Gender differences in the response to antipsychotics or mood stabilizers in patients with acute mania: An individual patient data meta-analysis of placebo-controlled studies.

Evidence suggests a worse clinical course in women compared to men with bipolar disorder. However, little research has explored gender differences in the efficacy of anti-manic medication. We sought to determine whether there are gender differences in efficacy of drug treatment in acute manic episodes of bipolar I disorder, and the influence of dichotomized age as a proxy for menopausal status and baseline severity on gender differences.

Stakeholders' Perspectives on Current Issues in Data Monitoring Committees.

Data Monitoring Committees (DMCs) are groups of experts that review accumulating data from one or more ongoing clinical studies and advise the Sponsor regarding the continuing safety of study subjects along with the continuing validity and scientific merit of the study. Although DMCs are widely used, considerable variability exists in their conduct. This paper offers recommendations, derived from sessions given at the 2023 Central European Network International Biometric and Statisticians in the Pharmaceutical Industry Conferences' and the authors' experiences.