Our Events in 2017

November 2017, ASA traveling short course


Adaptive Designs: Overview, Hurdles, and Examples

Instructor:  Professor Christopher Coffey, University of Iowa


When: Thursday, November 09, 2017, from 9:00 AM to 3:00 PM


East Lecture Hall, Rutgers Robert Wood Johnson Medical School

675 Hoes Lane West, 

Piscataway, NJ 08854


How to Register:

Please use the following link for registration:


Regular registration: $65; student/retiree: $30



Note that refreshments and a lunch buffet are included in each registration, and parking is complimentary and available in Lots A, B & C. Event Parking signage will be at the entrance to Lots A, B & C.


This is a great opportunity for learning and networking. We look forward to seeing you at this exciting event.



Shou-En Lu

President, ASA Princeton-Trenton Chapter

Course Abstract: In recent years, there has been substantial interest in the use of adaptive or novel randomized trial designs.  Adaptive clinical trial designs provide the flexibility to make adjustments to aspects of the design of a clinical trial based on data reviewed at interim stages.  Although there are a large number of proposed adaptations, all generally share the common characteristic that they allow for some design modifications during an ongoing trial.  Unfortunately, the rapid proliferation of research on adaptive designs, and inconsistent use of terminology, has created confusion about the similarities, and more importantly, the differences among the techniques.  Furthermore, the implementation of adaptive designs to date does not seem consistent with the increasing attention provided to these designs in the statistical literature.  This workshop will attempt to clarify some of the confusion surrounding the use of these methods, as well as provide examples where they have been used in the past.   The workshop will be structured in two parts:

  • The first part of the course will provide some clarification on the topic and describe some of the more commonly proposed adaptive designs.  It will also focus on some specific barriers that impede the use of adaptive designs in the current environment, and will discuss future work that is needed in order to ensure that investigators can achieve the promised benefits of adaptive designs.
  • The second part of the course will provide a more in-depth discussion of the theory and implementation of adaptive designs in real-world settings.  The presenter will draw from several recent examples of studies implementing adaptive designs, and will address the strengths and weaknesses of the approaches used.  This part of the course will also summarize the results of a couple of recently completed surveys to assess the interest and attitudes of the clinical trials community in general with respect to the use of adaptive designs.

About the instructor: Dr. Christopher S. Coffey is Professor of Biostatistics and Director of the Clinical Trials Statistical and Data Management Center at the University of Iowa College of Public Health. He received his PhD in biostatistics in 1999 from the University of North Carolina, is a Fellow of the Society for Clinical Trials, and is a 2016 Fellow of the American Statistical Association.  His research interests include linear models, power analyses, sample size re-estimation, adaptive designs, and comparative effectiveness trials. He is nationally recognized for his methodological contributions to the design and analysis of clinical trials as well as his leadership in the coordination and conduct of clinical trials in neuroscience, cardiology, and other disease areas. He has given short courses on adaptive trials to the Society for Clinical Trials, FDA, and other professional organizations.





08:35 - 09:05 AM

Registration, Coffee, Breakfast, and Check In


09:05 - 09:15 AM

Greetings and Introduction

Shou-En Lu,  ASA P-T chapter president

09:15 - 10:30 AM

Adaptive Designs: Overview, Hurdles, and Examples

Professor Christopher Coffey,

University of Iowa

10:30 - 10:45 AM


10:45 AM - 12:00 PM

Adaptive Designs: Overview, Hurdles, and Examples

Professor Christopher Coffey,

University of Iowa

12:00  - 1:00 PM

Lunch Break

1:00  –  1:55 PM

Adaptive Designs: Overview, Hurdles, and Examples

Professor Christopher Coffey,

University of Iowa

1:55 - 2:05 PM


2:05 - 3:00 PM

Adaptive Designs: Overview, Hurdles, and Examples

Professor Christopher Coffey,

University of Iowa


Parking Map







October 2017, Career Day


Are you anticipating a career in Statistics and want to learn about different career paths for statisticians in industry, academia, and government? Are you already working as a statistician and are an intelligent, hardworking, team player, yet you feel that you are stuck in your current role, or would you like to move up in your career? A number of prominent statisticians and senior executives have agreed to share their insights at this career development event. The event will include presentations and a panel discussion that cover a wide range of topics, including successful career development experience, and communications skills for the business world. There will be plenty of networking time to interact with representatives from a number of companies which employ statisticians. 

