The Clinical and Translational Science Award (CTSA) program recently established the Trial Innovation Network as a resource for investigators to request consultations and services for multi-center clinical trials.
The vision for the Trial Innovation Network is to innovatively address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies. The Trial Innovation Network is a collaborative national network that focuses on operational innovation, operational excellence and collaboration and leverages the expertise and resources of the CTSA Program.
The goal of the Trial Innovation Network is to provide a new model for multi-center clinical trials and a flexible resource that allows investigators to choose from a menu of basic consultations and services or comprehensive consultations. In addition, it is anticipated that the Trial Innovation Network will not only execute trials better, faster and more cost-efficiently than what is currently the norm, but it will serve as a national laboratory to study, understand and innovate the process of conducting clinical trials.
Key components of Trial Innovation Network
The Trial Innovation Network features:
· A single IRB system
· Master contracting agreements
· Quality by design approaches
· A focus on evidence-based strategies to recruitment and patient engagement.
The Trial Innovation Network consists of Trial Innovation Centers (TICs), a Recruitment Innovation Center (RIC), and Hub Liaison Teams.
The TICs are charged with coordinating and providing innovative, high quality operational support for clinical trials (e.g., Data Coordinating Center, central IRB, master contract). There are currently three TICs – Duke/Vanderbilt, University of Utah, and Johns Hopkins/Tufts.
The RIC will provide tools and services to enhance participant recruitment and retention. It is led by Vanderbilt with partners at Columbia, Ohio State, Rockefeller, and the University of Utah.
Northwestern’s role in Trial Innovation Network
Each CTSA, including Northwestern, has created a Hub Liaison Team. The Hub Liaison Team will lead the Trial Innovation Network at the local level and will connect the Hub to the TICs and the RIC. The Trial Innovation Network Hub Liaison Team will use its experience and knowledge of the local environment to coordinate trial innovation activities at its institution, tailoring general network plans into more specific action plans that are best suited for its Hub. The Hub at Northwestern/NUCATS is led by Lewis J. Smith, MD, director of the Center for Clinical Research, and includes members with expertise in the full spectrum of clinical research activities, including regulatory submissions, contracts, participant recruitment and budget preparation, as well as expertise in navigating the local health care system.
As the Trial Innovation Network evolves, updated information will be provided. Additional information is available at https://trialinnovationnetwork.org/. If you are considering developing a multi-center clinical trial for submission to the NIH for funding or if you have questions about how this new resource can help you, please contact the NUCATS Hub Liaison Team at NUTrialInnovationNetwork@northwestern.edu.