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This talk is on phase II clinical trial design.
My name is Patricia Tang,
I'm a medical oncologist at the Tom Baker Cancer Centre in Calgary, Alberta, Canada,
and I'm a clinical associate professor in the medical school.
Today we'll go over the objective of phase II trials,
the clinical trial endpoints for the trials,
as well as different phase II trial designs, including single-arm phase II trials,
randomized phase II trials, phase II/III or phase I/II trials, as well as enrichment designs.
Background. We'll go over the objective of phase II trials.
The traditional paradigm of drug development moves from phase I,
where a new drug is evaluated for the appropriate dose,
scheduling of delivery, as well as toxicity,
and at the end of the phase I trial, we arrive at the recommended phase II dose,
which is sometimes also called the maximum tolerated dose.
The phase II trial objective, which is the topic of today,
is a signal of drug activity, worthy of moving forward to phase III.
In a phase III clinical trial, we evaluate the superiority of a novel agent
or regimen on patient outcomes, compared to the standard therapy.
Phase IV trials are sometimes conducted as a post-marketing evaluation.
As we move from phase I to IV, this requires an increasing number of patients, and of course, cost.
The number of drugs that are successful through each phase of drug development decreases.