Transfusion Medicine/Hemostasis Clinical Trials Network-Data Coordinating Center

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DESCRIPTION (provided by applicant) The overall goal of the Transfusion Medicine/Hemostasis Clinical Trials Network (TMH CTN) is to conduct multi-center clinical studies to evaluate treatments and management strategies for children and adults with hemostatic disorders and methods of transfusion support for a variety of patient populations. The New England Research Institutes, Inc. (NERI) will continue to support the TMH CTN as Data Coordinating Center (DCC). The DCC has the following aims: 1) to collaborate in the selection, design, conduct, analysis and reporting of clinical studies and trials; 2) to develop a mechanism for patient recruitment and retention from out-of-network centers; 3) to manage protocol fund disbursement to both core and non-core sites; 4) to develop and maintain a data management system for each network study; 5) to institute quality control procedures including training site study personnel and conducting site visits; 6) to identify central laboratories and central review panels, and develop a system for tracking lab specimens and results; 7) to compile, edit, analyze and report study data; and 8) to coordinate the activities and meetings of the Steering Committee, and provide materials for PRC and DSMB members. During its first four years, the network has begun 3 clinical trials, and has 4 other studies nearing the final stages of development. These ongoing and planned studies include adjudication of specific clinical eligibility criteria and endpoints, a central ultrasound reading facility, and several central laboratories. The Transfusion Medicine/Hemostasis Clinical Trials Network will have an impact on the standard of care by investigating the efficacy, safety, and healthcare policy implications of treatment strategies in transfusion medicine and hematology. Conducting multicenter clinical trials within this network will provide sufficient subjects to evaluate important hypotheses regarding therapy and management in the respective patient populations. Study findings will be disseminated to the medical and scientific communities. The Transfusion Medicine/Hemostasis Clinical Trials Network plans and carries out studies in two areas of medicine. Transfusion Medicine studies investigate which patients need to be treated by giving transfusions, and which types and doses of transfusions to give. Hemostasis studies investigate disorders that put people at increased risk for serious bleeding or blood clots, and how to treat these disorders.