NOT-HL-23-069: Notice of Intent to Publish a Funding Opportunity Announcement for The Blood and Marrow Transplant Clinical Trials Network - Data Coordinating Center (U24)
National Heart, Lung, and Blood Institute (NHLBI)
The National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI) intend to publish a Request for Applications (RFA) seeking applications from qualified institutions or consortia willing to participate with NHLBI in the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) as a Core Clinical Center or Core Clinical Consortium (CCCs). The CCCs will be expected to support and conduct multi-center collaborative clinical research evaluating hematopoietic cell transplantation (HCT) and adoptive cell therapies to improve the health and quality of life for children and adults with life-threatening non-malignant and malignant blood diseases. Collaboration among the CCCs, the Data Coordinating Center (DCC), participating Affiliate clinical sites, and other stakeholders is expected. As in the past, BMT CTN will collaborate on trials led by the NCI Clinical Trials Network. BMT CTN will also engage Affiliate sites to allow a wider range of investigators from broader geographic areas to participate in trials. Additionally, NHLBI and NCI plan to issue a companion RFA for the DCC to provide coordination, infrastructure, data management, and per-patient capitation to sites for participants enrolled in network studies.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive applications.
The intended RFA is expected to be published in the summer of 2023, with an expected application due date in the Fall of 2023.
The CCC RFA will utilize the UG1 Research Project Cooperative Agreement activity code.
Additional details of the planned RFA are provided below.
This Notice encourages investigators with the experience, knowledge, and skills needed from transplant programs with the commitment and capacity to further the BMT CTN mission to begin to consider applying for the new planned RFA.
The objective of the BMT CTN is to provide an infrastructure for collaborative multi-center clinical research to improve the safety and efficacy of HCT and novel adoptive cell therapies in children and adults with rare and life-threatening non-malignant and malignant blood diseases. In this project period, awardees are expected to mentor early career researchers and clinicians to help them develop into the next generation of leaders in their fields.
CCCs will be expected to advance the development and application of novel therapies and treatment approaches for both non-malignant and malignant blood diseases, to identify optimal HCT strategies and cell therapies, and enroll participants from across demographic groups. Results from trials are expected to be widely disseminated and to improve the scientific basis of care for affected individuals.
This Notice encourages clinical sites with the resources, infrastructure, and expertise to perform the activities listed below to consider applying to be a CCC. Successful applications will:
Since a broad referral network and high participant flow are needed for the success of trials enrolling adult and pediatric participants with rare blood diseases, potential applicants are encouraged to partner in consortia with medical institutions and transplant programs that serve children, adults, individuals from under-represented racial and ethnic groups, and from geographically diverse areas. To enable the rapid collection of data (considering efficiency, timeliness, and cost) and to simplify regulatory processes, it is anticipated that the CCCs will be restricted to U.S. based sites under a sIRB.
Each CCC application should include investigators with expertise in hematology, stem cell transplantation/oncology and cell therapy, including genetically-modified cells. To help maintain a vibrant investigator community, the CCC application must commit to mentoring at least one named early- or mid-career researcher to provide the experiences and hone the skills needed to conduct and lead a multi-center clinical trial and to become a productive, skilled, and knowledgeable investigator capable of leading a network CCC in the future. Funds to help support BMT CTN-wide career enhancing opportunities for these earlier-stage investigators will be planned in the DCC budget. The BMT CTN Steering Committee will determine ways that the funds will be allocated shortly after the start of funding under this RFA.
Up to $4,320,000 total costs for FY2024
Up to $150,000 per award in FY2024
Applications are not being solicited at this time.
Please direct all inquiries to:
Nancy L. DiFronzo, PhD
NHLBI, Division of Blood Diseases and Resources