Interpreting clinical trial outcomes complicated by placebo response with an assessment of false-negative and true-negative clinical trials in depression using propensity-weighting.

ABSTRACT: The objective of this study was to evaluate the performances of the propensity score weighted (PSW) methodology in a post-hoc re-analysis of a failed and a negative RCTs in depressive disorders. The conventional study designs, randomizations, and statistical approaches do not account for the baseline distribution of major non-specific prognostic and confounding factors such as the individual propensity to show a placebo effect (PE). Therefore, the conventional analysis approaches implicitly assume that the baseline PE is the same for all subjects in the trial even if this assumption is not supported by our knowledge on the impact of PE on the estimated treatment effect (TE). The consequence of this assumption is an inflation of false negative results (type II error) in presence of a high p

SUBMITTER: Gomeni R 

PROVIDER: S-EPMC10721911 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature