The Duke Industry Statistics Symposium 2019

Recent Updates

Apr. 16, 2019

Creating Collaborations and Connections with Academic, Government and Industry Statisticians

More than 250 participants from across the country attended the 6th Duke-Industry Statistics Symposium (DISS 2019) “Innovative Design and Analysis for Drug and Device Developments.

Dr. Warren Kibbe, introduced the first speaker, Duke Vice Provost for Research, Dr. Larry Carin, who provided some framing for biostatistics and machine learning. The first keynote was given by Dr. John Scott, PhD, Director, Division of Biostatistics, Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. Dr. Scott’s address, “Informing Decision Making Through Innovative Trial Designs and Analyses,” centered on efforts at the FDA to enable and validate the next generation of clinical trials.  Any statistician who’s spent time working in pharmaceutical product development has experienced that nagging thought while pondering their best-effort clinical trial design: will it be good enough for the FDA? The question seems especially relevant given the current state of the field which is moving now, more aggressively than ever, away from the line-in-the-sand approach to statistical inference. But as practitioners we wonder…have the powers-that-be even read that issue of the journal?! Thanks to John Scott, we know they have! It was refreshing to hear Dr. Scott’s discussion of the FDA’s efforts to understand complex and innovative trial designs, to hear his personal thoughts on the issues, and to learn about FDA’s new guidance on adaptive designs for drugs and biologics. 

The first day of the Symposium was devoted to three half day short courses with topics: Randomized Phase II Trials, Bioequivalence-and Biosimilarity and Adaptive Bayesian and Complex Clinical Trials: What, How and Why and one full day tutorial on Bayesian Methods for Design and Analysis for Clinical Trials.  Fifteen parallel sessions were held on Thursday and Friday. The second keynote was given on Friday morning by Dr. Scott Berry, President and a Senior Statistical Scientist of Berry, Consultants, LLC on “Innovating the Clinical Trial: Adaptive and Platform.”  Scott Berry’s presentation artfully traced the timeline from where clinical trials started to what they’ve become today, and showed a realistic vision for where they are headed in the future. Dr. Berry’s vision was abundantly clear in the recent examples he used to illustrate the application of innovative trial designs that addressed complex study objectives. Such efforts would’ve seemed like science fiction to even the most experienced clinical-trialist just a few short years ago. This is truly an exciting time to be working on clinical trials.

Wenda Tu, a doctoral student  from the University of Iowa won the prize for best poster for “Utilizing Concurrent and Historical Controls/Information in Small-Sized Platform Clinical Trials.” The poster session highlighted the great research and activities of the DISS 2019 participants and presenters. 

This is the 6th symposium organized by the Department of Biostatistics and Bioinformatics, Duke University School of Medicine and is led by faculty member  Xiaofei Wang, PhD.  It is co-sponsored by Amgen, Boehringer-Ingelheim, ICSA, IQVIA,  Janssen, NC-ASA Chapter, PAREXEL, PPD, and Quintiles.  This symposium was established 7 years ago to discuss challenging issues and recent advances related to the clinical development of drugs, biologics and devices and to promote research and collaboration among statisticians from industry, academia and regulatory agencies.

Photo: Wenda Tu discusses her winning poster with Dr. Marlina Nasution, of PAREXEL