TY - JOUR
T1 - Mechanisms to expedite pediatric clinical trial site activation
T2 - The DOSE trial experience
AU - Boutzoukas, Angelique E.
AU - Olson, Rachel
AU - Sellers, Mary Ann
AU - Fischer, Gwenyth
AU - Hornik, Chi D.
AU - Alibrahim, Omar
AU - Iheagwara, Kelechi
AU - Abulebda, Kamal
AU - Bass, Andora L.
AU - Irby, Katherine
AU - Subbaswamy, Anjali
AU - Zivick, Elizabeth E.
AU - Sweney, Jill
AU - Stormorken, Anne G.
AU - Barker, Erin E.
AU - Lutfi, Riad
AU - McCrory, Michael C.
AU - Costello, John M.
AU - Ackerman, Kate G.
AU - Munoz Pareja, Jennifer C.
AU - Dean, J. Michael
AU - Abdelsamad, Nael
AU - Hanley, Daniel F.
AU - Mould, W. Andrew
AU - Lane, Karen
AU - Stroud, Mary
AU - Feger, Bryan J.
AU - Greenberg, Rachel G.
AU - Smith, P. Brian
AU - Benjamin, Daniel K.
AU - Hornik, Christoph P.
AU - Zimmerman, Kanecia O.
AU - Becker, Mara L.
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2023/2
Y1 - 2023/2
N2 - Background: Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting. Methods: The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects. Results: Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation. Conclusion: Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved. ClinicalTrials.gov
AB - Background: Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting. Methods: The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects. Results: Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation. Conclusion: Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved. ClinicalTrials.gov
KW - Clinical trial
KW - Milestones
KW - Pediatric trials
KW - Study start-up
UR - http://www.scopus.com/inward/record.url?scp=85145693213&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85145693213&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2022.107067
DO - 10.1016/j.cct.2022.107067
M3 - Article
C2 - 36577492
AN - SCOPUS:85145693213
SN - 1551-7144
VL - 125
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107067
ER -