Assessing treatment efficacy in early-phase oncology trials
February 3, 2022
Join IDDI experts to get updated on efficacy assessment in early-phase trials and more!
One of the major recent trends in drug development in oncology, particularly with highly targeted therapy and immunotherapy, is a great concern with efficacy assessment in early phases of development. This was not frequent before the era of precision medicine. As a result, phase 1 trials now routinely have efficacy endpoints and even sample-size justification related to efficacy, particularly in expansion cohorts.
In this webinar, we will:
– Present a historical overview of efficacy assessment in early-phase trials
– Highlight some recent regulatory trends in that respect
– Discuss the tension between the clinically appealing and statistically sound methods to assess the efficacy of novel treatments in phase 1 trials, single-arm phase 2 trials, and randomized phase 2 trials
Errata: At 8’17’’ and 8’57’’, the speaker mentions “safety”, when in fact what was meant was “efficacy”. The speaker apologizes for these mistakes.