Use of joint models to assess treatment effects on disease markers and clinical events: the ProscarTM Long-Term Efficacy and Safety Study (PLESS)

Abstract

Clinical trials often collect longitudinal measurements of a disease marker and time to a major clinical event of the disease to assess treatment effects. It makes sense to combine the treatment effects on both the longitudinal disease marker and the time to clinical event, especially when the clinical event is also mediated through the disease marker over time. In this paper we apply a joint modeling approach in the assessment of the treatment effects in treating benign prostatic hyperplasia (BPH) for the Proscar^TM Long-Term Efficacy and Safety Study (PLESS).

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