Transfusion Medicine/Hemostasis Clinical Research Network

描述（由申请人提供） 本申请是对标题为“关于继续开展输血医学/止血临床试验网络（TMH CTH）有限竞争的公告”（U 01）的RFA-HL-06-108的回应。输血医学和止血的临床问题往往涉及大量相对罕见的疾病。由于任何特定机构都缺乏关键数量的患者，因此很难回答有关输血医学/止血特定领域的临床问题。TMH网络成立于2002年，由17个核心中心组成，被认为是该医学领域的领导者。这是一个国家资源分配的目的是提高知识和理解领域的输血医学和止血。该网络促进了对患有止血疾病的儿童和成人的潜在益处的新型管理策略的比较，并评估了用于治疗血液病的新型和现有血液疗法和细胞因子。过去4年的重点是确定需要科学探索的输血医学/止血领域，制定研究方案，以促进最佳治疗为目标，启动临床试验，并走向完成和数据分析。治疗性试验涉及使用研究药物或血液制品，包括那些已经批准和使用的，以及那些目前尚未使用。该网络强调输血医学和血液学专家之间密切合作的优势，以探索其他血液衍生产品（如粒细胞）的作用。三项研究已获得方案审查委员会和DSMB（PLADO、SHIP和RICH）的批准，目前正在参与中心进行或即将启动临床试验。该网络还有其他几项即将启动的研究（HIT、粒细胞研究、CVAD、星星）。每年，成千上万的患者接受治疗的疾病，如“FTP和血友病。还有数百万人患有血小板减少症、中性粒细胞减少症和贫血。该网络为未来的研究奠定了基础，以帮助治疗和解决这些问题。

DESCRIPTION (provided by applicant) This application responds to RFA-HL-06-108 entitled "Announcement of a Limited Competition for the Continuation of the Transfusion Medicine/Hemostasis Clinical Trials Network" (TMH CTH) (U01). Clinical issues in transfusion medicine and hemostasis often deal with a large number of relatively uncommon diseases. It has been difficult to answer clinical questions about specific areas of transfusion medicine/hemostasis due to the lack of a critical number of patients at any given institution. The TMH Network was established in 2002, composed of 17 core centers recognized as being leaders in this field of medicine. It is a national resource assigned with the purpose of advancing knowledge and understanding in the area of transfusion medicine and hemostasis. The Network has promoted the comparison of novel management strategies of potential benefit for children and adults with hemostatic disorders and has evaluated novel as well as existing blood therapies and cytokines for the treatment of hematologic disorders. The emphasis over the last 4 years has been on identifying areas of transfusion medicine/hemostasis that need to be scientifically explored, developing research protocols with a goal toward facilitating optimal therapy, initiating clinical trials, and moving towards completion and data analysis. Therapeutic trials have involved the use of investigational drugs or blood products, including those already approved and used, as well as those not currently used. The Network emphasizes the strength of the close collaboration between experts in transfusion medicine and hematology to potentially explore the role for other blood derived products, such as granulocytes. Three research studies have been approved by the Protocol Review Committee and DSMB (PLADO, SHIP and RICH) and are currently being conducted at participating centers or are on the verge of initiating clinical trials. The Network has a pipeline of several other studies that are close to being activated (HIT, Granulocyte Study, CVAD, STAR). Each year, thousands of patients receive treatment for diseases like "FTP and Hemophilia. Many millions more have problems with thrombocytopenia, neutropenia and anemia. This network has established a building block for future research to help treat and combat these problems.