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Abstract:
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The strategic planning of any clinical trial depends upon the rate of patient enrollment and, in the case of survival studies, on the accumulation of a required number of events. Unfortunately, according to one study, "six percent of clinical trials are completed on time, 72% of trials run over schedule by more than one month." (CISCRP: www.fda.gov) At the time of study design, but critically as data accumulate during the trial, predicting these two quantities accurately is of the utmost importance as they affect the overall statistical power, timeline as well as the cost of development. These predictions fall into two categories depending on whether the forecaster is unblinded or blinded to treatment assignment. In this talk, we will focus on blinded prediction, a situation many trial sponsors face. Using a new module of the East® software, we will discuss a case study in which we predict future events, enrollment and study duration using blinded data and contrast it with the unblinded approach.
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