Operational Metrics for the ELAINE II Study Combining a Traditional Approach With A Just-in-Time Model

ASCO 2022 Presentation
Authors Sibel Blau, Julio Peguero, Halle Moore, Ian Anderson, Minal Barve, Mathew Cherian, Ahmed Elkhanany, Ciara O’Sullivan, Alvaro Moreno-Aspitia, Paul Plourde, Lyon Gleich, Kendra Riesen, Ross Ezzati, Meghan Degele, Megan Shulman, Stephanie Dobson Stempf, Matthew M. Cooney, Senthil Damodaran

Background: Trial recruitment that requires specific actionable mutations based on next-generation sequencing (NGS) is challenging. Barriers can include competing studies, physician study awareness, site proximity, mutation incidence, among other concerns.

Methods: This study (NCT04432454) opened clinical sites using two methods during the COVID-19 pandemic. The “Traditional” approach included site selection, IRB and contract approval, and trial activation prior to a patient being identified for enrollment. The second approach used the Tempus “TIME” Trials network that would only open a site after identifying a patient with a mutation of interest and eligible for the trial.

Results: The first patient enrolled was on 10/12/20 and the last patient was on 6/24/21. A total of 16 sites (6 Traditional and 10 TIME) participated. All Traditional sites, and none of the TIME sites, were affiliated with major academic institutions. Duration for full CTA execution for Traditional sites averaged 200.5 days (range 142 to 257) and for TIME sites averaged 7.6 days (range 2 to 14). IRB approval time average for Traditional sites was 27.5 days (range 12 to 71) and TIME sites was 3.0 days (range 1 to 12 days). Days from site selection to activation letter for Traditional sites was on average 250.0 days (range 187 to 281) and for TIME sites was 131.6 days (range 22 to 248). Time from study activation to first consent was 33.3 days (range 18 to
58) for Traditional sites and 8.8 days (range 1 to 35) for TIME sites. The first patient on-study was at a TIME site 115 days prior to a Traditional site and the first 7 patients enrolled were at TIME sites. Traditional sites consented 23 and enrolled 16 patients while the TIME sites consented 16 and enrolled 13. The trial enrolled all 29 patients in 8 months with the anticipated enrollment duration being 12 to 18 months.

Conclusions: Although the Traditional and TIME programs had different operational models, they both contributed a significant number of patients and reduced the projected enrollment timeline. TIME sites enrolled the initial patients. These results demonstrate that the “Just-in-Time model,” in conjunction with a Traditional model, can reduce projected overall time to enrollment in biomarker-driven studies.

Number of Patients Enrolled at Clinical Sites by Month:

October 2020 2 0 2
November 2020 3 0 5
December 2020 0 0 5
January 2021 2 0 7
February 2021 1 2 10
March 2021 1 4 15
April 2021 0 4 19
May 2021 0 3 22
June 2021 4 3 29