TY - JOUR
T1 - Approach to High Volume Enrollment in Clinical Research
T2 - Experiences from an All of Us Research Program Site
AU - Ilori, Titilayo O.
AU - Viera, Emma
AU - Wilson, Jillian
AU - Moreno, Francisco
AU - Menon, Usha
AU - Ehiri, John
AU - Peterson, Rachele
AU - Vemulapalli, Tejo
AU - StimsonRiahi, Sara C.
AU - Rosales, Cecilia
AU - Calhoun, Elizabeth
AU - Sokan, Amanda
AU - Karnes, Jason H.
AU - Reiman, Eric
AU - Ojo, Akinlolu
AU - Theodorou, Andreas
AU - Ojo, Tammy
N1 - Funding Information:
The All of Us Research Program at University of Arizona and Banner Health is funded by National Institutes of Health Award OT2OD026549 and UG3OD02317. Dr. Eric Reiman is also funded by National Institute of Aging (NIA) grant P30 AG19610. This project is dedicated to the entire staff of the All of Us Research Program at University of Arizona and Banner Health. We acknowledge all the contributions of the research staff, engagement coordinators, and support staff to the success of the UA-Banner Health Provider Organization.
Publisher Copyright:
© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - Clinical trials and cohort studies are required to meet target recruitment of study participants within stipulated timelines, especially when the priority is to include populations traditionally unrepresented in biomedical research. By the third quarter of 2019, the University of Arizona-Banner Health Provider Organization (UA-Banner HPO) has enrolled > 30,000 core participants into the All of Us Research Program (AoURP), the research cohort of the Precision Medicine Initiative. The majority of enrolled participants meet the criteria for individuals under-represented in biomedical research. The enrollment goals were calculated based on a target of 20,000 as set by the National Institutes of Health and our health provider organization achieved enrollment numbers between 17% and 86% above the targeted daily enrollment. We evaluated enrollment methods and challenges to enrollments encountered by the UA-Banner Health Provider Organization into the AoURP. Challenges to enrollment centered around the need for high-touch engagement methods, time investment necessary for stakeholder inclusion, and the use of purely digital enrollment methods especially in populations under-represented in biomedical research. These challenges occurred at the level of the individual, provider, institutions, and community, and cumulatively impacted participant enrollment. Successful strategies for engagement and enrollment leveraged provider partners as advocates for the program. For high-volume enrollment in clinical research, it is important to engage leaders in the healthcare setting, patient providers, and tailor engagement and enrollment to potential participant needs. We emphasize the need for precision engagement and enrollment methods tailored to individual needs.
AB - Clinical trials and cohort studies are required to meet target recruitment of study participants within stipulated timelines, especially when the priority is to include populations traditionally unrepresented in biomedical research. By the third quarter of 2019, the University of Arizona-Banner Health Provider Organization (UA-Banner HPO) has enrolled > 30,000 core participants into the All of Us Research Program (AoURP), the research cohort of the Precision Medicine Initiative. The majority of enrolled participants meet the criteria for individuals under-represented in biomedical research. The enrollment goals were calculated based on a target of 20,000 as set by the National Institutes of Health and our health provider organization achieved enrollment numbers between 17% and 86% above the targeted daily enrollment. We evaluated enrollment methods and challenges to enrollments encountered by the UA-Banner Health Provider Organization into the AoURP. Challenges to enrollment centered around the need for high-touch engagement methods, time investment necessary for stakeholder inclusion, and the use of purely digital enrollment methods especially in populations under-represented in biomedical research. These challenges occurred at the level of the individual, provider, institutions, and community, and cumulatively impacted participant enrollment. Successful strategies for engagement and enrollment leveraged provider partners as advocates for the program. For high-volume enrollment in clinical research, it is important to engage leaders in the healthcare setting, patient providers, and tailor engagement and enrollment to potential participant needs. We emphasize the need for precision engagement and enrollment methods tailored to individual needs.
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U2 - 10.1111/cts.12759
DO - 10.1111/cts.12759
M3 - Article
C2 - 32004412
AN - SCOPUS:85081934530
VL - 13
SP - 685
EP - 692
JO - Clinical and Translational Science
JF - Clinical and Translational Science
SN - 1752-8054
IS - 4
ER -