Hematopoietic stem cell (HCT) transplantation offers curative therapy for a variety of malignant and non- malignant disorders. It is limited by donor availability, transplant related toxicity, graft versus host disease, relapse of malignancy, infections, and for some patients, reduction in post-transplant quality of life. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) was established in 2001 to develop and execute scientifically meritorious, prospective clinical trials to address these issues. The Network has launched >20 trials with the support of a Data and Coordinating Center (DCC) comprised of a Consortium of the Center for International Blood and Marrow Transplant Research, the National Marrow Donor Program and The EMMES Corporation. The members of this DCC Consortium propose to continue supporting the Network and managing the efficient development, implementation and completion of high-quality Phase l-lll clinical trials for the Network, including concept evaluation and prioritization, protocol development with appropriate statistical designs, timely activation and accrual, monitoring for safety, compliance and data accuracy, and analyzing and disseminating results. The DCC Consortium will coordinate and support all BMT CTN activities maintaining a state-of-the-art database and systems for acquisition and storage of biologic specimens, ensuring data quality, laboratory compliance and adherence to regulatory requirements, managing contractual arrangements and fiscal activities, monitoring and improving center and overall Network performance and supporting all Network committees and activities with meeting planning and other logistical support. The Consortium will also help amplify and leverage Network resources through collaboration with other scientific bodies including National Cancer Institute-funded Cancer Cooperative Groups and the Stem Cell Therapeutic Outcomes Database to maximize successful completion of high quality and high priority clinical trials in HCT.
The proposed Data and Coordinating Center (DCC) will support all activities of the BMT CTN, using the extensive expertise of the investigators in clinical research and transplantation. We will take advantage of collaborations with other organizations and initiatives to maximize efficiency and trial participation. The goal is to complete high quality clinical trials that focus on the most importan barriers to transplant success. Public Health Relevance: There is an urgent need for interventions that increase patient comprehension related to the informed consent process for participation in hematopoietic cell transplantation (HCT) clinical trials. We will use the platform of a large cooperative group. Blood and Marrow Transplant Clinical Trials Network, to study a novel easy-to-read informed consent (ETRIC) form. If effective and acceptable, it will meet an important unmet need to enhance patient understanding of HCT clinical trials
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