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Expanded access protocol (EAP) program for access to investigational products for amyotrophic lateral sclerosis (ALS).

Megan YertonAllison WinterDario GelevskiGrace AddyAnthony KostovCassandra LiebermanHarli WeberMichael DoyleGeli KaneCaroline CohenNeil ParikhKatherine M BurkeMargot RohrerTaylor StirratMargaret BrunoAlison HochmanSarah LuppinoJennifer ScaliaDerek D'AgostinoErvin SinaniHong YuKristin DrakeJennifer HagarAlexander V ShermanSuma BabuJames D BerryMerit E CudkowiczSabrina Paganoni
Published in: Muscle & nerve (2023)
EAPs provide a framework through which access to IP can be safely provided to people with ALS who do not qualify for clinical trials. Site resources are needed to launch and maintain these programs. This article is protected by copyright. All rights reserved.
Keyphrases
  • amyotrophic lateral sclerosis
  • clinical trial
  • phase ii
  • randomized controlled trial
  • quality improvement
  • public health
  • open label
  • study protocol