This free of charge event (including lunch) will be held at the Rutgers RWJ School of Medicine from 8:30 AM to 3:00 PM on Saturday, October 14th.  If you have any questions, please contact Steve Ascher (stelbon@comcast.net) President of the NJ ASA Chapter or Shou-En Lu (sl1020@sph.rutgers.edu) President of the Princeton-Trenton ASA Chapter.

If you plan on attending, please let Steve Ascher know (stelbon@comcast.net) as seating is limited.  Thanks.


Steve Ascher, President of the New Jersey Chapter of ASA

Shou-En Lu, President of the Princeton-Trenton Chapter of ASA


The address of where the event is taking place:

Rutgers RWJ Medical School – East Lecture Hall 
675 Hoes Ln W 
Piscataway, NJ 

Parking: Free for attendees.  Use Rutgers Lot A.  Do not park in visitors or reserved spots.

Walking directions: Cross Hoes Lane West, and walk through Lot C.  Then pass the CABM building walking towards the Research Tower (an eight-story building).  Enter through the revolving doors.  Inside, turn right and enter the Kessler Teaching Laboratories -event is in the East Lecture Hall.

For your information, a campus map is attached below.



Draft Agenda





9:00 – 9:15

Opening Remarks

Shou-en Lu

P-T Chapter ASA President


Steve Ascher

NJ Chapter ASA President

9:15 – 9:40

Pharmaceutical Industry

Len Oppenheimer

9:40 – 10:05

Food and Drug Administration (FDA)

Dionne Price

10:05  – 10:30

Exxon- Mobil

Ming Chen

10:30 – 10:55

Academia (Rutgers)

Tirthankar Dasgupta

10:55 – 11:35

Break for Networking


11:35 – 12:00

Bureau of Labor Statistics

Robin Hildick

12:00 – 1:30

Lunch, Networking, Booths



1:30 – 1:55


Steve Ascher

1:55 – 2:55

Panel Discussion

All Speakers

2:55 – 3:00

Closing Remarks

Shou-en Lu and Steve Ascher





If you plan on attending, please let Steve Ascher know (stelbon@comcast.net).







May, 2017 



  • ASA Prinecton-Trenton Chapter Spring 2017 Symposium


Dear Colleagues,

 The ASA Princeton-Trenton Chapter in New Jersey is organizing a Spring Statistics Symposium from 9:00 AM to 2:30 PM EDT on Friday, May 5, 2017 in the East Lecture Hall, Rutgers Robert Wood Johnson Medical School.

The focus of the Spring Symposium is on New Advancement in Biomarkers/Precision Medicine/Enrichment Design. It aims to introduce participants to the new advancement of statistical methods and applications in precision medicine, to discuss the challenges and solutions related to the use of biomarkers in design and analyses for clinical trials and translational research, and to review present knowledge on biomarkers.

Tentative agenda:




8:30 - 9:00 AM



9:00 - 9:05 AM

Greetings and Introduction

9:05 - 9:50 AM

The Reality of Personalized Oncology – 2017


Richard Simon,Associate Director, Division of Cancer Treatment & Diagnosis, Biometric Research Program

Chief, Computational & Systems Biology Branch, National Cancer Institute

9:50 - 10:35 AM

Statistical Challenges in Precision Medicine with a Focus on Companion Diagnostics


Gregory Campbell,President, GCStat Consulting, LLC. Former Director, Division of Biostatistics, CDRH/FDA

10:35 - 10:50 AM


10:50 - 11:35 AM

Two Novel Designs for Small Populations: The Confirmatory Basket Trial and the Informational Design


Robert A. Beckman, MD,Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics,Georgetown University Medical Center

11:35 - 12:20 PM

Developing an Immunohistochemistry Test for Programmed Cell Death Ligand 1 (PD-L1) as a Companion Diagnostic for Pembrolizumab

Deepti Auroa-Garg,Director, Biomarker and Diagnostics Leader, Merck Oncology

12:20 - 1:30 PM

Lunch Break

1:30 - 2:30 PM

Panel discussion

Richard Simon, Greg Campbell,
Robert A. Beckman,Deepti Auroa-Garg


light breakfast and lunch buffet are provided with registration. The parking lots [Parking Lot A, B, and C] are conveniently located near the event location, and will have Signs indicating event parking. For your information, a parking map is attached. 






