Phase II trials

Published on June 29, 2021   46 min

Other Talks in the Therapeutic Area: Oncology

0:00
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.
0:17
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.
0:40
Background. We'll go over the objective of phase II trials.
0:46
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.