Publication Date
1-1-2024
Journal
Journal of Clinical and Translational Science
DOI
10.1017/cts.2024.642
PMID
39655012
PMCID
PMC11626586
PubMedCentral® Posted Date
11-14-2024
PubMedCentral® Full Text Version
Post-print
Published Open-Access
yes
Keywords
COVID-19, convalescent plasma, decentralized clinical trial, clinical trial management, supply chain management, investigational drug services, cloud-based platform
Abstract
INTRODUCTION: In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.
METHODS: A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.
RESULTS: We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.
CONCLUSION: The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.
Included in
Clinical Epidemiology Commons, COVID-19 Commons, Diseases Commons, Infectious Disease Commons, Medical Sciences Commons