The Trends and Innovations in Clinical Trial Statistics conference was held at the Sheraton Imperial Hotel and Convention Center (Durham, North Carolina) on April 21-23, 2014. The conference was organized by the Quintiles Center for Statistics in Drug Development and the Department of Statistics at North Carolina State University.
Conference chairs
The conference was co-chaired by Dr. Olga Marchenko (Quintiles), Dr. Alex Dmitrienko (Quintiles) and Prof. Marie Davidian (North Carolina State).
The conference chairs would like to thank the organizing committee, session chairs, presenters and participants for the great feedback. The next conference will be held in May 2016.
Conference organizing committee
The organizing committee included Olga Marchenko (Quintiles), Alex Dmitrienko (Quintiles), Marie Davidian (North Carolina State), José Pinheiro (Janssen), Matilde Sanchez (Arena Pharmaceuticals), Nevine Zariffa (AstraZeneca), Frank Shen (Abbvie), Stephen Ruberg (Lilly), Martin Posch (Medical University of Vienna), Gary Koch (University of North Carolina).
Keynote speakers
Keynote presentations were given by
- Dr. Dennis Gillings (Chairman, Quintiles, Inc).
- Dr. Lisa LaVange (Food and Drug Administration).
- Prof. Anastasios (Butch) Tsiatis (Department of Statistics, North Carolina State University).
Program
The conference was aimed at a broad audience of statisticians and scientists involved in the design and analysis of clinical trials. It featured presentations by biostatistical experts from regulatory agencies, biopharmaceutical industry and academia on key topics in clinical trial statistics, including adaptive clinical trials, multiplicity issues, tailored therapeutics, biomarker discovery and subgroup identification, treatment and prevention of missing data, analysis of safety data, design and analysis of dose-ranging studies and statistical methods used in oncology and neuroscience clinical trials.
For more information on the conference, download the conference program.
Short courses
Pre-conference half-day courses were offered on April 21.
Presentation slides
Session 1: New Trends in Clinical Trials
Névine Zariffa (AstraZeneca). “The future ain’t what it used to be” – Yogi Berra. Have statisticians received the memo?
Session 2: Statistical Advances in Personalized Medicine and Tailored Therapeutics
Robert A. Beckman (Daiichi Sankyo Pharmaceutical Development). Integrating Predictive Biomarkers and Classifiers into Oncology Clinical Development Programs. Download the slides.
Marie Davidian (North Carolina State University). Implementing Personalized Medicine: Estimating Optimal Dynamic Treatment Regimes. Download the slides.
Session 3: Multiplicity Issues in Clinical Trials
Alex Dmitrienko (Quintiles). Analysis of clinical trials with multiple objectives. Download the slides.
Gary G. Koch (University of North Carolina at Chapel Hill). Overview of strategies to address multiplicity for primary and key secondary assessments in confirmatory clinical trials. Download the slides.
Session 4: Adaptive Designs in Drug Development
Brenda Gaydos (Eli Lilly). An approach to develop an adaptive design and illustrate advantages over traditional approaches utilizing modeling and simulation. Download the slides.
Estelle Russek-Cohen (FDA). Adaptive Designs: CBER Statistical Experience.
Session 5: Data Mining and Subgroup Identification
Ilya Lipkovich (Quintiles). Data mining methods for subgroup identification. Download the slides.
S. Stanley Young (NISS). Subgroup analysis in large medical data sets.
Session 6: Missing Data
Craig Mallinckrodt (Eli Lilly). Trends and Innovations in Missing Data Sensitivity Analyses. Download the slides.
Michael O’Kelly (Quintiles). Missing data in clinical trials: developments in practice. Download the slides.
Session 7: Statistical Methods in Dose-Ranging Studies
Sergei Leonov (AstraZeneca). Optimal model-based designs in dose ranging. Download the slides.
José Pinheiro (Janssen). Generalizing the MCPMod methodology beyond normal, independent data. Download the slides.
Session 8: Analysis of Safety Data
Aloka G. Chakravarty (FDA). Quantitative Safety Evaluation at CDER: An Overview. Download the slides.
Session 9: Statistical Applications in Oncology Clinical Trials
Keaven M. Anderson (Merck). Targeted therapy drug development issues in a pharmaceutical company setting.Download the slides.
Anastasia Ivanova (University of North Carolina at Chapel Hill). Recent developments in trial design in oncology. Download the slides.
Session 10: Statistical Applications in Neuroscience Clinical Trials
Sonia Davis (University of North Carolina at Chapel Hill). Some design approaches to address missing data in neuroscience clinical trials. Download the slides.
José Pinheiro (Janssen). Safety Monitoring and Evaluation in Late Phase Clinical Development. Download the slides.
Poster session
The following poster presenters won the poster competition:
- First place: Tian Chen (Department of Statistics, North Carolina State University).
- Second place: Shesh N. Rai (JG Brown Cancer Center, University of Louisville).
- Third place: Carl DiCasoli (Bayer).