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
Date: Thursday, February 3rd, 2022
Time: 9:00 – 10:00
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.
|8:50||Online platform opens for registering participants|
David Munis Zepernick, Head of Business Development and Public Affairs, Medicon Valley Alliance
|9:05||Assessing treatment efficacy in early-phase oncology trials|
Everardo Saad, MD, Medical Director at the International Drug Development Institute, IDDI
Moderated by Erik Falvey, Senior Director Business Development Europe at the International Drug Development Institute (IDDI)
|10:00||End of webinar|
|Erik Falvey, Senior Director Business Development Europe at the International Drug Development Institute, IDDI|
|Organized by||In collaboration with|