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Review
. 2021 Feb 10;39(5):534-544.
doi: 10.1200/JCO.20.01623. Epub 2021 Jan 12.

Building a Fit for Purpose Clinical Trials Infrastructure to Accelerate the Assessment of Novel Hematopoietic Cell Transplantation Strategies and Cellular Immunotherapies

Steven M Devine  1   2 , Mary M Horowitz  3   4
Affiliations
Review

Building a Fit for Purpose Clinical Trials Infrastructure to Accelerate the Assessment of Novel Hematopoietic Cell Transplantation Strategies and Cellular Immunotherapies

Steven M Devine et al. J Clin Oncol. .
No abstract available

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Figures

FIG 1.
FIG 1.
(A) The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is composed of a network of organizations that work together to achieve common goals. It includes the following elements: Data and Coordinating Center (DCC), 20 Core Centers/Consortia, a network of affiliate centers, Steering Committee, protocol teams, technical committees, administrative committees, ad hoc committees, and National Heart, Lung, and Blood Institute (NHLBI) review committees. These are described in greater detail in the BMT CTN Annual Progress Report. (B) This depicts the delineation of responsibilities between the three organizations that compose the DCC. Several are overlapping. CIBMTR, Center for International Blood and Marrow Transplant Research; IRB, institutional review board; NCI, National Cancer Institute; NMDP, National Marrow Donor Program.
FIG 2.
FIG 2.
Once formed, the protocol team typically holds weekly calls managed by a Data and Coordinating Center (DCC) protocol coordinator. Calls follow an 8- to 12-week development process wherein each chapter of the protocol is assigned to specific team members and with deadlines for completion. Once approved by the Steering Committee (SC), each protocol undergoes independent scientific review by the protocol review committee (PRC) and review by the Data and Safety Monitoring Board (DSMB). Metrics include time from protocol team formation to DSMB approval, which can be ≤ 6 months for industry-sponsored studies. Once protocols are released to sites, it should take < 180 days to site activation and 56 days from protocol activation to first patient enrolled. IRB, institutional review board; NMDP, National Marrow Donor Program.
FIG 3.
FIG 3.
Blood and Marrow Transplant Clinical Trials Network (BMT CTN) revenue by year. The graph depicts the growth in industry support for BMT CTN studies from 2012 to 2019. FY, fiscal year; NHLBI, National Heart, Lung, and Blood Institute.
See this image and copyright information in PMC

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