The Tempus TIME trial portal and clinical trial enrollment.

Abstract

1583 Background: The TIME Trial Program is a research network that screens > 1 million patients daily via EMR integrations and NGS testing through an automated trial matching platform and human review. There are enormous complexities following patients longitudinally as their clinical status changes while accurately matching them with hundreds of studies. The TIME Trials Portal, which stores both clinical trial documents and patient status updates, allows for real-time communication between the TIME team and Clinical Sites. Methods: After both an automated and nursing review, eligible trial patients are uploaded into the TIME Trials Portal. This database tracks the patient’s name, date of birth, biomarkers, clinical status, trial matches, free text comments, and upcoming physician, radiology, and laboratory appointments. To protect Personal Health Information, each Clinical Site can only view their own patients. Patient status is classified as Needs Review, Monitoring, Enrolled, Inactive. Each update is time-stamped and tracked. Enrolled patients have the trial name, consent date, and other pertinent information documented. Results: The data from 2020 to 2022 includes 71 TIME Sites. Over this period, 6,816 patients were added to the TIME Trials Portal for an average of 219 per month. Of these, 1,891 patients were no longer eligible due to worsening performance status, trial closure, death, and other causes. The TIME team provided 8,643 patient updates compared to 7,442 Clinical Site updates. Clinical Sites spent 1,231.7 hours using the TIME Therapies Portal resulting in 623 total consents. Data from 2022 alone, demonstrated that 30 (42.3%) Clinical Sites with EMR integrations were responsible for 4,491 (76.3% of the total) patient updates translating into 288 (82.1%) of all consents. Also in 2022, of the 27 (38%) Clinical Sites that updated their patient’s status > 50 times consented 291 (82.9% of the total) patients. Conclusions: By 2022, the TIME Trials Portal was averaging approximately 400 new patients monthly resulting in a 13.1X increase in patients added from the program’s inception. Clinical Sites updated the patient status over 7,400 times spending over 1,200 hours using the TIME Trials Portal. The highest-performing Clinical Sites, which enrolled approximately 80% of the total patients, included those with EMR integrations and/or > 50 patient updates yearly. The TIME Trials Portal enabled patient tracking and communication to facilitate clinical trial enrollment.[Table: see text]