This funding opportunity announcement is to solicit applications for neurological clinical trials to be carried out in the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). SIREN provides a robust and readily accessible infrastructure for the implementation of clinical trials in a breadth of emergency indications related to neurology such as status epilepticus, traumatic brain or spinal cord injury and headache. The network will also undertake studies related to the mission of the National Heart, Lung and Blood Institute. Investigators who will submit a SIREN trial through the NHLBI should not use this FOA. Instead they should use the NHLBI PAR 16-300 Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3) FOA, and the NHLBI PAR 16-301, Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (U24), or their reissue.
SIREN consists of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC) and 11 clinical centers with their satellite sites (Hub and Spoke clinical site model). The SIREN infrastructure can accommodate at least four simultaneous large (>1,000 patient), simple, pragmatic trials in the Emergency Department (ED) and pre-hospital (e.g., transportation, EMS) settings.
Scope of the Program
NINDS, NHLBI and NCATS have established the SIREN network to facilitate the execution of clinical trials in neurological and cardiovascular emergencies. It is expected that all multi-center clinical trials supported by NINDS and NHLBI in these areas will be considered for implementation through SIREN.
This FOA encourages and provides a mechanism for the submission of applications that will use the SIREN network for multi-center clinical studies in the area of neurologic emergencies. Simple, pragmatic clinical trials are of special interest. Typical features include brief, inclusive patient eligibility criteria, procedures which integrate easily into or with standard of care practices and limited, focused data collection. Other trials may test novel devices, medications or procedures or may compare effectiveness of existing therapeutic approaches. Trials in SIRENmust be hypothesis driven. Registries or descriptive observational studies will not be supported.
It is the intention of NHLBI and NINDS that SIREN will maintain a balanced portfolio of studies in each of these two areas, defined as follows:
Neurological emergencies (excluding stroke) – studies of agents, devices, or strategies to treat conditions in the pre-hospital setting or the emergency department, such as (but not limited to) seizures, migraine headaches, traumatic brain injury, anoxic brain injury, spinal cord injury and meningitis. Stroke trials should be directed to the NINDS supported StrokeNet.
Heart, lung and blood emergencies– studies of agents, devices, or strategies to treat conditions in the pre-hospital setting or the emergency department, such as (but not limited to) cardiac arrest, chest pain, myocardial ischemia and infarction, and cardiac arrhythmias. Other emergency conditions affecting the lungs and blood are also of interest, including asthma, pulmonary embolism and the use of blood products in traumatic injury. Investigators who will submit a SIREN trial through the NHLBI should not use this FOA. Instead they should use the NHLBI PAR 16-300 Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3) FOA, and the NHLBI PAR 16-301, Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (U24), or their reissue.
Applications for exploratory studies (for example, early dose ranging studies with biomarker outcome, early proof of mechanism or proof of concept trials) are not supported by this FOA. Late Phase II trials are within the scope of this FOA. Clinical trials are conducted to provide a definitive answer regarding the safety and efficacy of an intervention or to compare the effectiveness of two or more interventions. The use of innovative and efficient trial designs is encouraged, such as adaptive dose-finding designs and designs incorporating plans for sample size recalculation. The proposed research must address a scientifically important question, provide valuable information to the existing knowledge base, and have public health relevance. The trial design should ensure that high quality, complete data regarding the primary outcome will be collected in the most efficient manner in terms of time, resources, and burden to subjects. Secondary outcomes should be included only when they are anticipated to provide important supportive or explanatory data. The necessity of each secondary endpoint must be justified in light of cost and burden.
The priority of proposed network trials deemed by peer review to be highly meritorious will be based on factors including infrastructure capacity and availability of patient populations considering current ongoing trials within the network. The timing of funding and initiation of the trial will be determined by the NHLBI and NINDS with input from the SIREN leadership as necessary. This will insure that studies can be conducted within the proposed timeline included in the research plan of the application.
Applications will be expected to use the SIREN clinical sites, the CCC to manage the clinical operations and the DCC to manage data collection, compliance and analysis.
Applications are encouraged from investigators whose institutions are not part of the funded SIREN network.
Deadlines: Standard dates apply
Filed Under: Funding Opportunities