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Development, Regulatory, & Outcomes (DRO) Network

Network Goals

  • Enhance communication, cross-training and collaborations among members from multiple sectors including industry, government, and academia.
  • Apply principles of clinical pharmacology in the continuum of drug development, regulation, and post-marketing research and surveillance, as well as safe and effective utilization of medicines.

Upcoming Community Webinars
ASCPT Early Development & Drug Safety (EDDS) and Oncology (ONC) Communities Members-Only Webinar
Title: Using Preclinical Data in Phase I Oncology Trials: A Bayesian Decision-Theoretic Approach
Date and Time: Tuesday, September 1, 2020, 11:00 AM ET
Speaker: Haiyan Zheng, PhD
Moderator: Huiming Xia, MSc, PhD
Description: Using preclinical data to specify a prior for the human dose-toxicity model parameter(s) can improve interim dose recommendations and precision for estimating the maximum tolerated dose (MTD). Such advantages, however, must be balanced against the risk that more patients will possibly be treated with excessively toxic doses in the case of a prior-data conflict. This presentation will make a proposal for how to measure and address a prior-data conflict in a sequential study with a small sample size. For learning objectives and additional description information, please click the registration link below.
Registration Link: 
https://us02web.zoom.us/webinar/register/WN_Uw-PHaVcRnuDTZwa1AfNiw

Past Webinars

Anuradha Ramamoorthy, PhD

Network Chair

 

J Liu

Jing Liu, PhD

Network Vice Chair

 

Robin O'Connor-Semmes, PharmD, PhD

Network Past Chair

 

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