Considerations in Launching an International Multisite Clinical Trial.

Area of Science:

• Nursing Research
• Clinical Trials
• Evidence-Based Practice

Background:

• Multisite randomized controlled trials (RCTs) are crucial for generating high-level evidence for nursing interventions.
• International multisite RCTs present significant logistical challenges, particularly regarding timely subject recruitment.
• Funders expect rapid subject enrollment, often within the first year of a trial's funding.

Purpose of the Study:

• To outline essential elements for initiating multisite RCTs.
• To provide a practical guide for nurse investigators transitioning to multisite research.
• To share lessons learned from a large international pediatric critical care RCT.

Main Methods:

• A step-by-step review of multisite RCT start-up activities.
• Utilizing the PROSpect international pediatric critical care RCT as an exemplar.
• Analyzing pre- and post-award activities, organizational structure, and launch timelines.

Main Results:

• 54 international sites initiated launch activities within two years; 28% began screening in year one.
• Subject enrollment commenced before the end of the first funding year.
• International sites took significantly longer to launch (median 448 days) compared to U.S. sites (median 219 days).

Conclusions:

• Multisite RCTs, while complex, yield high-quality evidence and can be managed with systematic organization.
• Adjusting timelines for international site activation is critical to mitigate risks of trial failure.
• Streamlining the multisite RCT start-up process is essential for nurse investigators.