Trial Innovation Network
What is the Trial Innovation Network?
How does it benefit the investigator?
How do consultations work?
How do I submit a proposal?
What is the Trial Innovation Network?
Vision and Mission:
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 will leverage the expertise and resources of the CTSA Program. The Trial Innovation Network will feature 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 investigators are currently building the key elements of the Trial Innovation Network. The goal is to start early projects as soon as possible and collaborate with other NIH Institutes and partners to launch clinical trials in 2017.
The Trial Innovation Network is a new collaborative initiative of the CTSA Program and is composed of three key organizational partners – the Recruitment Innovation Center (RIC), the Trial Innovation Centers (TICs), and the CTSA Program Hubs. *The CCTS is UIC’s Program Hub.
Key elements of the Trial Innovation Network include:
- Trial Innovation Network Central IRB System (uses the SMART IRB Authorization Agreement) – Flexible and efficient IRB review for multicenter studies. Johns Hopkins University, Vanderbilt University Medical Center, and University of Utah serve as the reviewing IRBs for the Trial Innovation Network.
- Standard Agreements System
- Streamlined protocols – TIC and RIC collaboration to develop optimized, streamlined protocols. Will use NIH-FDA Protocol Template.
- Harmonized IT tools and approaches (e.g., tools for recruitment using the electronic health record)
- Systematic approaches to engagement, recruitment, and retention. Data-driven recruitment strategies.
What is the Benefit of using the Trial Innovation Network?
The current state of clinical trials – across the board and in all disciplines – presents many opportunities for improvement. The Trial Innovation Network is designed to be a complementary resource and an option for investigators, NIH Institutes and other stakeholders to optimize clinical trials.
- One-stop shopping to implement clinical studies so investigators can focus on the scientific question
- TICs and RICs – expertise in operational innovation and operational excellence
- CTSA Program hubs – broad expertise; large, diverse patient populations
- More competitive clinical trials applications submitted to NIH ICs
Trial Innovation Network Consultations
Trial Innovation Network Initial Consultations
These consultations are for proposals in the development stage and not yet submitted for funding.
Trial Innovation Network Comprehensive Consultations
Based on the outcome of an Initial Consultation, the next step may be a Comprehensive Consultation. A Comprehensive Consultation cannot be selected by an investigator, but is a decision that is reached after the Initial Consultation and after approval by the Proposal Assessment Team and NCATS.
A Comprehensive Consultation involves mutual agreement and commitment by the investigator and the TIC/RIC to collaboratively develop the proposal into a protocol. In addition, one of the goals in the Comprehensive Consultation process is to obtain input from the CTSA Hubs on the protocol. The estimated number of hours of consultation time for a Comprehensive Consultation has not yet been determined.
After a Comprehensive Consultation, an investigator prepares a clinical trial application for submission to an NIH Institute for funding. The TICs/RIC would serve as the Coordinating Centers for the study and the CTSA Hubs would be potential sites. If an application is funded, the proposed study would be implemented in the Trial Innovation Network using the TICs, RIC, and CTSA Hubs.
Trial Innovation Network Services
If you are requesting a Trial Innovation Network Service, your study should already be funded or you should have already applied for funding. Service requests will be prioritized based on resource availability.
Based on your funding status, investigators are eligible to receive up to TWO of the following services:
- Community Engagement Studio
- Operationalize Standard Agreements
- Operationalize Central IRB
- Recruitment Plan
- Recruitment Feasibility Assessment
- Recruitment Materials
- EHR-Based Cohort Assessment
Trial Innovation Network Proposal Intake Process
Anyone interested in submitting a proposal to the Trial Innovation Network should contact the CCTS’s TIN Liaison, Charity Ball, at email@example.com.
Trial Innovation Network FAQs
Comparison of Oral anticoagulants for extended Venous Thromboembolism (COVET)
The Duke/Vanderbilt Trial Innovation Center (TIC) along with the Vanderbilt Recruitment Innovation Center (RIC) are assisting Dr. Ortel from Duke University on a protocol for the Comparison of Oral anticoagulants for extended Venous Thromboembolism (short title COVET). This study is funded by PCORI and has been supported by the Trial Innovation Network (TIN) since the fall of 2017. The study team is currently preparing for their first site to be activated by the end of July 2018. Interested sites would begin discussions with the study team immediately on next steps to becoming a participating site. To learn more about this project, please see the attached documents below. Interested PIs should contact Charity Ball at firstname.lastname@example.org.
Rhythm Evaluation for AntiCoagulaTion for Atrial Fibrillation (REACT-AF)
The purpose of the Rhythm Evaluation for Anticoagulation with Continuous moniToring of Atrial Fibrillation (REACT-AF) clinical trial is to compare continuous novel oral anticoagulation (NOAC) versus targeted NOAC using an AF-sensitive smartwatch to guide therapy for patients with non-continuous atrial fibrillation (AF). To assess the role of AFSM guidance in the use of NOAC in patients with infrequent AF episodes, the primary endpoints will measure the rate of stroke, arterial embolism, cardiovascular or unknown death, and major bleeding. If proven safe and beneficial, intermittent AFSM-guided NOAC treatment may reduce bleeding events and maintain stroke protection in AF patients compared with continuous NOAC.
REACT-AF is a prospective, unblinded, randomized (1:1 allocation), multi-center, investigational, clinical trial. Subjects randomized to the treatment arm (AFSM-guided NOAC) will take their NOAC for 30 consecutive days if a qualifying AF episode is detected by their device. A qualifying AF episode is defined as continuous AF ≥1 hour in duration. If a subject is already taking a 30-day course of NOAC and experiences a new qualifying AF episode, the NOAC course will be extended for an additional 30 days. Subjects randomized to the control arm (continuous NOAC) will continuously take their NOAC throughout the course of the study. All subjects will be followed for 30 months. Roughly 6,000 subjects will be enrolled in the study to ensure 5,260 randomized subjects.