Considerations in Launching an International Multisite Clinical Trial
Nurses must provide care that is supported by the best available evidence. Multisite RCTs are complex but provide high-quality evidence and can be managed with prospective systematic organization. In PROSpect, international sites took approximately twice as long to activate as U.S. sites. When developing a study start-up timeline, it is important to adjust milestones to accommodate the complexities of launching international sites and maintain momentum throughout the process, as start-up delays can increase the risk of trial failure. This paper contributes to recent efforts to demystify and streamline the multisite RCT start-up process for nurse investigators transitioning from conducting single-site to multisite trials.
Authors
- Laura Beth Kalvas (ORCID: https://orcid.org/0000-0001-9458-514X)
- Lisa A. Asaro (ORCID: https://orcid.org/0000-0001-5736-0304)
- Martha A. Q. Curley (ORCID: https://orcid.org/0000-0001-5228-6694)
- Laurie A. Lee (ORCID: https://orcid.org/0000-0002-0008-393X)
- Onella S. Dawkins-Henry (ORCID: https://orcid.org/0000-0003-0201-2913)
- David Wypij (ORCID: https://orcid.org/0000-0001-8367-8711)
- Mallory Perry (ORCID: https://orcid.org/0000-0001-5754-7857)
- Amy Cassidy
Institutions
- Twitter (United States) (US)
- Bethany College - West Virginia (US)
- Boston Children's Hospital (US)
- Nationwide Children's Hospital (US)
- University of Connecticut (US)
- University of Calgary (CA)
- Alberta Children's Hospital (CA)
- Connecticut Children's Medical Center (US)
- Orange County Public Schools (US)
- University of Pennsylvania (US)
Publication Details
- Journal
- Nursing Research
- Published
- 2025-04-04
- DOI
- https://doi.org/10.1097/nnr.0000000000000826
- Primary Topic
- Delphi Technique in Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00