Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience

Angelique E. Boutzoukas, Rachel Olson, Mary Ann Sellers, Gwenyth Fischer, Chi D. Hornik, Omar Alibrahim, Kelechi Iheagwara, Kamal Abulebda, Andora L. Bass, Katherine Irby, Anjali Subbaswamy, Elizabeth E. Zivick, Jill Sweney, Anne G. Stormorken, Erin E. Barker, Riad Lutfi, Michael C. McCrory, John M. Costello, Kate G. Ackerman, Jennifer C. Munoz ParejaJ. Michael Dean, Nael Abdelsamad, Daniel F. Hanley, W. Andrew Mould, Karen Lane, Mary Stroud, Bryan J. Feger, Rachel G. Greenberg, P. Brian Smith, Daniel K. Benjamin, Christoph P. Hornik, Kanecia O. Zimmerman, Mara L. Becker

Research output: Contribution to journalArticlepeer-review

Abstract

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

Original languageEnglish (US)
Article number107067
JournalContemporary Clinical Trials
Volume125
DOIs
StatePublished - Feb 2023

Keywords

  • Clinical trial
  • Milestones
  • Pediatric trials
  • Study start-up

ASJC Scopus subject areas

  • Pharmacology (medical)

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