Assessing Heterogeneity of Treatment Effect in Real-World Data.

ABSTRACT: Increasing availability of real-world data (RWD) generated from patient care enables the generation of evidence to inform clinical decisions for subpopulations of patients and perhaps even individuals. There is growing opportunity to identify important heterogeneity of treatment effects (HTE) in these subgroups. Thus, HTE is relevant to all with interest in patients' responses to interventions, including regulators who must make decisions about products when signals of harms arise postapproval and payers who make coverage decisions based on expected net benefit to their beneficiaries. Prior work discussed HTE in randomized studies. Here, we address methodological considerations when investigating HTE in observational studies. We propose 4 primary goals of HTE analyses and the corres

SUBMITTER: Segal JB 

PROVIDER: S-EPMC10273137 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature