The JHU-Tufts Trial Innovation Center (TIC) is an established, functioning team of multisite trial PIs, experienced lead managers, administrators, and scientists at both Johns Hopkins University (JHU) and Tufts University (including its longstanding partners, the Harvard Clinical Research Institute (HCRI) and Massachusetts Institute of Technology (MIT)). BIOS, a JHU trials research group, will operationally convene this group and provide staff to execute the required TIC program and its specific tasks. Our joint expertise developing new methods for multicenter trials will be provided to the TIC program whereby individual TIC trials will be executed with excellence and innovations incorporated into subsequent trials. This proposal is derived from our established track record of neuroscience and Alzheimer?s disease and other dementia trial execution accomplishments and innovations, which will facilitate progress towards the NCATS goal of producing three robust TICs to speed translational research. We will Develop, Demonstrate, and Disseminate an integrated, coordinated, multistakeholder TIC process to improve the efficiency and quality of multi-site trial initiation and subsequent execution by sites. The JHU-Tufts TIC will leverage operational service expertise in geriatrics, diseases of aging and Alzheimer?s disease for CTSA trials implementation to study novel operational innovations. The scientific purpose of our team?s efforts will be to demonstrate that TIC innovations in trial design, execution, and evaluation will lead to better trial performance, including faster start-up, faster completion, and greater protocol compliance for all NCATS program trials and be applicable to Alzheimer?s disease, biomarker studies (amyloid A?, tau, cortical thickness) and other aging trials. We will measure benefits using explicit efficiency and quality-focused metrics to test these innovations. We will disseminate results of valid CTSA-TIC innovations produced from all consortia trials to current clinical trial teams and research trainees. We hope to collaborate with NCATS to produce a platform that allows investigators to perform trials faster and at a higher quality.

Public Health Relevance

Johns Hopkins University (JHU) and Tufts University (with Harvard Clinical Research Institute and Massachusetts Institute of Technology) have formed a working group to improve the science of randomized clinical trials. BIOS, a JHU trials research group, will convene this group of randomized, controlled trial experts to develop a Trial Innovation Center (TIC) as part of a bigger NCATS research resources initiative. The scientific purpose will be to demonstrate that innovations in trial design, execution, and evaluation will advance NCATS' goal of getting more treatments, to more patients, more quickly.

National Institute of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Resource-Related Research Projects--Cooperative Agreements (U24)
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Special Emphasis Panel (ZTR1)
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Atkinson, Jane C
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Johns Hopkins University
Internal Medicine/Medicine
Schools of Medicine
United States
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Baker, Alexandra Delaney; Rivera Perla, Krissia Margarita; Yu, Zhiyuan et al. (2018) Fibrinolytic for treatment of intraventricular hemorrhage: A meta-analysis and systematic review. Int J Stroke 13:11-23