Refining eligibility criteria for amyotrophic lateral sclerosis clinical trials.

ABSTRACT: To assess the effect of eligibility criteria on exclusion rates, generalizability, and outcome heterogeneity in amyotrophic lateral sclerosis (ALS) clinical trials and to assess the value of a risk-based inclusion criterion. A literature search was performed to summarize the eligibility criteria of clinical trials. The extracted criteria were applied to an incidence cohort of 2,904 consecutive patients with ALS to quantify their effects on generalizability and outcome heterogeneity. We evaluated the effect of a risk-based selection approach on trial design using a personalized survival prediction model. We identified 38 trials. A large variability exists between trials in all patient characteristics for enrolled patients (p < 0.001), except for the proportion of men (p = 0.21). Exclusion r

SUBMITTER: van Eijk RPA 

PROVIDER: S-EPMC6369899 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature