Identifying Anticipated Events of Future Clinical Trials by Leveraging Data from the Placebo Arms of Completed Trials.

ABSTRACT:

Background

An important component of a systematic strategy for safety surveillance is prospective identification of anticipated serious adverse events (SAEs). Developing a structured approach to identify anticipated events and estimating their incidence can help align the safety strategy and the safety surveillance efforts.

Methods

We developed a novel approach to identify anticipated events for a hypothetical randomized, double-blind, controlled trial in subjects with bipolar disorder using the adverse events reported in the placebo arm of trials from the ClinicalTrials.gov database. We searched the ClinicalTrials.gov database for all trials on bipolar depression with similar inclusion/exclusion criteria and study duration as our hypothetical study. The frequencies of antic

SUBMITTER: Tan XL 

PROVIDER: S-EPMC7864837 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature