Out-of-hospital cardiopulmonary arrest (OOH-CA) and life-threatening traumatic injury (LTI), including traumatic brain injury, have been jointly investigated since they share several common features. The Clinical Trial Center (CTC) for a Resuscitation Research Consortium has played a central role in conducting clinical trials in the areas of OOH-CA and LTI. With the goal of improving resuscitation outcomes, the CTC has the following aims: 1) To provide administrative and statistical leadership for clinical trials in OOHCA an d LTI including all phases of currently conducted trials. 2) To continue our observational study of care processes and outcomes for emergency medical services (EMS) care through the Epistry registry. 3) To rapidly design, and implement a series of high-quality Phase II and Phase III randomized trials that have high internal and external validity. 4) To maintain and improve an efficient and secure information technology system for collection, processing, storage, and quality control of the data. 5) To take the lead and/or collaborate regarding timely dissemination of knowledge within the consortium, with sponsors, oversight bodies, and the scientific community, thereby improving resuscitation outcomes. 6) To provide methodological leadership for clinical trials in OOH-CA and LTI. The CTC will draw upon its extensive experience with community emergency service providers, emergency physicians and cardiologists to actively collaborate with highly-qualified clinicians working in OOH-CA or LTI research at each regional clinical center (RCC). The Center has and will continue to make substantial contributions to all aspects of clinical trial design, implementation and conduct based on its statistical, administrative and medical expertise. The Data Coordinating Center will enhance an existing interactive information technology system to facilitate communication and development. Robust, secure and confidential methods of data management and quality control will be used to provide a central repository for timely acquisition of data, so that prompt careful analyses can be conducted. Multiple strategies will be used to ensure timely and effective dissemination of study results to policy makers, practitioners, and the public in order to improve EMS-related health care delivery in the United States and Canada. The Resuscitation Outcomes Consortium (ROC) will provide administrative leadership for clinical trials in the area of out-of-hospital cardiopulmonary arrest and life-threatening traumatic injury. The Consortium is a group of 9 regional clinical centers within the United States and Canada. (End of Abstract) Resume: In this excellent application the data coordinating center proposes to provide administrative leadership, maintain and use observational data in the Epistry, design and implement clinical trials, maintain and improve an efficient and secure information technology, and lead in knowledge dissemination for the resuscitation outcomes consortium (ROC). The strengths of this application were its potential impact on out-of-hospital cardiopulmonary arrest and life-threatening traumatic injury, the DCC's infrastructure, the statistical expertise and the excellent data collection and management. There were several concerns that lowered enthusiasm. These included: 1) A lack of randomized data, 2) No discussion of major challenges and how the DCC overcame them and 3) The lack of a Co-PI and leadership plan. In addition, reviewers felt that protocol training and certification should be done by DCC and not by individual sites. Also, there was much discussion about missing data and the conclusion that a way was needed to locate missing demographic data. These and other issues lowered the final impact score. Overall, the DCC was found to have contributed significantly to ROC.
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