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Abstract:
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A clinical trial is designed to answer a primary question, with a pre-specified analysis of the primary endpoint. Upon completion of a trial, full information is available to answer the question. For clinical trials in which data reviews occur before completion, issues arise that are unique to interim reporting. A typical endpoint may be mortality, a disease-related event such as stroke, or a composite endpoint. In many studies, an adjudication committee formally classifies potential endpoint events reported by trial investigators. During a trial not all events have been adjudicated; thus "unrefuted" or best-available information must be used for analysis, combining adjudication results with reported events. Interim clinical trial data can be missing, inconsistent, or incomplete. Procedures are needed to handle situations such as conflicting, partial, or missing dates; a single event reported as multiple events; censoring for time-to-event analyses; and other analysis concerns. We discuss some of our best practices for presenting useful and coherent analyses to facilitate efficient review of interim endpoint analyses, presenting sample displays commonly used in our reporting.
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