TY - JOUR
T1 - Operational Metrics for the ELAINE 2 Study Combining a Traditional Approach With a Just-in-TIME Model
AU - Blau, Sibel
AU - Peguero, Julio Antonio
AU - Moore, Halle C.F.
AU - Anderson, Ian Churchill
AU - Barve, Minal A.
AU - Cherian, Mathew Amprayil
AU - Elkhanany, Ahmed
AU - O'Sullivan, Ciara Catherine
AU - Moreno-Aspitia, Alvaro
AU - Plourde, Paul
AU - Gleich, Lyon L.
AU - Riesen, Kendra
AU - Ezzati, Ross
AU - Degele, Meghan
AU - Shulman, Megan
AU - Stempf, Stephanie Dobson
AU - Sachse, Laura
AU - Iyer, Amrita A.
AU - Damodaran, Senthil
AU - Cooney, Matthew M.
PY - 2023/6/1
Y1 - 2023/6/1
N2 - PURPOSE: There are numerous barriers to enrollment in oncology biomarker-driven studies. METHODS: The ELAINE 2 study (ClinicalTrials.gov identifier: NCT04432454) is an open-label phase 2 study of lasofoxifene combined with abemaciclib in patients with advanced or metastatic estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer with an ESR1 mutation. ELAINE 2 opened clinical sites by using a Traditional approach, which activated a site before patient identification, and the Tempus TIME Trial network, which opened a site only after identifying an eligible patient. This manuscript presents the operational metrics comparing the Traditional and TIME Trial site data. RESULTS: The study enrolled patients over 34 weeks and 16 sites (six Traditional and 10 TIME Trial) participated. Duration for full clinical trial agreement execution for Traditional sites and TIME Trial sites averaged 200.5 (range, 142-257) and 7.6 days (range, 2-14), respectively. Institutional review board approval time for Traditional sites and TIME Trial sites was 27.5 (range, 12-71) and 3.0 days (range, 1-12), respectively. Duration from study activation to first consent was 33.3 (range, 18-58) and 8.8 days (range, 1-35) for Traditional and TIME Trial sites, respectively. The first patient on study was at a TIME Trial site 115 days before a Traditional site and the first seven patients enrolled were at TIME Trial sites. Traditional sites consented 23 and enrolled 16 patients, while TIME Trial sites consented 16 and enrolled 13. The trial enrolled 29 patients in 8.5 months with the anticipated enrollment duration being 12-18 months. CONCLUSION: The TIME Trial network opened earlier and enrolled the first study patients. These results demonstrate that the Just-in-TIME model, along with a Traditional model, can improve enrollment in biomarker-driven studies.
AB - PURPOSE: There are numerous barriers to enrollment in oncology biomarker-driven studies. METHODS: The ELAINE 2 study (ClinicalTrials.gov identifier: NCT04432454) is an open-label phase 2 study of lasofoxifene combined with abemaciclib in patients with advanced or metastatic estrogen receptor-positive/human epidermal growth factor receptor 2-negative breast cancer with an ESR1 mutation. ELAINE 2 opened clinical sites by using a Traditional approach, which activated a site before patient identification, and the Tempus TIME Trial network, which opened a site only after identifying an eligible patient. This manuscript presents the operational metrics comparing the Traditional and TIME Trial site data. RESULTS: The study enrolled patients over 34 weeks and 16 sites (six Traditional and 10 TIME Trial) participated. Duration for full clinical trial agreement execution for Traditional sites and TIME Trial sites averaged 200.5 (range, 142-257) and 7.6 days (range, 2-14), respectively. Institutional review board approval time for Traditional sites and TIME Trial sites was 27.5 (range, 12-71) and 3.0 days (range, 1-12), respectively. Duration from study activation to first consent was 33.3 (range, 18-58) and 8.8 days (range, 1-35) for Traditional and TIME Trial sites, respectively. The first patient on study was at a TIME Trial site 115 days before a Traditional site and the first seven patients enrolled were at TIME Trial sites. Traditional sites consented 23 and enrolled 16 patients, while TIME Trial sites consented 16 and enrolled 13. The trial enrolled 29 patients in 8.5 months with the anticipated enrollment duration being 12-18 months. CONCLUSION: The TIME Trial network opened earlier and enrolled the first study patients. These results demonstrate that the Just-in-TIME model, along with a Traditional model, can improve enrollment in biomarker-driven studies.
UR - http://www.scopus.com/inward/record.url?scp=85162789662&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85162789662&partnerID=8YFLogxK
U2 - 10.1200/CCI.22.00164
DO - 10.1200/CCI.22.00164
M3 - Article
C2 - 37352479
AN - SCOPUS:85162789662
SN - 2473-4276
VL - 7
SP - e2200164
JO - JCO Clinical Cancer Informatics
JF - JCO Clinical Cancer Informatics
ER -