Accrual of historically underrepresented patients with multiple myeloma using centralized screening in a multicenter study.
Abstract
e13709 Background: Patient (pt) identification, which is resource-intensive and time-consuming, can impede accrual to oncology trials, particularly in community settings. A centralized screening infrastructure may reduce site-level inefficiencies and accelerate accrual, while counteracting biases that have historically impacted trial representativeness. We evaluated the performance of an electronic health record (EHR)-based centralized trial screening service in a prospective multiple myeloma (MM) study, focusing on accrual of historically underrepresented racial and ethnic populations. Methods: We assessed the performance of a centralized screening infrastructure in a multicenter pilot study of daratumumab-eligible MM pts (n=50) at community practices. Pragmatic elements included broad inclusion/exclusion (I/E) criteria and a technology-enabled abstraction platform to facilitate pt identification. Trained specialists used this centralized, web-based platform to review EHR data and assess eligibility before scheduled visits. Real-time notifications for potentially eligible pts were issued via EHR alerts to study sites. Results: Between April-December 2024, 287 983 pts with an oncology visit in the next 60 days were centrally screened across 4 community oncology sites. Using structured I/E criteria from the EHR (eg, diagnosis, prior therapies) 99.4% of pts were excluded. When applying abstraction-based criteria to the remaining 1804 pts (eg, diagnosis confirmation, progression event), 178 (9.9%) were deemed eligible and 1253 (69.5%) were deemed to have a “watching” (no exclusionary variables but had not met all inclusion criteria) status. Automated data updates reevaluated status on the watch list. At data cutoff, 104 pts previously in “watching” were deemed eligible and included in the 178 pts meeting all criteria. Fifty eligible and “watching” pts consented to the study, and 49 initiated treatment. 28% of enrolled pts identified as Black or Latinx (see Table). Conclusions: These results support the implementation of a centralized, technology-enabled trial screening service with rapid pt accrual in the community oncology setting. The combination of structured data and abstraction-based screening improved accuracy by 90.1% (1626/1804) compared to structured data alone. This centralized screening service was associated with high participation of historically underrepresented participants, with the proportion of Black/Latinx pts enrolled reflective of pts treated at the study sites. Criteria Screened Pts, N Black/Latinx Pts, N (%) 1. Pts with a visit in 60 days 287 983 73 750 (25.6) 2. Pts meeting structured I/E criteria 1804 645 (35.8) 3. Pts with no exclusionary criteria after abstraction Eligible Eligible/Watching 1781431 64 (36.0)536 (37.5) 4. Pts who consented 50 (15 from Watching) 14 (28.0) 5. Pts treated on study 49 (15 from Watching) 14 (28.6)
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (17)
Anosheh Afghahi
Flatiron Health, New York, NY
Daniel P. Sanchez
Johnson & Johnson, Jacksonville, FL
Yichen Lu
Richard Michael Zuniga
New York Cancer and Blood Specialists, Babylon, NY
Laura Hester
1Johnson & Johnson, Horsham, United States
Dina Gifkins
1Johnson & Johnson, Raritan, United States
Britney Beaulieu
Flatiron Health, New York, NY
Catharine Cipolla
Flatiron Health, New York, NY
Barry Leybovich
Flatiron Health, New York, NY
Debra Mitchell
Johnson & Johnson Innovative Medicine, New Brunswick, NJ
Jeffrey Nan
Flatiron Health, New York, NY
Ebube Onwasigwe
Johnson & Johnson Innovative Medicine, New Brunswick, NJ
Hemang Patel
Johnson & Johnson Innovative Medicine, New Brunswick, NJ
Paul M Salcuni
Flatiron Health, New York, NY
Chloe Salzman
Flatiron Health, New York, NY
Neal J. Meropol
Flatiron Health, New York, NY
Ashita S. Batavia
Johnson & Johnson, Raritan, NJ