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Researcher Resources

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TRIAL INNOVATION NETWORK AT UCLA CTSI

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 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 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.


PRINCIPAL INVESTIGATOR
Steven Dubinett 

MEDICAL DIRECTOR
Arash Naeim 


ADMINISTRATOR/PROJECT MANAGER
Stephanie Tarroza
*Point of Contact*
starroza@mednet.ucla.edu

LIAISON TEAM STAFF

Terra Hughes
Liaison Team Member
Director, Office of Regulatory Affairs, CTSI
tnhughes@mednet.ucla.edu

Maggie Lindenbaum
Liaison Team Member 

Alice Young-Singleton 
FDP-CTSA Standard Agreements Contact

Community Engagement Studios*

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:

  • Assessing whether a studio might be appropriate based on the needs of a study and if so, where a studio has the potential to be most valuable
  • Identifying community and/or patient stakeholders for studio
  • Convening community engagement studio
  • Summarizing recommendations on how to develop and refine recruitment plan, study messaging and materials
*For studies that are funded (get up to 2 services)

Operationalize Standard Agreements* **

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 that are funded (get up to 2 services)

**For studies pending funding or prepared to submit for funding (get up to 2 services)

Operationalize Central IRB* **

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. 

*For studies that are funded (get up to 2 services)
**For studies pending funding or prepared to submit for funding (get up to 2 services)

Recruitment Plan

An effective recruitment plan includes strategies to identify and engage specific population(s) of relevance for a trial including how to communicate and market a study in order to engage potential participants and meet realistic enrollment and retention goals. The recruitment plan service includes providing advice and recommendations on recruitment strategies.* **

*For studies that are funded (get up to 2 services)
**For studies pending funding or prepared to submit for funding (get up to 2 services)

Recruitment Feasibility Assessment

Recruitment feasibility assessment is the process of evaluating the possibility of recruiting an adequate number of participants with the appropriate range of characteristics (such as age, gender, race/ethnicity, and health status) to meet enrollment goals on the projected timelines and cost. The recruitment feasibility assessment considers environmental (such as location, competition, prior success recruiting, potential participant pool) strengths and weakness as well as logistical, motivational and behavioral barriers to recruitment and retention.* ** ***

*For studies that are funded (get up to 2 services)
**For studies pending funding or prepared to submit for funding (get up to 2 services)
***For studies not ready for submission for funding (get 1 service) 

Recruitment Materials

Recruitment materials may include any written or verbal communication delivered through a range of multimedia channels and platforms to increase enrollment.* **

*For studies that are funded (get up to 2 services)
**For studies pending funding or prepared to submit for funding (get up to 2 services)

EHR-based Cohort Assessment* **

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 

*For studies that are funded (get up to 2 services)
**For studies pending funding or prepared to submit for funding (get up to 2 services)

Initial Consultations

Initial consults are available and can be arranged with CTSA Program Hub Project Manager, Stephanie Tarroza.***

***For studies not ready for submission for funding (get 1 service)

E2E Consultations: Efficacy to Effectiveness Trial Design

Efficacy to Effectiveness (E2E) is an approach to clinical trial design that addresses the effectiveness and safety gaps that often occur in standard randomized controlled trials. E2E Trials are designed prospectively, whereby an effectiveness trial would commence seamlessly upon completion of the efficacy trial. This approach offers an opportunity for improved understanding of how a treatment will work in more usual real-world clinical settings. 

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) 

Network Events

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.