1. Richard Simon: The Reality of Personalized Oncology– 2017

Oncology is a set of diseases thought to result in large part from the development of genomic mutations and other DNA alterations. The development of inexpensive DNA sequencing has enabled the development of new cancer classifications based on the presence or absence of genomic alterations. This classification has been strongly correlated with response to molecularly targeted treatment and this has had a profound influence on pharmaceutical drug development strategies. These strategies have led to changes in clinical development plans as the old “aspirin paradigm” is no longer appropriate as a basis for clinical trial design in many cases.


In my talk I will describe some successes in accommodating clinical trial design to developments in cancer biology. I will also describe some remaining challenges such as utilization of quantitative biomarkers, prospective-retrospective studies and designs which adaptively identify the intended use population.


2. Gregory Campbell: Statistical Challenges in Precision Medicine with a Focus on Companion Diagnostics

Since the successful sequencing of the human genome early this century, the public has begun to see practical breakthroughs through advancements in precision medicine; namely, therapeutic medical products tailored to the patient using a biomarker. With the recent genetic and genomic advancements, there has been an explosion in the amount of biomarker data. One statistical challenge is that of co-development: how to confirm that a particular therapeutic product is safer or more efficacious for an individual based on the particular result of a companion diagnostic (usually genomic) test. Various types of diagnostic tests or biomarkers are introduced and illustrated. Another statistical challenge is that of design: how can diagnostic tests and therapeutic products be co-developed, especially if the drug clinical trial precedes the development of a market ready diagnostic test to be used in concert with the drug. Statistical designs that allow for adaptation or for the use of retrospective data in a scientifically valid manner are discussed. Analysis of data from such trials is also challenging, particularly of multiplicity, selection of a cutoff for the test, and missing data. Several drug-diagnostic examples are reviewed and a number of clinical trials are discussed. The implications for the future of individualized medicine are enormous. An interdisciplinary effort involving.


3. Robert Beckman: Two Novel Designs for Small Populations: The Confirmatory Basket Trial and the Informational Design

Two novel designs will be presented, the confirmatory basket trial and the informational design.

Increasingly, tumors are defined on a molecular basis rather than only on histology, and targeted agents which address these molecular subtypes are being approved. This profusion of molecular subtypes creates “rare” diseases as subsets of common cancers, leading to difficulties in enrolling sufficiently large cohorts for confirmatory trials. However, if the molecular subtype is shared across various histologies, these may be pooled into a basket trial. To date, basket trials have been primarily for exploratory early development. We present a new confirmatory basket trial design which will provide patients in niche indications with enhanced access to novel therapies, facilitate development and full approval for niche indications, allow accelerated approval for indications within a basket based on a surrogate endpoint, reduce development cost by combining trials into one, and enhance the ability of regulatory authorities to evaluate risk and benefit in niche indications.

The informational design allows adaptation when the ability of interim endpoints to predict final definitive endpoints is uncertain. A fraction of the patients are designated as an informational cohort and their data governs an adaptation at the end of the study. These patients are also used in the final analysis with suitable alpha adjustment. Applications include alpha allocation between a full population and a subset, setting a threshold for a continuous biomarker, and a speculative application of a confirmatory trial which selects its own primary endpoint. The latter may be useful for rare diseases where the natural history is unknown and difficult to obtain. 



4. Deepti Auroa-GargDeveloping an Immunohistochemistry Test for Programmed Cell Death Ligand 1 (PD-L1) as a Companion Diagnostic for Pembrolizumab


Keytruda® (Pembrolizumab) an anti-PDL1 therapy has been approved in first and second line Non-Small Cell Lung Cancer (NSCLC). This approval is restricted to patients whose tumors express PDL1 ≥ 50% for first line and ≥ 1% for second line thereby heralding a new era in immune-oncology and personalized medicine. The talk will focus on the development of a PDL1 IHC diagnostic test for Keytruda eligibility and cover aspects of selection of scoring guidelines in training sets and their application in Phase III trials.





ASA Princeton-Trenton Chapter