Who’s Involved

Committees and Centers

The BMT CTN is led by experts in the field of hematopoietic cell transplantation (HCT) and cellular therapy who collaborate to achieve common goals. These experts include:

A Data and Coordinating Center with a long history of supporting research in HCT and cellular therapy that handles overall coordination, administration of studies and statistical design
Expert clinicians and clinical programs in hospitals at BMT CTN Core and Affiliate Clinical Centers across the US where studies are conducted
Collaborators at the National Heart Lung and Blood Institute (NHLBI) and the National Cancer Institute (NCI)

Much of the work of the BMT CTN is done by members of key Network Committees, listed below.

Data and Coordinating Center (DCC)

The BMT CTN Data and Coordinating Center (DCC) handles the overall coordination and administration of the BMT CTN program. Three organizations with extensive hematopoietic cell transplantation (HCT) and cellular therapy research experience manage the DCC.

The DCC is a collaboration of:

Medical College of Wisconsin (MCW)^*
NMDP^*
The EMMES Company (EMMES)

* MCW and NMDP collaboratively operate the Center for International Blood and Marrow Transplant Research (CIBMTR).

The DCC supports and manages the efficient development, implementation, and completion of high-quality Phase II and III clinical trials for the Network by:

Evaluating study concepts
Developing protocols with appropriate statistical designs that are operationally feasible
Facilitating review by independent experts, including a Protocol Review Committee, Data Safety and Monitoring Board, single Institutional Review Board and, where necessary, the Food and Drug Administration and other regulatory bodies
Activating studies and developing plans to accrue in a timely manner
Monitoring for safety and for regulatory and protocol compliance
Collecting complete and accurate clinical, laboratory, and patient-reported outcomes data
Analyzing and sharing research results

Core Clinical Centers

Twenty institutions were awarded grants (cooperative agreements) by the National Heart, Lung, and Blood Institute and the National Cancer Institute to participate as Core Clinical Centers in the BMT CTN. Several of these grants were awarded to consortia of two or more centers. Core Center Principal Investigators, along with the NHLBI Program Officer, NCI Program Officer and the three DCC PIs have voting membership on the BMT CTN Steering Committee. The Steering Committee is responsible for the operation of the Network. The Steering Committee formulates and implements all policy decisions related to the work of the BMT CTN and establishes its scientific agenda.

The BMT CTN Core Clinical Centers bring the highest level of commitment and participation to the Network and facilitate collaboration among researchers, transplant center staff, and support personnel. The Network offers opportunities for patients across the US to access trials, and it provides a forum for shared ideas and resources for research. The heterogeneity of the community improves study validity. New approaches are tested in the broad range of centers in which they are ultimately applied.

Core Clinical Center staff carry out the provisions of the Manuals of Procedures and BMT CTN protocols and recruit, evaluate, and treat study participants. They are responsible for collecting all clinical, laboratory, demographic, and other data required by each BMT CTN study, including long-term follow-up. The Principal Investigator for each Core Clinical Center is directly responsible for ensuring that all aspects of BMT CTN protocols are followed. Other key center staff include other physicians, Co-Investigators, Clinical Research Associates/Coordinators, pharmacists, and related staff.

A list of Core Clinical Centers and Principal Investigators for the current project period, July 2017 through June 2024, may be seen here. As noted above Several Core Clinical Centers are Consortia of 2 or more centers.

Affiliate Centers

Participation in Network trials may be open to qualified centers other than Core Clinical Centers. These centers are referred to as “Affiliate Clinical Centers.” The DCC actively recruits appropriate Affiliate Clinical Centers for Network protocols within the limits of financial resources and in accordance with accrual needs of each protocol. Affiliate Clinical Centers are subject to the same quality assurance procedures as Core Clinical Centers.

Individuals with relevant expertise from Affiliate Clinical Centers may be nominated to participate in BMT CTN Technical Committees and Protocol Teams. Terms are the same as for individuals from Core Clinical Centers. Technical Committees and Protocol Teams are encouraged to have at least one Affiliate Clinical Center representative.

Affiliate Centers may earn voting representation on the Steering Committee for a renewable term of 2 years by exemplary performance in advancing the mission of the BMT CTN. At a minimum, this requires enrolling at least 12 patients on at least 2 Network trials during the previous year.

