menu
event

2016 Trends and Innovations in Clinical Trial Statistics

Co-organized by Quintiles Advisory Services Analytics, Department of Statistics at North Carolina State University and ASA North Carolina Chapter

Sheraton Imperial Hotel and Convention Center, Durham, North Carolina

May 01, 2016  -  May 04, 2016

Register Save to Calendar

Thank you for attending the 2nd Trends and Innovations in Clinical Trial Statistics conference, a forum where presenters and panelists discussed the current trends, innovation, and needs in clinical trial statistics.

The conference is aimed at a broad audience of statisticians and scientists involved in the design and analysis of clinical trials. It featured presentations from regulatory agencies, biopharmaceutical industry, and academia.

Conference Keynote Speakers include:

Robert M. Califf, MD, Commissioner of Food and Drugs, US Food and Drug Administration: “Regulatory Trials and Other Trials: A False Dichotomy?"
David Madigan, PhD, Executive Vice-President for Arts and Sciences, Dean of the Faculty, Professor of Statistics, Columbia University: “Large Observational Healthcare Studies: Challenges, Pitfalls, and Future Directions”
Stephen J. Ruberg, PhD, Distinguished Research Fellow, Scientific Leader, Advanced Analytics, Eli Lilly: “Making What’s Advanced Today Routine Tomorrow”

Conference Program

Click here to view the entire conference program. Or scroll below to view and download individual presentations. Presentation slides will be available on the website for the next 3 months.

NOTICE: The Presentation Slides (“Content”) from the TICTS Conference are provided here for educational, research and scholarship purposes.  The respective authors of the Content, and not Quintiles, are solely responsible for the Content and any opinions and work product in the Content.  Quintiles has neither modified, monitored, curated, participated in, nor edited any of the Content.  The fact that the Content is shown here does not mean that Quintiles endorses or supports, or does not endorse or not support, any Content, including opinions, recommendations and/or advice therein.  Quintiles expressly disclaims any and all liability in connection with the Content.  The authors have granted permission for the presentation to be posted on this site, but this should not be construed to be permission for further copying.  Should any questions arise concerning the Content, the respective authors should be contacted.

DAY ONE: Monday May 2
  • Opening Remarks Marie Davidian, William Neal Reynolds Professor, Department of Statistics, NCSU Olga Marchenko, Vice President, Head of Advisory Services Analytics, Quintiles Download
  • Conference Keynote Address Robert M. Califf, Commissioner of Food and Drugs, US Food and Drug Administration: “Regulatory Trials and Other Trials: A False Dichotomy?" Download
Session 1a: Statistical Challenges and Opportunities for Innovation
Presenters:
  • Dionne Price, Director, Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, CDER, FDA: “The Role of Statistical Innovation in Antibacterial Drug Development” Download
  • Thomas Gwise, Deputy Director, Division of Biometrics V, CDER, FDA: “Statistical Approaches for Biosimilarity Evaluation” Download
  • John Scott, Deputy Director, Division of Biostatistics, Center for Biologics Evaluation and Research, FDA: “Trial Designs for Evaluating Biological Products for the 2014-15 Ebola Outbreak” Download
  • Lilly Yue, Deputy Director, Division of Biostatistics, Center for Devices and Radiological Health, FDA: “Statistical Innovations in the Medical Device World” Download
  • Discussant: Lisa LaVange, Director of the Office of Biostatistics in the Office of Translational Science, CDER, FDA Download
Session 1b: Statistical Challenges and Opportunities for Innovation (Cont.) Panel Download


Session 2: Novel Trial Designs and Their Implementation
Presenters:
  • Martin Posch, Professor, Center for Medical Statistics, Informatics and Complex Systems Medical University of Vienna: “Optimizing Confirmatory Clinical Trial Designs for Targeted Therapies” Download
  • Anastasia Ivanova, Associate Professor, Department of Biostatistics, University of North Carolina, Chapel Hill: “Enrichment by response: Sequential Parallel Comparison Design (SPCD), overview and case studies” Download
  • Stephen Senn, Professor, Luxembourg Institute of Health: “A little bit me, a little bit you: N of 1 trials, random effects and shrinkage estimators” Download
Session 3: Bayesian Applications
Presenters:
  • Nicky Best, Head of Statistical Innovation Group, Quantitative Sciences, GSK: “Bayesian mixture priors for clinical trial design and analysis” Download
  • Joseph Ibrahim, Alumni Distinguished Professor, Department of Biostatistics, University of North Carolina, Chapel Hill: “Bayesian Design of Superiority Clinical Trials for Recurrent Events Data with Applications to Bleeding and Transfusion Events in Myelodyplastic Syndrome” Download
Session 4: Quantitative Evaluation of Safety in Drug
Presenters:
  • Qi Jiang, Executive Director, Global Biostatistical Science, Amgen: “Statistical Evaluation of Drug Safety Data” Download
  • Frank Rockhold, Professor of Biostatistics and Bioinformatics, Duke University School of Medicine: “The Role of Quantitative Science in Medicine Safety and Pharmacovigilance” Download
  • Mark Levenson, Acting Director, Division of Biometrics VII, CDER, FDA: “Recent Efforts in Quantitative Drug Safety Evaluation at FDA/CDER” Download
  • Panel: Qi Jiang (Amgen), Frank Rockhold (Duke), Mark Levenson (CDER, FDA), Olga Marchenko (Quintiles), John Scott (CBER, FDA) Download
DAY TWO: Tuesday May 3
Keynote Address: David Madigan, Executive Vice-President for Arts and Sciences, Dean of the Faculty, Professor of Statistics, Columbia University: “Large Observational Healthcare Studies: Challenges, Pitfalls, and Future Directions” Download

