Participation in U.S.-Based ALS Clinical Trials by Sex and Race.

ABSTRACT:

Introduction/aims

In global amyotrophic lateral sclerosis (ALS) trials, women and men appear to be proportionately enrolled, but quantification of enrollment by sex and race in U.S.-based ALS trials is limited. The objective of this study was to evaluate the sex and race of participants enrolled in U.S.-based ALS clinical trials.

Methods

Participant demographics were extracted from recent U.S.-based Phase 2 and 3 ALS trials identified in literature and on ClinicalTrials.gov. The Centers for Disease Control and Prevention (CDC) National ALS Registry and a 2014 State Surveillance Project were used as proxies for prevalence. Participation-to-prevalence (PPR) ratios were calculated for sex and race. A modified time-trend analysis was performed for race for participants enrolled

SUBMITTER: Levine MP 

PROVIDER: S-EPMC12689998 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature