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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.
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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.
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Background. We'll go over the objective of phase II trials.
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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.
