Other Talks in the Series: Adaptive Clinical Trial Design

Other Talks in the Series: The Risk of Bias in Randomized Clinical Trials

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Hi, my name is Anastasia Ivanova from the Department of Biostatistics, University of North Carolina at Chapel Hill. And today, we're gonna talk about Adaptive Designs for Phase I Trials. These designs were developed and are used in Phase I trials in oncology. Some of these designs can be used in Phase I and mostly Phase II trials in areas other than oncology. Since these designs are mostly used in oncology, I will focus on oncology applications throughout this lecture.
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In oncology, we usually consider several fixed doses from three to eight. And we assume that the probability of toxicity is non-decreasing with the dose. Here, on this plot, I have a curve showing the probability of toxicity as a function of dose. The goal of a Phase I trial in oncology is usually to find the Maximum Tolerated Dose or MTD. The MTD is defined as a dose with a certain probability of toxicity, usually 20%. In oncology, the primary outcome in dose-finding studies is actually the Dose Limiting Toxicity, but I will use these two terms interchangeably DLT or toxicity.