A technology-enabled clinical trial program’s impact on patient screening and trial enrollment in 2024.

Abstract

1506 Background: Typical workflows for clinical trial start-up and screening are time- and resource-intensive. The Tempus AI TIME program offers a novel clinical trial solution, collaborating with clinical sites to increase trial access and alleviate site burden by streamlining study activation and screening methods. Methods: The TIME program consists of an algorithmic trial screening platform (TApp), team of oncology nurses, diverse trial portfolio, and rapid study activation processes. Patient-level clinical information is centralized within the TIME database and includes structured and unstructured data generated from Electronic Medical Record integration, next generation sequencing results, and natural language processing models. The TApp used this data combined with trial eligibility criteria to algorithmically match patients to TIME trials. TApp searches were triggered by changes to study criteria and/or updates to clinical data. Algorithmic matches were filtered based on site capabilities, site interest in the trial, and trial lookback criteria, which defined the required recency of a patient's latest clinical document or encounter. Qualifying matches were then reviewed by a Tempus nurse and sent to sites if confirmed eligible. Trial activations followed TIME’s streamlined operational methods using a pre-negotiated rate card for site reimbursement of all clinical trial activities, standardized clinical trial agreement, and central IRB. Trials could be activated prospectively before the first eligible patient was identified, or in a “just-in-time” (JIT) manner if a patient was ready to consent. Data collected included TIME network information, TApp and nurse screening results, activation timelines, and enrollments across all active TIME sites and trials from 01/01/2024 - 12/31/2024. Results: During 2024, the TIME network consisted of 87 sites (79 Community, 8 Academic) and 98 trials. The TApp completed 1,323,259,353 searches across 1,281,676 patients resulting in 2,251,505 potential TApp trial matches. After applying site capability and trial lookback filters, TIME nurses screened 35,912 of these matches with 5,034 confirmed. These matches led to 186 activations (82 JIT, 104 prospective) and 573 consents. Conclusions: The Tempus AI TIME program facilitated the screening of 1.28M+ patients for over 95 clinical trials, averaging 1.57 consents per day over 1 year. Future trial matching strategies should utilize algorithmic screening and rapid activation processes to improve patient access and trial success. 2024 patient screening and consents. Patient Population 1,281,676 TIME Trials 98 TApp Searches 1,323,259,353 Algorithmic Matches 2,251,505 Matches Screened 35,912 Matches Confirmed 5,034 Interventional Consents 225 Observational Consents 348 Total Activations JIT: 82, Prospective: 104 Avg Activation Time (business days) JIT: 16.1, Prospective: 39.6