Session 5: Big Data and Analytics
Presenters:
  • Doug Faries, Research Fellow, Global Statistical Sciences – Real World Analytics, Eli Lilly: “Unmeasured Confounding: Challenges and Solutions for Real World Analytics” Download
  • Ilya Lipkovich, Principal Scientific Advisor, Quantitative Decision Strategy and Analytics, Advisory Services, Quintiles: ”Evaluation of different strategies for estimating treatment effect in observational studies” Download
  • John Doyle, Senior Vice President, Advisory Services, Quintiles: “RWE and RBA: Real-world Evidence Potentiating Risk-Benefit Analysis” Download
Session 6: Clinical Trial Optimization & Visualization
Presenters:
  • Erik Pulkstenis, Vice President, Clinical Biostatistics and Data Management, MedImmune: “Quantitative Decision Making in Phase 2 trials” Download
  • Gautier Paux, Servier: “Clinical trial optimization approaches to Phase III trials with multiple objectives” Download
  • Zachary Skrivanek, Principal Research Scientist, Advanced Analytics, Eli Lilly: “Visual Analytics for Clinical Development” Download
Session 7: Use of Modeling and Simulations to Improve Decision Making
Presenters:
  • Jonathan French, Principal Scientist II and Director of Innovation, Metrum Research Group:” Estimation of exposure-response relationships in the presence of confounding”. Download
  • Brenda Gaydos, Research Fellow, Head of Clinical Trial Optimization, Eli Lilly: “Learn BEFORE doing: Utilizing modeling and simulation to understand the implications of a decision before making it” Download
  • Michael O’Kelly, Principal Scientific Advisor, Advisory Services Analytics, Quintiles: ”Best practice in modelling and simulation: European initiatives” Download
Session 8: Pharmacokinetic/pharmacodynamics focused Modeling and Simulations
Presenters:
  • Nitin Mehrotra, Team Leader, Division of Pharmacometrics, Office of Clinical Pharmacology, OTS, CDER, FDA: “Role of Pharmacokinetic/Pharmacodynamic modeling in regulatory decisions: case studies” Download
  • Matt Hutmacher, Ann Arbor Pharmacometrics Group: “The Probability of a Correct Decision: its Utility in Trial Design for Dose Selection when Prior Information is Limited” Download
DAY THREE: Wednesday May 4
Keynote Address: Stephen J. Ruberg, Distinguished Research Fellow, Scientific Leader, Advanced Analytics, Eli Lilly: “Making What’s Advanced Today Routine Tomorrow” Download

Session 9: Clinical Trials in Small Population
Presenters:
  • Jeffrey Schwartz, Senior Director, Global Innovative Pharma Business, Rare Disease/Renal/Other (RDRO) Statistics, Pfizer, Inc.: “Nature and Extent of Evidence for Decision: Challenges in Rare Disease Research” Download
  • Kit C.B. Roes, Professor of Biostatistics of Clinical Trials and Quality of Care, Director Quality and Patient Safety, University Medical Center Utrecht, The Netherlands: “Designs and Decisions When the Sample Size is Truly Limited” Download
  • Robert Beckman, Georgetown University Medical Center: “Design Concept for a Confirmatory Basket Trial” Download
  • Cong Chen, Director, Late Development Statistics – Oncology, Merck research Labs, Merck & Co.: “Theory and Applications of Benefit-Cost Ratio” Download
Session 10: Raising New Generation of Statisticians
Presenters:
  • Lisa LaVange, Director of the Office of Biostatistics in the Office of Translational Science, CDER, FDA: “Addressing the Critical Need for Statisticians at FDA“ Download
  • Marie Davidian, William Neal Reynolds Professor, Department of Statistics, NCSU: "Engaging and Inspiring the Next Generation" Download
  • Lance Waller, Rollins Professor and Chair, Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University: “Thoughts on Recruiting a Generation You Don't Belong To” Download
Keynote Speakers

Robert M. Califf, MD

Commissioner of Food and Drugs, US Food and Drug Administration

David Madigan, PhD

Executive Vice President and Dean of Faculty of Arts and Sciences and Professor of Statistics, Columbia University

Stephen J. Ruberg, PhD

Distinguished Research Fellow, Scientific Leader, Advanced Analytics, Eli Lilly