Education > Continuing Education

Web-Based Lectures

Previously recorded webinars are available through the LearnSTAT OnDemand program.

Current Webinar Offerings:


September 18, 2014 Modeling and Simulation Approach to Optimize the Assessment of the Potential for QT Prolongation
October 21, 2014 Coordinating Collection, Analysis and Submission of Clinical Trials Data with Metadata Standards - Focus on Tabulations Deliverables (Part 1 of 2)
October 22, 2014 Design and Analysis of Biomarkers Studies for Risk Prediction
October 29, 2014 Bayesian Methods in Pharmaceutical Development
November 4, 2014 Coordinating Collection, Analysis and Submission of Clinical Trials Data with Metadata Standards - Focus on Analysis Deliverables (Part 2 of 2)
November 18, 2014 Bayesian Combination Dose Finding: Concepts and Applications




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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 Since 1988, there have been at least 14 drugs withdrawn from market as a result of QT prolongation (Stockbridge et al.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.

Registration Fees:
Biopharmaceutical Section Members: $44
ASA Members: $59
Nonmembers: $74

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).

Registration is Closed

Access Information
Registered persons will be sent an email the afternoon of Tuesday, September 16, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




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Title: Coordinating Collection, Analysis and Submission of Clinical Trials Data with Metadata Standards - Focus on Tabulations Deliverables (Part 1 of 2)
Presenter: Steve Kirby, Mario Widel and Luke Reinbolt
Date and Time: Tuesday, October 21, 2014, 12 p.m. - 1:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts

Registration Deadline: Friday, October 17, at 12:00 p.m. Eastern time

Description:
Starting with a diagram that links key submission deliverables and associated metadata, the authors will share how companies can plan to have key content needed to support study planning and generation of CDISC data, TFLs and associated documentation available as metadata and will discuss how that metadata can support operational efficiency and a transparent, traceable path from study planning to regulatory submission.

For each deliverable, the authors will explore the use case for a metadata driven approach, share a specific, concrete process example and investigate how the content is related to other aspects of the clinical trials process.

Part 1 will focus on tabulations deliverables and associated metadata. Analysis metadata will be included as needed to ensure that the tabulations content will support analysis objectives and study endpoints. Key content areas will be: Protocol/SAP metadata and SDTM Trial Design domains; and SDTM metadata, SDTM mapping code and associated submission documentation (blankcrf.pdf, define.xml, Reviewer's Guide).

Registration Fees:
Member of the Section for Statistical Programmers and Analysts: $40
ASA Member: $65
Nonmember: $85

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).

Register



Access Information
Registered persons will be sent an email the afternoon of Friday, October 17, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




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Title: Design and Analysis of Biomarkers Studies for Risk Prediction
Presenter: Tianxi Cai, Department of Biostatistics, Harvard School of Public Health
Date and Time: Wednesday, October 22, 2014, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Monday, October 20, at 12:00 p.m. Eastern time

Description:
An accurate and individualized outcome prediction promises to dramatically change clinical decision making in many branches of medicine, for example in early diagnosis of cancer and in selecting patient-specific treatments. But translating the promise into reality is not easy. Clinical evaluations, while remaining an essential basis for risk assessment, may not be sufficient for complex diseases. Improved prediction may be achieved by combining information from multiple markers based on emerging new technology such as gene expression profiling, protein mass spectrometry and proton emission tomography. Most marker tests are imperfect, and incorporate test results can have enormous consequences in both financial and human terms. Prior to incorporating a biomarker into standard clinical care, rigorous evaluation is required. Designing an rigorous study that efficiently uses available biologic specimens is critical. Compared to classical statistical methods for evaluating medical diagnostic test, there is relatively little literature devoted to statistical methods for marker development carried out in a prospective cohort study with censored failure time outcome. This webinar will introduce recent statistical development for constructing and evaluating risk prediction model (markers) with censored data. While providing some mathematical details, we will emphasize the concepts, methods and their real world applications with the aim of both offering an overview of the rapid developing area of risk prediction and biomarker evaluation; and discussions on efficient design of biomarker and risk prediction studies.

Registration Fees:
Biopharmaceutical Section Members: $44
ASA Members: $59
Nonmembers: $74

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).

