TL38: Challenges faced by Oncology Statisticians in the area of innovation
*Grazyna Lieberman, Genentech 

Keywords: Clinical Statistician, Innovation, oncology drug development

Advanced technologies in human tumor profiling have led to new targeted oncology therapeutics. With these advances, drug development is becoming increasingly focused on patient selection and/or NME combination strategies. If these strategies are employed in early stages of development and are successful, then large treatment effects can be observed early. This in turn, leads to accelerated development strategies. In parallel to these research and development advances, the following new trends emerge: data transparency, easier access to real world data, broader access to specialized computer software making data exploration easier for non-statisticians, or making complex adaptive designs look simple. The above leads to changes in the environment of oncology drug development and with it comes a strong desire to change how we design and conduct trials, how we make decisions through out the development cycle. There is a pressure on statisticians to be “innovative” by designing adaptive trials. Is this however, the only innovation we can bring to drug development? During our lunch table discussion we will explore what innovation in oncology drug development means to you and how clinical statisticians can be innovative.