U24TR004440
Cooperative Agreement
Overview
Grant Description
Johns Hopkins University Trial Innovation Center - The Johns Hopkins University (JHU) Trial Innovation Center (TIC) is a well-established, highly functioning team with a goal of dramatically improving the conduct, efficiency, and impact of multisite randomized controlled trials.
The TIC includes experienced trial scientists, project managers, statisticians, and trial staff with external collaborators from 5 research intensive CTSA hubs. BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute Version 2.0 of the Trial Innovation Network (TIN) program and its specific tasks as previously and collaboratively determined by the TICs, RICs, and NCATS.
During TIN 1.0, our joint expertise developed and demonstrated new methods for multicenter trials and provided these methods via the TIN platform to individual CTSA hub PIs wishing to perform multisite randomized trials. This proposal is derived from our established track record of trial execution accomplishments and trial science innovations, which will facilitate dissemination of these methods and specific trial tools towards the NCATS goal to speed translational research.
We identified needs not met in TIN 1.0 including: trial training of hub staff, training in operations rather than strategy, preceptorship for hub CCC/DCC capabilities, and need for up-to-date operational methods/tools. In TIN 2.0, we will further develop new trial tools and methods for testing their ease of implementation at CTSA hubs, demonstrate the effectiveness of this approach, and disseminate broadly to CTSA hubs, by using case studies and didactics.
We propose an integrated, coordinated, multi-stakeholder TIC process to improve the efficiency and quality of multi-site trial initiation and subsequent execution by CTSA sites. Our group of external collaborators will work as a sample of the larger CTSA-TIN consortium to develop hub implementation and dissemination approaches on both a case- and consortium-wide basis.
The JHU TIC will leverage operational activities in CTSA trials implementation to study novel operational innovations that improve participant engagement, intervention adherence, and measurement of trial endpoints. We will measure benefits using explicit efficiency- and quality-focused metrics to test these innovations.
The scientific purpose of our team’s efforts will be to demonstrate that TIC innovations in trial design, execution, and evaluation can lead to better trial performance, including faster start-up, faster completion, greater protocol compliance, and more precise endpoints. We will disseminate results of validated CTSA-TIN innovations produced from consortia trials to CTSA hub clinical trial teams and research trainees.
We will collaborate with NCATS to utilize the platform demonstrated in TIN 1.0 to engage and equip a multisite randomized clinical trial workforce through the CTSA hubs to perform trials faster and at a higher quality in TIN 2.0.
The TIC includes experienced trial scientists, project managers, statisticians, and trial staff with external collaborators from 5 research intensive CTSA hubs. BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute Version 2.0 of the Trial Innovation Network (TIN) program and its specific tasks as previously and collaboratively determined by the TICs, RICs, and NCATS.
During TIN 1.0, our joint expertise developed and demonstrated new methods for multicenter trials and provided these methods via the TIN platform to individual CTSA hub PIs wishing to perform multisite randomized trials. This proposal is derived from our established track record of trial execution accomplishments and trial science innovations, which will facilitate dissemination of these methods and specific trial tools towards the NCATS goal to speed translational research.
We identified needs not met in TIN 1.0 including: trial training of hub staff, training in operations rather than strategy, preceptorship for hub CCC/DCC capabilities, and need for up-to-date operational methods/tools. In TIN 2.0, we will further develop new trial tools and methods for testing their ease of implementation at CTSA hubs, demonstrate the effectiveness of this approach, and disseminate broadly to CTSA hubs, by using case studies and didactics.
We propose an integrated, coordinated, multi-stakeholder TIC process to improve the efficiency and quality of multi-site trial initiation and subsequent execution by CTSA sites. Our group of external collaborators will work as a sample of the larger CTSA-TIN consortium to develop hub implementation and dissemination approaches on both a case- and consortium-wide basis.
The JHU TIC will leverage operational activities in CTSA trials implementation to study novel operational innovations that improve participant engagement, intervention adherence, and measurement of trial endpoints. We will measure benefits using explicit efficiency- and quality-focused metrics to test these innovations.
The scientific purpose of our team’s efforts will be to demonstrate that TIC innovations in trial design, execution, and evaluation can lead to better trial performance, including faster start-up, faster completion, greater protocol compliance, and more precise endpoints. We will disseminate results of validated CTSA-TIN innovations produced from consortia trials to CTSA hub clinical trial teams and research trainees.
We will collaborate with NCATS to utilize the platform demonstrated in TIN 1.0 to engage and equip a multisite randomized clinical trial workforce through the CTSA hubs to perform trials faster and at a higher quality in TIN 2.0.
Awardee
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Funding Agency
Place of Performance
Baltimore,
Maryland
212051832
United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 197% from $4,972,809 to $14,762,337.
The Johns Hopkins University was awarded
JHU Trial Innovation Center: Improving Multisite Trials
Cooperative Agreement U24TR004440
worth $14,762,337
from National Institute on Aging in July 2023 with work to be completed primarily in Baltimore Maryland United States.
The grant
has a duration of 4 years 9 months and
was awarded through assistance program 93.866 Aging Research.
The Cooperative Agreement was awarded through grant opportunity Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional).
Status
(Ongoing)
Last Modified 9/5/25
Period of Performance
7/5/23
Start Date
4/30/28
End Date
Funding Split
$14.8M
Federal Obligation
$0.0
Non-Federal Obligation
$14.8M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for U24TR004440
Transaction History
Modifications to U24TR004440
Additional Detail
Award ID FAIN
U24TR004440
SAI Number
U24TR004440-4194161040
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NR00 NIH National Center for Advancing Translational Sciences
Funding Office
75NN00 NIH National Insitute on Aging
Awardee UEI
FTMTDMBR29C7
Awardee CAGE
5L406
Performance District
MD-07
Senators
Benjamin Cardin
Chris Van Hollen
Chris Van Hollen
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Center for Advancing Translational Sciences, National Institutes of Health, Health and Human Services (075-0875) | Health research and training | Grants, subsidies, and contributions (41.0) | $3,415,984 | 69% |
| National Institute on Aging, National Institutes of Health, Health and Human Services (075-0843) | Health research and training | Grants, subsidies, and contributions (41.0) | $1,556,825 | 31% |
Modified: 9/5/25