Trial Innovation Network (TIN)

TIN helps investigators consider ways that Electronic Health Record (EHR) data may be leveraged to inform study design and potential site selection. Services include 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.

Initial Consultations

Initial consults are available and can be arranged with with UCLA CTSI TIN Liaison, Jordan Daniel. The TIN Liaison can help you navigate all the potential UCLA CTSI and TIN services that may be available to you for your multi-site clinical study, whether it is funded or proposed.

E2E Consultations

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 may include:

• Working with an investigator to design a study that includes both efficacy and effectiveness endpoints
• Providing advice on suitable populations to include in the effectiveness phase of the trial
• Creating a statistical analysis plan
• Identifying the role of the Data Safety Monitoring Board in moving from the efficacy to the effectiveness phase

These consultative studios allow for divers groups of stakeholders to be involved in the planning and implementation of research. Studios can facilitate guidance on identifying and addressing barriers to participation and how to develop or refine recruitment materials and messages. 

Key features of this TIN service may 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
• Advice on when and how to conduct studios

TIN offers a number of Network Events open to the general public.

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. 

Recruitment and Retention Planning

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.

Key features include:

• Comprehensive review of your study and existing recruitment plan
• Identification of stakeholders and recruitment partners (such as providers and community organizations) as well as recruitment locations
• Guidance on understanding unique needs and preferences of potential participants as well as barriers and facilitators to recruitment and retention
• Tailored recommendations for engaging participants from your study population

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.

Key features include:

• Comprehensive review of your study and budget
• Assessment of the likelihood your study will meet predefined recruitment and retention goals
• Tailored advice on how to enhance feasibility 

Recruitment Materials

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

Key features include:

• Review of materials needs, including dissemination plans
• Recommendations and templates that might improve the recruitment of potential participants for specific studies

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. TIN has established three Central IRBs (CIRBs), which are based on the SMART IRB Authorization Agreement. TIN can provide support, resources, tools, and a web-based platform (IREx) to ensure all site investigators understand how to use a sIRB at their institution, from initial submission to study closeout.

Working with your local UCLA CTSI TIN Liaison, TIN can provide you:

• Support, resources, and tools, for creating a Single IRB Plan
• A web-based platform (IREx) to track site progress towards initial approval, documenting reliance arrangements, capturing study-specific local considerations and storing, disseminating sites’ IRB approvals; and facilitating communications
• Introductory training ensuring all site investigators understand how to use a sIRB at their institution
• Support developing a study team communication plan
• Informed consent form templates

Contact the UCLA CTSI TIN Liaison today to get started. 

The complexity of contract negotiations can be a major barrier to timely study start-up. With this service, TIN provides 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, especially if you submit your proposal prior to contract initiation.