IDDI organized a webinar on Personalized Cancer Medicine Needs Randomized Trials.
Clinical cancer research is undergoing profound changes, mostly because of the advent of personalized cancer medicines. Some remarkably efficacious drugs have even been approved based on uncontrolled phase I clinical trials.
In this webinar, our speakers challenged the view that the expected benefits from new personalized cancer medicines are generally sufficient to forgo randomization to a standard-of-care arm.
Personalized Cancer Medicine Needs Randomized Trials
- In this webinar, our speakers challenged the view that the expected benefits from new personalized cancer medicines are generally sufficient to forgo randomization to a standard-of-care arm. Apparently improved outcomes in a single-arm early trial may be due to the prognostic nature of the target and to selection bias, rather than result from a true effect of therapy. Moreover, the predictive role of biomarkers cannot be ascertained in a definitive way without randomization to a control arm.
- They started by reviewing the evolving nature of clinical research, especially with targeted agents, and the very promising examples of the approach to developing personalized cancer medicines. Then they claimed that randomization is an essential feature of clinical trials throughout the continuum of clinical drug development and discuss the potential loss of a clear demarcation between traditional phases of this development.
- Implementing randomization throughout the continuum of development requires important statistical considerations, adaptive designs, and a change of focus from the drug alone to the drug/patient match.
SPEAKERS:
