Welcome to the Bayesian Statistical Science Section

The Bayesian Statistical Science Section of the ASA provides a forum for statisticians and people who have interest in the Bayesian paradigm. The broad objectives of the Section are: to encourage research on theory and methods of statistical inference and decisionmaking associated with Bayes' theorem and to encourage the application and proper use of Bayesian procedures in the behavioral, biological, managerial, engineering, environmental, legal, medical, pharmaceutical, physical, and social sciences.



Current Affairs 

Upcoming Web-Based Lectures

Title: Overview, Hurdles, and Future Work in Adaptive Design
Presenter: Christopher Coffey, Department of Biostatistics, School of Public Health, University of Iowa
Date and Time: Wednesday, August 20, 2014, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Monday, August 18, at 12:00 p.m. Eastern time

Description:
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 webinar will first provide some clarification on the topic and describe some of the more commonly proposed adaptive designs. It will focus on some specific barriers that impede the use of adaptive designs in the current environment. Finally, there will be a discussion on future work that is needed to ensure that investigators can achieve the promised benefits of adaptive designs.




Title: Modeling and Simulation Approach to Optimize the Assessment of the Potential for QT Prolongation
Presenter: Daniel Weiner, SrVP & GM, Certara
Date and Time: Thursday, September 18, 2014, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Tuesday, September 16, at 12:00 p.m. Eastern time

Description:
Regulatory authorities require that all drugs be assessed for the potential for drug-induced QT interval prolongation, which is a biomarker for Torsades de Pointes, which can sometimes result in sudden death. Since 1988, there have been at least 14 drugs withdrawn from market as a result of QT prolongation (Stockbridge et al. Drug Safety 2013;36: 167-182). There are currently two Regulatory Requirements regarding this safety assessment: ICH E14 and S7B, which cover clinical and nonclinical evaluations, respectively.

The main topics of this webinar are
1) Review of the E14 Guidance and the concept of a Thorough QT (TQT) Study, including a discussion of how such studies should be analyzed
2) Discussion of what data to collect, on an ongoing basis, to assess the potential for QT prolongation
3) Discuss methods to determine if there is an emerging signal regarding the relationship between drug exposure and QT prolongation, and how to use that information for dose selection in the TQT and other subsequent clinical trials

Concepts will be illustrated with case studies.

 



*** More information and registration at the webinar page.





 

From the SBSS Mixer at JSM 2013