New Research Article Published in the October
Issue of the Journal for ImmunoTherapy of Cancer
Statistical Issues and Challenges in
Immuno-oncology
Tai-Tsang Chen, EdM, PhD
Journal for ImmunoTherapy of Cancer 2013, 1:18 (21 October 2013)
The development of immuno-oncologic agents poses unique challenges, namely that both efficacy and safety profiles differ from previously characterized cytotoxic and pathway-specific agents. In addition, exponential distribution is usually assumed in study designs with time-to-event endpoints such as overall survival or progression-free survival. This assumption might lead to wrong estimates of study duration and statistical power if the phenomena of long term survival and delayed clinical effects are present. The aim here was to evaluate the magnitude of the impact caused by the violation of this assumption, and to describe new ways of analyzing efficacy and safety of immuno-oncologic agents.
"This article highlights the importance of fully understanding the characteristics of the compounds under investigation, especially immune-oncologic agents, in order to determine the optimal trial design and selection of the best endpoints, as well as the most appropriate efficacy and safety analysis approaches," Dr. Chen said.
Click here to read the full abstract and article in JITC.
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Highly Accessed Article Update 
The research article, Turning T cells on: Epigenetically Enhanced Expression of Effector T-cell Costimulatory Molecules on Irradiated Human Tumor Cells by Anita Kumari, Ercan Cacan, Susanna F Greer and Charlie Garnett-Benson, has reached highly accessed status with over 1,010 views since its publication in JITC less than one month ago. Congratulations to these authors! To read this article as well as other highly accessed articles in JITC, please visit: www.sitcancer.org/journal.
