Clinical Trials, Ahead of Print. Background:Although the hazard ratio has no straightforward causal interpretation, clinical trialists commonly use it as a measure of treatment effect.Methods:We review the definition and examples of causal estimands. We discuss the causal interpretation of the hazard ratio from a two-arm randomized clinical trial,...

Clinical Trials, Ahead of Print.

Clinical Trials, Ahead of Print.

Clinical Trials, Ahead of Print. Introduction:Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation...

Clinical Trials, Ahead of Print. This article reviews the implementation challenges to the American Society of Clinical Oncology’s ethical framework for including research biopsies in oncology clinical trials. The primary challenges to implementation relate to the definitions of secondary endpoints, the scientific and regulatory framework, and the...

Clinical Trials, Ahead of Print. Background/aimsWhen designing a cluster randomized trial, advantages and disadvantages of tentative designs must be weighed. The stepped wedge design is popular for multiple reasons, including its potential to increase power via improved efficiency relative to a parallel-group design. In many realistic settings, it...