Course: Estimated Clinical Trial Capacity of Sites Participating in the COVID-19 Convalescent Plasma Expanded Access Program
CME Credits: 1.00
Released: 2022-10-19
Expanded access (EA) allows patients to receive unapproved medicines outside trials only if doing so would not interfere with drug development. However, interference may not be obvious: is EA needed because a site lacks trial capacity, or is EA inhibiting trial initiation? These questions were highlighted in the context of the largest-ever EA program (EAP), implemented for COVID-19 convalescent plasma (CCP). The program was initially planned for 5000 patients but ultimately enrolled 105,717 patients. We sought to estimate the trial capacity of participating CCP EAP sites, hypothesizing that many sites could have supported CCP research to better guide clinical care.
Educational Objective
To identify the key insights or developments described in this article
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