Precise: A Clinical-Grade Automated Molecular Eligibility Screening And Just-In-Time (Jit) Physician Decision Support Solution For Molecularly-Selected Oncology Trials
JOURNAL OF CLINICAL ONCOLOGY(2018)
摘要
6507 Background: Clinical informatic systems that aid in identifying and matching actionable molecular alterations to the appropriate targeted therapies are critical for ensuring both the delivery of optimal routine care and the successful implementation of precision oncology research programs. We developed DARWIN PRECISE (PRECision Insight Support Engine), a clinical-grade informatics solution that identifies and dynamically tracks patients based on molecular and clinical data. PRECISE also provides JIT notifications to study teams and treating oncologists, facilitating patients’ seamless matching and enrollment to molecularly-selected trials. Methods: Under an IRB-approved study, we prospectively followed all patients identified by PRECISE and subsequently enrolled to molecularly-selected clinical trials at MSKCC between 16-April-2014 and 31-January-2017. Demographic, clinical, and molecular data were abstracted from the institutional data warehouse. Characteristics of therapeutic accruals facilitated by PRECISE were measured using descriptive statistics. Results: Patients treated by 150 unique oncologists and all accruals to 42 therapeutic trials that used PRECISE were included in the analysis. During the study period, a total of 742 patient-accruals occurred across the 42 trials. Of these, PRECISE prospectively identified 327 (44%) of accrued patients. Patients identified and subsequently enrolled by PRECISE harbored a wide variety (n = 32) of molecular alterations; with SNVs, CNAs, or fusions in ERBB2 (23.5%), PIK3CA (18.2%), BRAF (9.3%), and FGFR1/2/3 (6%) occurring most frequently. The median time from initial identification by PRECISE to trial consent was 82 days (IQR: 35-166), and the median time from tumor sequencing to consent was 161 days (IQR: 64-350). Conclusions: PRECISE facilitated the identification and enrollment of 44% (n = 327) of all patients accrued to molecularly-matched studies using this informatic platform. Automated JIT decision-support tools like PRECISE represent a novel and effective method for enhancing patient accrual to molecularly-selected therapies.
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关键词
molecular eligibility screening,physician decision support solution,oncology trials,clinical-grade,just-in-time,molecularly-selected
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