The Blood and Marrow Transplant Clinical Trials Network - Data Coordinating Center (U24 Clinical Trial Not Allowed)

Background
The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is a collaborative multi-site clinical program sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI) since 2001. The network aims to promote the efficient comparison of novel treatment approaches and management strategies for the potential benefit of children and adults undergoing hematopoietic stem cell transplantation (HCT), either alone or in combination with novel cell-based therapies. The overall goals are to identify and address gaps in HCT and adoptive cell therapy outcomes for blood diseases, rapidly disseminate study results to improve the scientific basis of the therapies being studied, provide a platform to train emerging clinical trial investigators, build a biorepository for future research that includes specimens linked to clinical data and outcomes from patients with non-malignant blood diseases who receive these therapies, and ultimately improve the life and quality of life for patients with blood diseases who receive HCT or adoptive cell therapies.

Grant Details
The recipient of this Notice of Funding Opportunity (NOFO) will provide the relevant medical, scientific and regulatory expertise, as well as support for coordination, data management, budgetary management, statistical design and analysis, and operational support for the program.

The Data Coordinating Center (DCC) is responsible for overall coordination and administration of the BMT CTN program; maintaining the Manual of Operating Procedures; supporting protocol development, finalization and prioritization; providing sample size calculations, sophisticated statistical advice, and data analyses; developing accrual plans and patient-facing materials; facilitating safety monitoring of BMT CTN trials; providing regulatory support, secure data management systems and systems for quality control; preparing minutes and reports for BMT CTN committees/subcommittees.

Identifying, qualifying and subcontracting with Affiliate transplant centers (Affiliate Centers) and other collaborators for BMT CTN clinical trials; reimbursing participating centers on a per-patient basis; subcontracting central laboratories needed for network studies including long-term storage, retrieval, and shipment of biospecimens.

Preparing data and safety reports for the Data Safety and Monitoring Boards (DSMBs); coordinating the development of manuscripts and presentations; coordinating meetings and activities of the DSMBs, the BMT CTN Steering Committee, the External Advisory Committee, and other BMT CTN committees.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status or without 501(c)(3) IRS status, for-profit organizations (including small businesses), state governments, county governments, city or township governments, special district governments, Indian/Native American Tribal Governments (Federally Recognized), U.S. Territory or Possession entities. Foreign institutions are not eligible to apply. The applicant organization must have an active registration in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code if foreign organization applying through a U.S. entity in SAM.gov., Unique Entity Identifier (UEI), eRA Commons account. Program Directors/Principal Investigators must have an eRA Commons account.

Period of Performance
The project period is 7 years beginning in Fiscal Year 2024.

Grant Value
The NHLBI and NCI intend to commit total costs up to $51,860,000 to fund one award to support a 7-year project beginning in Fiscal Year 2024. Application budgets may request direct costs of up to $4,338,710 in FY 2024.