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.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC