Utility-Based Dose Selection for Phase II Dose-Finding Studies.

Background And Objectives: Dose selection is a key feature of clinical development. Poor dose selection has been recognized as a major driver of development failure in late phase. It usually involves both efficacy and safety criteria.

Design optimization for dose-finding trials: a review.

Dose selection is one of the most difficult and crucial decisions to make during drug development. As a consequence, the dose-finding trial is a major milestone in the drug development plan and should be properly designed. This article will review the most recent methodologies for optimizing the design of dose-finding studies: all of them are based on the modeling of the dose-response curve, which is now the gold standard approach for analyzing dose-finding studies instead of the traditional ANOVA/multiple testing approach.

Late-life depression and mortality: influence of gender and antidepressant use.

Background: Depression may increase the risk of mortality among certain subgroups of older people, but the part played by antidepressants in this association has not been thoroughly explored.

Aims: To identify the characteristics of older populations who are most at risk of dying, as a function of depressive symptoms, gender and antidepressant use.

Method: Adjusted Cox proportional hazards models were used to determine the association between depression and/or antidepressant use and 4-year survival of 7,363 community-dwelling elderly people.