0:00
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.
0:36
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.
1:29
So as I said,
the Maximum Tolerated Dose
is defined as the dose
where the probability of toxicity
is equal to a certain number
but you know this number as Γ.
And Γ is usually 20%
in Phase I trials in oncology.
