Trial Innovation Unit (TIU)

The Trial Innovation Unit (TIU) is a service jointly powered by the ICTR and BIOS

Clinical trials are tough and we want to support you to ensure that your trial is successful. Submit a TIU intake form to get connected with us. There is no charge for the initial consult.

What Can Working With the TIU Do for You?

We will support you in trial design, strategic operational planning, and leveraging all the resources of the ICTR. We work with trials funded by the NIH, commercial sponsors, or foundations.

The TIU is committed to facilitating the development of investigative expertise. K-grant, T-grant, and other early career investigators are invited to participate in project evaluation, trial simulation, and planning activities. Biostatistical doctoral and postdoctoral candidates may participate in statistical analysis plan development and reporting.

The TIU provides expert consultative support to investigators with small, local multi-center translational studies needing to:

    • Improve research study design, trial operations, and analysis plans.
    • Explore opportunities for single and multi-center trial innovation.
    • Improve diversity and community engagement in clinical trials.
    • Assess translational pathway and readiness for multi-center trials.
    • Provide strategic assistance with grant applications.
    • Develop and improve the overall stewardship, efficiency, accountability, and transparency of clinical trials.

The Trial Innovation Unit (TIU) is composed of two key organizational partners—the ICTR and BIOS, a JHU-based academic research organization. A collaborative initiative, the TIU leverages the expertise, skills, and knowledge of ICTR and BIOS faculty to ensure the best possible outcomes for the trials we support. The TIU supports innovation in clinical trials and studies while providing meaningful scientific review to ensure rigorous, informative research.

Watch this recording of a TIU presentation (password: ICTR-3182021) fom ICTR’s Third Thursday series to learn more.

 

The TIU Process Flow

The easy 4-step process shown below supports investigators in their trial needs.

The TIU consultative process provides study teams with referrals to experts in their fields and may connect investigators to services which may include any or all of the following components:

    • Cohort discovery via PCORNet and TriNetX mechanisms
    • Site selection and readiness assessment within and beyond the Johns Hopkins Clinical Research Network
    • Single IRB (sIRB) review in collaboration with the regulatory knowledge and support core
    • Review method development to track study performance and outcomes at the local hub and affiliated sites
    • Organization and trial execution strategy consultation
    • Direction and strategy for grant preparation

TIU Associated Costs

The TIU consultative process is free to you and funded by the current CTSA grant from the National Center for Advancing Translational Sciences (NCATS). 

The TIU representative will organize an initial meeting of 1 hour for the investigator with experts from the ICTR and BIOS.

After the initial meeting, the TIU service provides an additional hour of free support for the research project to provide supporting material and/or further planning discussed during the initial meeting. The initial TIU 2 hour consult is free. If you need specific grant services, planning or additional support after the 2 hour consult, a broad spectrum of services are available through the TIU teams for a fee.

TIU Leadership and Administrative Team Members

Here are some of the people that can help you navigate the entire grant process. Our TIU leadership are experts in:

    • Multi-center clinical trials
    • Trial start-up, enrollment, data quality, GCP, IRB and sIRB processes, contracting, human subjects research
    • Leadership and management of research teams
    • Use of performance metrics
    • Comprehensive safety & risk management
    • Local research conduct

DANIEL FORD, MD, MPH
Director, PI, ICTR
Vice Dean for Clinical Investigation, School of Medicine

DAN HANLEY, MD
Deputy Director, ICTR
Division Director, BIOS, School of Medicine

KAREN BANDEEN ROCHE, PHD
Director of Biostatistics, Epidemiology and Research Design (BERD), ICTR
Program Director, Biostatistics Center 

CHARLES FLEXNER, MD
Chief Scientific Officer for Strategy and Integration

NICHOL MCBEE, MPH
Research Associate, Department of Neurology
Division Manager, BIOS
Administrator, TIU

LIZ MARTINEZ, RN, BSN, CCRC
Research Participant Advocate
Senior Clinical/Research Liaison, ICTR

MEGHAN HILDRETH, MS
Senior Research Program Coordinator, BIOS
Senior Research Program Coordinator, TIU

ANGELINE NANNI, MBA, MS
Research Navigator, BIOS
Research Navigator, TIU