks.
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Indy Hematology Education, Inc.
Medical Science Liaison
Indiana University School of Medicine
First Year Medical Student