Exclusion rates and generalizability in amyotrophic lateral sclerosis clinical trials


  • While reducing participation in randomized controlled trials (RCTs) for amyotrophic lateral sclerosis (ALS) considerably, exclusion criteria have only a minimal effect on homogeneity across endpoints.

Why this matters

  • It is important to balance the need to demonstrate drug efficacy through use of exclusion criteria in RCTs, while also ensuring the generalizability of results.