Challenges Associated with Managing a Multicenter Clinical Trial in Severe Burns

Area of Science:

• Critical Care Medicine
• Nephrology
• Clinical Trial Management

Background:

• Managing multicenter clinical trials (MCTs) presents significant logistical and administrative challenges.
• The Randomized controlled Evaluation of high-volume hemofiltration in adult burn patients with Septic shoCk and acUte kidnEy injury (RESCUE) trial aimed to assess high-volume hemofiltration in critically ill patients.

Purpose of the Study:

• To review the obstacles encountered and lessons learned during the coordination of the RESCUE trial, a prospective multicenter clinical trial.
• To highlight key factors necessary for the successful execution of complex clinical research.

Main Methods:

• The RESCUE trial was a prospective multicenter clinical trial involving ten US burn centers.
• Enrollment targeted 120 subjects, with a study team including site personnel, a data coordination center, and multiple committees.
• The manuscript details challenges faced from grant award to subject enrollment and trial cessation.

Main Results:

• The RESCUE trial experienced significant delays, with enrollment starting 29 months after grant award and stopping after only 37 subjects were enrolled across seven sites.
• Obstacles included institutional review board changes, complex review processes, staffing fluctuations, and contract finalization issues.

Conclusions:

• Successful multicenter clinical trials necessitate robust research teams, adequate patient populations, specialized expertise, and essential infrastructure.
• Establishing realistic timelines and proactive strategies to address inevitable challenges, alongside continuous communication among all stakeholders, are crucial for trial success.