Insights from the trial innovation network’s initial consultation process

TL;DR

The Trial Innovation Network helps improve multicenter clinical trials by providing free expert consultations to enhance trial design and efficiency.

Contribution

The TIN's Initial Consultation process offers a novel framework for improving trial design through expert input and standardized processes.

Findings

The TIN has provided 431 initial consultations as of June 2024, improving trial efficiency.

Standardized processes were developed across a range of clinical trials.

Operational metrics and lessons learned are shared to guide other trial innovation networks.

Abstract

Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health’s National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial’s duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator’s institution. The Initial Consultation process focuses on the study’s scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.

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