5 session picks for the JSM

July 20, 2016


The Joint Statistical Meetings is the largest and arguably most highly respected gathering of statisticians in the world.  It will bring together over 6000 statisticians for this year’s event in Chicago.   As a large meeting, it can be a challenge to navigate and find the sessions which are going to be most valuable for your work.  To help out, we've asked some of the leading lights of our statistical group which sessions are their top picks this year. 

212623 Making Quantitative Decisions During the Clinical Development of a New Drug

Sunday, July 31, 2016 : 1:00 PM to 5:00 PM

We’ve previously explored in the blog the importance of robust, quantitatively guided decision making in drug development and shared resources by Astrazeneca on their approach to this issue. Led by Christy Chuang-Stein, this course looks to be an interesting pick for those interested in how to apply quantitative decision making at proof-of-concept, dose-response, and confirmatory stages of clinical development.

251   Use of Bayesian Methods in Dose-Escalation Studies Use of Bayesian Methods in Dose-Escalation Studies

Monday, August 1, 2016 : 2:00 PM to 3:50 PM

Mani Lakshminarayanan of Pfizer will discuss Bayesian model-based approaches including the continual reassessment method (CRM), a framework similar to CRM with a set of decision rules called toxicity probability interval (TPI) approach and a dose escalation with overdose control (EWOC) method.  While of particular interest to Cytel statisticians in the light of recent developments with East Escalate module, this session is sure to be of general interest to statisticians working in early phase development.


The rest of the session 251 explores other Bayesian approaches, including an interesting session on Bayesian based go/no-go decision-making by Rodney Croos-Dabrera* and Misun Lee of Astellas Pharma.


397 Innovative Trial Designs and Data Analysis Models in Rare Diseases

Tue, 8/2/2016, 2:00 PM - 3:50 PM

This looks like a particularly engaging session for those interested in the innovative and adaptive approaches which often feature in rare disease development.  The session is organized and chaired by Freda Cooner of the FDA and features presentations by Jeff Palmer of Pfizer, John Scott of the FDA, a team led by Brenda Gaydos of Eli Lilly and Cynthia Basu of the University of Minnesota.  Rare diseases development frequently features the most innovative approaches including adaptive designs. As part of his own presentation, John Scott plans to discuss Bayesian and adaptive approaches in rare disease development which specifically assess the safety of products for small populations.

Read our case study about a successful orphan disease trial 

596  Improved Design and Analysis in the Clinical Development of Cancer Immunotherapies

Bo Huang* and Margarida Geraldes, Pfizer

Wednesday, August 3, 2016 : 2:00 PM to 3:50 PM

Immunotherapy was selected by ASCO as the clinical advance of the year in February 2016.  This exciting area of clinical development raises statistical issues, in particular how to accurately measuring efficacy and safety due to the unique mechanisms of action.   This presentation at JSM seeks to address this issue by recommending improved designs, endpoints and analysis methods to optimize both safety and efficacy evaluations of these novel agents.

The rest of this session will also be of interest to biostatisticians working in the oncology field

 Cytel contributed sessions

Cytel statisticians will also be contributing to a number of sessions related to innovative methods in trial design and execution. These sessions include insights on go/no decision-making, blinded data reviews, and Bayesian approaches.  We are also delighted to be leading 2 workshops in East on Wednesday 3rd August.

2016_Q2_Conference_Header_image_JSM_chicago_2016.jpg(213245) Multi-Arm, Multi-Stage Trials with Treatment Selection and Sample Size Re-Estimation 

Led by Cyrus Mehta and Lingyun Liu

1:00 PM - 2:45 PM

 (213248 )Designing Phase 1 Dual-Agent Dose Escalation Phase 1 Trials 

Led by Hrishikesh Kulkarni and  Charles Liu

 3:00 PM - 4:45 PM

To find out more about Cytel sessions and workshops at JSM click below and don't forget to visit us at Booth 429. See you in Chicago! 

Sessions & Workshops