Register



Access Information
Registered persons will be sent an email the afternoon of Monday, October 20, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




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Title: Bayesian Methods in Pharmaceutical Development
Presenter: Mani Lakshminarayanan, Pfizer, Inc and Karen Price, Eli Lilly and Company
Date and Time: Wednesday, October 29, 12:00 p.m. - 2:00 p.m. Eastern Time
Sponsor: Section on Bayesian Statistical Science and the International Society for Bayesian Analysis

Registration Deadline: Monday, October 27, at 12:00 p.m. Eastern time

Description:
In this data-centric computer age, especially when the scientific community is baffled with how to deal with "Big Data" that has a potential to transform business, health care, scientific discovery and public policy in a significant manner, Bayesian methods are making inroads into the scientific community with rapid growth and acceptance. This upsurge of interest is also seen in various scientific areas, technology, social sciences, management and commerce, where the members have started recognizing the benefits and flexibility of Bayesian methods in supporting their scientific quest. In the pharmaceutical research, both NICE (National Institute of Clinical Excellence) and the Medical Devices Division of the Food and Drug Administration have already signaled their acceptance of Bayesian methods in their submissions and have taken big steps in providing relevant guidance on this topic. Various other organizations have indicated support of increasing the appropriate use of Bayesian methods, such as the Drug Information Association (DIA) which houses the Bayesian Scientific Working Group (DIA BSWG). The DIA BSWG has a vision to ensure that Bayesian methods are well-understood and broadly utilized for design, analysis and throughout the medical product development process and to improve industrial, regulatory and economic decision making.

In this webinar, our primary objective is to discuss some of the current topics in which Bayesian methods provide a natural platform to quantify and address directly key questions and issues that arise at all stages of pharmaceutical product development. Our discussion will fully highlight and elaborate on some of the areas that the DIA BSWG has been working on since 2011 including safety signal detection, network meta-analysis and non-inferiority trials. In addition, we will discuss topics such as use of probability of success and prior elicitation. Such topics are relevant in addressing a common issue that arises in projects involving clinical trial development, that is, how to integrate findings from early phase trials explicitly and other compounds' trials data in order to objectively provide specific quantitative guidance for the design of later trials. Our primary intention is to focus on discussing methodology and applications with examples that are prevalent currently in the pharmaceutical community.

Registration Fees:
SBSS Members: $60
ISBA Members: $60
ASA Members: $75
Nonmembers: $95

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).

Register



Access Information
Registered persons will be sent an email the afternoon of October 27, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




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Title: Coordinating Collection, Analysis and Submission of Clinical Trials Data with Metadata Standards - Focus on Analysis Deliverables (Part 2 of 2)
Presenter: Steve Kirby, Mario Widel and Luke Reinbolt
Date and Time: Tuesday, November 4, 2014, 12 p.m. - 1:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts

Registration Deadline: Friday, October 31, at 12:00 p.m. Eastern time

Description:
Starting with a diagram that links key submission deliverables and associated metadata, the authors will share how companies can plan to have key content needed to support study planning and generation of CDISC data, TFLs and associated documentation available as metadata and will discuss how that metadata can support operational efficiency and a transparent, traceable path from study planning to regulatory submission.

For each deliverable, the authors will explore the use case for a metadata driven approach, share a specific, concrete process example and investigate how the content is related to other aspects of the clinical trials process.

Part 2 will focus on analysis deliverables and associated metadata. As what actually happens in a study (or related studies) impacts analysis, this analysis content is in some cases impacted by tabulations content presented in Part 1. Key content areas will be: ADaM metadata and ADaM mapping code; TFL metadata and TFL code; and associated submission documentation (define.xml, Reviewer's Guide).

Registration Fees:
Member of the Section for Statistical Programmers and Analysts: $40
ASA Member: $65
Nonmember: $85

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).

Register



Access Information
Registered persons will be sent an email the afternoon of Friday, October 31, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




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Title: Bayesian Combination Dose Finding: Concepts and Applications
Presenter: Simon Wandel (Cogitars)
Date and Time: Tuesday, November 18, 2014, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Friday, November 14, at 12:00 p.m. Eastern time

Description:
Particular interest in Bayesian model-based dose finding has been observed in recent years. Multiple publications of successful single-agent phase I Oncology studies undermine the related paradigm shift which happened at some Pharmaceutical companies already and is ongoing in others. However, nowadays single agent dose finding is not the only goal in early development; rather, combination dose finding starts to play an important role which poses new challenges to clinical teams and statisticians.

In this webinar, an introduction to the statistical concept of Bayesian model-based dose finding with a particular emphasis on the combination setting will be provided. Based on practical experience, a special section will be devoted to the selection of the starting dose combination where both, statistical modeling and clinical considerations play an important role. Real case studies will be used to illustrate concepts and methods along with potential pitfalls which should be avoided. Finally, based on a literature search and on personnel communication, an overview of the current trends and adaption in the United States and in Europe will be provided.

Registration Fees:
Biopharmaceutical Section Members: $44
ASA Members: $59
Nonmembers: $74

Each registration is allowed one web connection and one audio connection. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).

Register



Access Information
Registered persons will be sent an email the afternoon of Friday, November 14, with the access information to join the webinar and the link to download and print a copy of the presentation slides.