The Tempus TIME Trial Portal and Clinical Trial Enrollment

Authors Amol Rao, Kevin Miller, Chanh Trung Huynh, Rachel Luedtke, Mary Alice Anderson, Melissa Harris, Michael Johnstone, Lauren Murphy, Nicholas Morgan, Rachel Harmon, AnnaJane Ward, Blathnaid Donovan, Christie Rice, Scott Sherrin, Annie Darmofal, Danielle Skelly, Matthew M. Cooney

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.

Tempus TIME trials portal (2020-2022).
Data 2020 2021 2022 Total
Time Sites 31 55 71 71
EMR Integrated TIME Sites 14 23 30 30
Patients Added Total 365 1,691 4,789 6,816
Patients Added Monthly (Average) 48 141 399 219
Patients No Longer Trial Eligible 132 498 1,261 1,891
Patient Status Changes by TIME Team 542 2,081 6,020 8,643
Patient Updates by Clinical Sites N/A 1,285 6,157 7,442
Clinical Site Hours on TIME Trial Portal 0 352.3 879.4 1,231.7
Consents 20 252 351 623