TL33: Real-Time Data Analysis for Early Hematology and Oncology Trials
*Shaoyi Li, Celgene Corp. 

Keywords: Real-Time Data Analysis, hematology and oncology, Phase I trials

In the hematology and oncology area, many Phase I trials are open-label and 1st-in-human to find out the maximum tolerable dose. Due to the toxicity of experimental drugs, such trials need to be closely monitored. Clinicians often request various data analyses while trials are still ongoing. In order to meet the demand, we worked with clinicians and came up with a framework of real-time data analysis. The idea is to solve the problem in a systematic way that is efficient and resource saving. However, there are a lot of challenges not only for planning real-time data analysis but also for the “building blocks” that are crucial to support the true real-time data analysis. Here is a short list of the challenges: 1. Relevant real-time data analyses 2. Early development of SAP and shell specifications 3. Biomarker data handling 4. Real-time data capability These are interesting and yet practical topics for a round table discussion. The real-time data analysis truly needs a multidisciplinary effort. It demands some fundamental changes on certain traditional way of practice in the pharmaceutical industry as well.