COLLABORATIVE CLINICAL RESEARCH CONSORTIUM TO IMPROVE RESUSCITATION OUTCOMES Release Date: September 6, 2001 NOTICE: NOT-HL-02-002 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) Response Due Date: November 30, 2001 PURPOSE The NHLBI is considering establishment of a research consortium to improve clinical resuscitation outcomes from cardiopulmonary and traumatic arrest. In order to determine the most effective and practical program, the NHLBI seeks advice from community resuscitation experts, institutions, and organizations on the barriers to and the design and implementation of such a consortium. BACKGROUND Out-of-hospital deaths due to unexpected cardiopulmonary and traumatic arrest cause premature death and represent a significant public health problem cutting across age, race and gender. No mechanism presently exists to expedite the rapid evaluation and translation of novel promising strategies to improve resuscitation outcomes. A concerted effort is needed to improve outcomes and to decrease the associated morbidity, mortality, and public health burden of traumatic and cardiopulmonary arrest. Such an effort will likely require intensive clinically-related research, including adequately powered randomized trials. Formation of a resuscitation consortium was a major recommendation from the Post-Resuscitation and Initial Utility in Life Saving Efforts (PULSE) workshop, organized as a multi-agency initiative between NHLBI, NICHD, NIGMS, and NINDS of the NIH and FDA and DOD on June 29-30, 2000; summarized in the published Workshop Executive Summary Report (Circulation 2001;103:1182-1184). INFORMATION REQUESTED To aid in the design of possible future research solicitations the NHLBI asks for comments and suggestions on each of the six key areas described below on or before Friday, November 30, 2001. The Institute is interested in determining the most effective infrastructure and organization to conduct clinically-based resuscitation research and trials. For the purpose of this solicitation, resuscitation research is defined as investigations to improve resuscitation outcomes from both trauma and cardiopulmonary arrest. A consortium allows for coordinated efforts and opportunities to optimize the research and clinical strategies and organizational structure, while reducing redundancies associated with several separate research structures. A consortium could include a network of collaborating institutions, such as major medical centers, clinical practice centers, professional organizations, paramedic and community organizations, spread across different geographic areas (rural, urban, international, etc) under a single organizational structure. It is anticipated that the consortium's scientific activities would be centered around designing and conducting phase I-III clinical studies testing resuscitation interventions for cardiopulmonary and traumatic arrest. The NHLBI would like to obtain information regarding the critical elements necessary for and barriers to establishing the consortium. The responses should describe: 1) The organizational structure and overall governance of the Consortium, including what type of institutions or organizations and geographic areas (rural, urban, etc) should be included in the Consortium; 2) How the Consortium would develop, prioritize and implement clinical protocols, including plans for establishing criteria for review and evaluation of potential phase I-III protocols, development and integration of mechanistic sub-studies, and how to set priorities among proposed concepts; 3) Optimal methods for data management from multiple sites; 4) Plans for obtaining consent for conducting clinical resuscitation research, including the challenges in achieving community participation and consent, and obtaining central IRB consent clearance; 5) The anticipated personnel, equipment, and supplies needed for research and administration of such a consortium and estimated range of related costs; and 6) Other critical elements or thoughts not outlined above, including the cost of the research. This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NHLBI. The NHLBI does not intend to award a grant or contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Institute's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Institute shall arise as a result of a response to this request for information or the Institute's use of such information as either part of the NHLBI evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked on a page-by-page basis. All respondents are asked to indicate the type and size of your business or organization, e.g., Large Business, Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other non-profit organization. Responses should be identified with Notice number HL-02-002 and are due by November 30, 2001. Please submit three (3) copies of your response to: Dr. George Sopko Division of Heart and Vascular Disease National Heart Lung and Blood Institute, NIH 6701 Rockledge Drive, Room 9176 Bethesda, MD 20892-7940 (For Fedex or courier, use: Rockville, MD 20892). Telefax and email responses will also be accepted at: 301-480-1336 and SopkoG@nhlbi.nih.gov
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