The Trial Innovation Network is a new collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC).
The vision for the Trial Innovation Network is to innovatively address critical roadblocks in clinical research 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 will leverage the expertise and resources of the CTSA Program. The Trial Innovation Network features a single IRB system, master contracting agreements, quality by design approaches, and a focus on evidence-based strategies to recruitment and patient engagement.
The goal of the Trial Innovation Network is to not only execute trials better, faster, and more cost-efficiently but, importantly, to be a national laboratory to study, understand and innovate the process of conducting clinical trials.
The CTSA Program Hubs and other clinical research institutions are the frontline of the Trial Innovation Network. The UCLA CTSA Program Hub team uses their experience and knowledge of the local environment to facilitate collaboration with the Trial Innovation Network in developing and disseminating clinical trial innovations and excellence.
*Point of Contact*
LIAISON TEAM STAFF
A community engagement studio is a structured method of engagement that allows meaningful involvement of diverse groups of stakeholders. Engagement studios can be used to facilitate project-specific input including providing guidance and recommendations on how to develop or refine recruitment materials and messages.
Key features of this Trial Innovation Network Service include:
The complexity of contract negotiations can be a major barrier to timely study start-up. With this service, we will provide recommendations on how to use the FDP-CTSA agreement. This Standard Agreement can potentially be used by each of the participating institutions in your multi-site study.
**For studies pending funding or prepared to submit for funding (get up to 2 services)
Recent policy changes by the NIH and DHHS require the use of a single IRB of record for multi-site research to reduce redundant IRB review and to streamline investigator submission processes. The Trial Innovation Network has established three Central IRBs (CIRBs), which are based on the SMART IRB Authorization Agreement. This service will provide CIRB services to a funded multi-center clinical trial.
For each study, the Trial Innovation Network CIRB will also provide resources, tools, and a web-based platform (SMART IRB Exchange) to operationalize the CIRB. The goal is to ensure all site investigators understand the process for initiating the use of a CIRB at their local institution, as well how to submit and report to the CIRB from initial submission to study closeout.
The Trial Innovation Network will help consider ways that Electronic Health Record (EHR) data may be leveraged to inform study design and potential site selection. You can expect expert clinical and technical review of a study’s goal recruitment population and high level assessment of computable phenotyping. Funded projects may also request and receive support required to organize distribution of phenotype algorithms to potential CTSA hubs and collation of results
E2E Consultations will take a protocol-specific approach to the prospective selection of suitable efficacy and effectiveness endpoints, advice on the statistical analysis plan, and advice on the role of the DSMB in transitioning from the efficacy to the effectiveness phase.***
***For studies not ready for submission for funding (get 1 service)
Collaboration Webinars: Hear from CTSA Program experts on various trial-related topics to improve your project.
Open Forums: Hear from Network Project Leads on various Network topics and have an opportunity to ask questions and receive information. These standing sessions will be held once a month and will generally be 60 minutes in length. The forums will be informal with introductory slides leading into an open dialogue session.