Multicenter expanded access program for access to investigational products for amyotrophic lateral sclerosis
Dylan V. Neel,
Clara Baselga‐Garriga,
Molly Benson
et al.
Abstract:Introduction/AimsExpanded access (EA) is a Food and Drug Administration‐regulated pathway to provide access to investigational products (IPs) to individuals with serious diseases who are ineligible for clinical trials. The aim of this report is to share the design and operations of a multicenter, multidrug EA program for amyotrophic lateral sclerosis (ALS) across nine US centers.MethodsA central coordination center was established to design and conduct the program. Templated documents and processes were develo… Show more
Set email alert for when this publication receives citations?
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.