Steering Committee

The BMT CTN Steering Committee sets the Network’s scientific agenda and oversees the selection, design, execution, and analysis of all BMT CTN studies. Steering Committee members include leaders from a broad range of US transplant centers, which together conduct 77% of allogeneic hematopoietic cell transplantations in the country. The Committee meets monthly, three times a year in person (when possible), and otherwise by videoconference.

The Steering Committee consists of:

Principal Investigators from Core Clinical Centers
Representatives of high-performing Affiliate Centers selected by the Steering Committee
NHLBI and NCI Project Officers
DCC Principal Investigators (MCW, NMDP, Emmes)
Representatives from the cooperative groups of the National Clinical Trials Network: ECOG-ACRIN, SWOG, Alliance for Clinical Trials in Oncology, and Children’s Oncology Group

The Steering Committee elects a Vice-Chair to a one-year term, followed by one-year term as Chair-elect, a two-year term as Chair and a one-year term as Immediate Past-Chair. At any given time, therefore, the Steering Committee Officers comprise a Chair, a Vice-Chair and either a Chair-elect or Immediate-Past Chair, all of whom must be Principal Investigators of Core Clinical Centers.

Executive Committee

The Executive Committee comprises the Steering Committee Chair, Vice-Chair, Chair-elect or Immediate Past-Chair, National Heart, Lung, and Blood Institute and National Cancer Institute Project Officers, and the DCC Principal Investigators. The Committee develops Steering Committee agendas and recommendations for the Steering Committee’s consideration. The Executive Committee provides direction between meetings of the Steering Committee and reviews/approves all non-protocol-specified ancillary studies and secondary analyses. The Executive Committee also provides an initial review of proposals for trials submitted for consideration by the BMT CTN to determine suitability for the Network. The Executive Committee meets monthly by video teleconference.

Protocol Teams

A Protocol Team is appointed for each approved Study Concept. The Protocol Team has primary responsibility for developing all protocol documents and meets weekly-monthly by teleconference throughout the lifecycle of the study.

The Protocol Team consists of:

Protocol Chair(s)
Core and Affiliate Clinical Center Investigators (3 or more)
Protocol Officer (DCC physician)
Primary Protocol Statistician (DCC statistician)
Protocol Coordinator (DCC Coordinator)
National Heart, Lung and Blood Institute (NHLBI) and National Cancer Institute representatives (1 each)
NHLBI Statistician (1)
DCC Business Representative
Ad hoc members as deemed necessary by the Protocol Chair(s) and DCC

Technical Committees

Ad hoc Technical Committees conduct specified functions of Network activity, advise the Steering Committee on Network policies and procedures, and provide technical expertise for protocol design. Each Technical Committee has a DCC representative responsible for coordinating Committee conference calls and meetings. Each also has a representative from the National Heart Lung and Blood Institute (NHLBI) and the National Cancer Institute (NCI). The DCC representative works with the Committee Chair to prepare and distribute an agenda and minutes for each meeting and to ensure that the Committee’s findings are communicated to protocol teams, where appropriate (see below). The Network solicits nominations for Technical Committee members annually from participating Core and Affiliate Clinical Centers. Committee members consist of a maximum of ten members who are not associated with the DCC, NHLBI or NCI and are appointed by the Nominating or Executive Committee to three-year terms. The Steering Committees approve candidates to fulfill the 3-year term.

The following Technical Committees must review all BMT CTN protocols at some point in their development but no later than time of submission to the Protocol Review Committee: Biomarkers, Clinical Research Associates, Pharmacy, Special Populations, and Toxicity and Supportive Care.

Biomarkers Committee
The Biomarkers Committee comprises Core and Affiliate Center transplant physicians and seeks to:

Inform the Network’s scientific agenda focusing on questions involving analysis of biologic specimens for genomic and proteomic markers
Establish principles for specimen collection (including their use in Ancillary Studies)
Review new and existing studies for opportunities to collect blood and tissue samples for analysis of potential prognostic markers
Advise the Network protocol teams in their review of ancillary study proposals that request the use of BMT CTN-related research samples