Conducting multicenter trials through the trial innovation network comprehensive consultation

Area of Science:

• Clinical Trials
• Translational Science
• Research Operations

Background:

• Multicenter clinical trials are essential for advancing patient care but face significant design and execution challenges.
• Investigator-initiated trials require robust support to ensure feasibility and success.
• The Clinical and Translational Science Award (CTSA) network comprises over 60 institutions.

Purpose of the Study:

• To evaluate the effectiveness of the Trial Innovation Network's (TIN) Comprehensive Consultation process.
• To assess the impact of structured, multidisciplinary support on the success of investigator-initiated multicenter clinical trial proposals.
• To demonstrate a scalable model for enhancing clinical research translation.

Main Methods:

• The study analyzed 75 trial proposals that received Comprehensive Consultation between 2016 and 2024.
• The consultation process utilized a phased Assess-Design-Compose model.
• Expertise integrated included trial design, operations, recruitment, and informatics.

Main Results:

• 66% of grant applications submitted after Comprehensive Consultation received funding.
• The consultation process facilitated the generation of robust and fundable grant applications.
• The TIN Comprehensive Consultation model proved effective in improving trial proposal quality.

Conclusions:

• The TIN Comprehensive Consultation process significantly enhances the rigor, efficiency, and success rate of multicenter clinical trials.
• This structured support model offers a scalable and high-impact approach for improving clinical research translation.
• The framework serves as a valuable model for national and global research networks.