February 10, 2015 | 1:30 - 5:00 PM
Tutorial 1: Bayesian Methods for Drug Safety Evaluation and Signal Detection
Tutorial 2: Use of Historical Data in Clinical Trials
As the complexity of pharmaceutical development escalates, researchers must leverage increasingly sophisticated statistical tools for design and analysis, including broader use of Bayesian methods and adaptive designs. There has been an upturn in interest and application of adaptive design and Bayesian statistics, in part due to their inclusion within the FDA's Critical Path Opportunities List.
While these methods have already contributed in many ways to reductions in risk, time, and cost of medical product development, and to overall improvements in decision making; for many drug developers, device, and diagnostic manufactures adaptive design and Bayesian statistics are still buzz-words. Per a recent survey conducted by DIA’s Bayesian Scientific Working Group, education continues to be a significant gap in a broader appropriate uptake of Bayesian methods, including their use in adaptive designs. In order to improve the implementation of adaptive design and Bayesian statistics, we must demystify the practice and application of these proven methodologies.
February 2015 marks the 5th anniversary of the publication of the FDA’s draft guidance on adaptive clinical trials and the final guidance of the use of Bayesian statistics in medical device clinical trials. Join us to celebrate these important milestones for clinical trials as well as to engage FDA representatives in discussions regarding the progress of both adaptive design and Bayesian statistics and to speculate the future for this science.
This conference will present the latest advancements in the application of adaptive design and Bayesian statistics to include critical aspects such as a better understanding of methodologies, identifying opportunities for when to apply them, analysis, and improved decision making. Presentations will be given from statistical, clinical, and regulatory viewpoints to provide a more complete picture of appropriate adaptive design and Bayesian statistics implementation.
Sessions will consist of joint and independent adaptive design and Bayesian statistic plenaries as well as concurrent breakout sessions for each class of methods. Case studies will be presented throughout the conference to encourage discussions and debates regarding the use of Bayesian and adaptive design methods within modern medical product development from presenters across industry, regulatory, and academia.
This program has been developed in collaboration with the DIA Adaptive Design Scientific Working Group and the Bayesian Statistics Scientific Working Group.
This program is being marketed in collaboration with the International Society for Bayesian Analysis (ISBA).
- 5th anniversary of FDA’s final guidance of the use of Bayesian statistics
- 5th anniversary of FDA’s draft guidance on adaptive clinical trials in medical device clinical trials
Who should attend?
Professionals from industry, academia, and government involved in medical product development from learning to confirmatory phases or in new drug/device application review:
- R&D Design-makers
- Comparative Effectiveness
- Evidence Based Medicine
- Regulatory Scientists
- Safety and Pharmacovigilance
- Post Marketing
At the conclusion of this meeting, participants should be able to:
- Apply concepts related to adaptive design and Bayesian methods
- Identify opportunities for improving pharmaceutical, device, and diagnostic product development by application of adaptive design and/or Bayesian statistics
- Assess whether the application of adaptive design and/or Bayesian methods would improve metrics such as cost, time of development, and probability of success, compared to the application of more traditional method
Zoran Antonijevic, MSc • Senior Director Cytel Consulting, United States
Karen Lynn Price, PhD, MA • Research Advisor Eli Lilly and Company, United States
Kenneth A. Getz, MBA • Chairman, CISCRP; Director of Sponsored Research Tufts Center for the Study of Drug Development, United States
Roger J. Lewis, MD, PhD • Professor of Medicine, Department of Emergency Medicine Harbor UCLA Medical Center, United States
David Ohlssen, PhD • Senior Expert Methodologist Novartis Pharmaceuticals Corporation, United States
Yili Pritchett, PhD • Senior Director, Global Development Astellas Pharma Inc., United States
M. Scott Harris, MD, MS, FACP • Principal Lyric Pharmaceuticals, United States
Estelle Russek-Cohen, PhD • Director, Division of Biostatistics, OBE, CBER FDA, United States
John W. Seaman, PhD • Professor of Statistics Baylor University, United States
Laura Thompson, PhD • Mathematical Statistician, CDRH FDA , United States
Ram Tiwari, PhD • Associate Director, Office of Biostatistics, OTS, CDER FDA, United States
Sue-Jane Wang, PhD, MA, MS • Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER FDA, United States
Amy Xia, PhD • Executive Director, Biostatistics Amgen, Inc., United States
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