This application will create a Network Clinical Center (Hub) for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). We propose an integrated, collaborative team of high volume tertiary care medical centers with expertise in emergency care clinical research. The team includes an administrative Hub at Massachusetts General Hospital (MGH) with Spokes across the state including Baystate Medical Center, Beth Israel Deaconess Medical Center, Boston Children's Hospital, Boston Medical Center, Brigham & Women's Hospital, UMass Memorial Medical Center, and St. Vincent Hospital. The Mass-SIREN Group will be managed by a Steering Committee including leaders from each of the member hospitals. It will function administratively as a Hub and Spoke model, but operationally as a collaborative team of medical centers. Our team also includes nationally- and internationally-recognized leaders in neurology, cardiology, pulmonology, hematology, and trauma; we will propose novel ideas for the SIREN network, and innovative solutions to common problems in clinical trials including enrollment and retention.
Specific Aims i nclude:
Aim 1 : To establish an administrative Hub for the SIREN Clinical Trials Network at MGH. This Hub will enroll in each clinical trial. Additionally it will provide administrative coordination across the entire team.
Aim 2. To establish the Mass-SIREN Steering Committee, an integrated leadership team that will coordinate trial management and enrollment across all of our centers.
Aim 3. To provide our existing network of prehospital providers with the regulatory and educational infrastructure to ensure that trained EMS teams can successfully participate in SIREN clinical trials.
Aim 4. To further establish the Mass-SIREN Steering Committee as innovative leaders in emergency care research. We will leverage our individual areas of expertise, our local co-investigators, and our colleagues with subspecialty expertise to design and propose innovative trials for the entire SIREN network. Our academic centers have experience conducting clinical emergency care research, and all have existing pools of trained clinical research coordinators that actively screen in the Emergency Department (ED) to manage enrollment and protocol compliance. Our hospitals see a wide range of patients, including children, underserved minorities, as well as those in urban, suburban, and rural settings. We include all major prehospital providers in Boston and across Massachusetts. Finally, this application highlights our long history of demonstrated interdisciplinary relationships, and that our team has a proven record of joint collaboration, trial performance, and scientific publication. Overall, the MASS-Siren Group includes both the breadth and depth of experience and resources to be an outstanding Network Clinical Center for SIREN.

Public Health Relevance

This application will create a Network Clinical Center (Hub) for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). The Mass-SIREN Group is an integrated, collaborative team of high volume tertiary care medical centers with expertise in emergency care clinical research. This team will enroll patients in trials aimed at improving the care of patients with a range of emergency medical conditions.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24NS100651-02
Application #
9524684
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Mendoza-Puccini, Maria Carolina
Project Start
2017-07-15
Project End
2022-05-31
Budget Start
2018-06-01
Budget End
2019-05-31
Support Year
2
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code