Assessing treatment efficacy in early-phase oncology trials скачать в хорошем качестве

Assessing treatment efficacy in early-phase oncology trials

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 MORE RESOURCES: https://www.iddi.com/ FOLLOW US!