Education > Continuing Education
Web-Based Lectures
Previously recorded webinars are available through the LearnSTAT OnDemand program.
Current Webinar Offerings:
| May 14, 2013 | Subgroup Analysis in Clinical Trials |
| May 22, 2013 | The Cautious Use of Bayesian Methods in Reliability Data Analyses |
| June 12, 2013 | An Introduction to Joint Models for Longitudinal and Time-to-Event Data |
| September 10, 2013 | Helping Data Work Together: Harmonizing CRF Design with CDISC SDTM Standards |
| September 12, 2013 | DSMBs/DMCs |
| September 24, 2013 | Preparing to Share CDISC SDTM Data: A Practical Look at How to Conduct and Document Review of SDTM Data and Documentation |
| October 23, 2013 | Detecting Safety Signals Among Adverse Events in Clinical Trials |
| December 4, 2013 | Signal Detection Methods for Large Drug Safety Reporting Databases |
Title: Mixed Models for Longitudinal Categorical Outcomes
Presenter: Donald Hedeker, University of Illinois at Chicago
Date and Time: Tuesday, April 30, 2013, 12:00 p.m. - 1:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts
Registration Deadline: Friday, April 26, at 12:00 p.m. Eastern time
Description:
This workshop will focus on analysis of longitudinal data using mixed models. Because dichotomous, ordinal and nominal outcomes are common in many areas of research, this Webinar will focus on the mixed logistic regression model and generalizations of it. Specifically, the following models will be described: mixed logistic regression for dichotomous outcomes, mixed logistic regression for nominal outcomes, and mixed proportional odds and non-proportional odds models for ordinal outcomes. The latter models are useful because the proportional odds assumption of equal covariate effects across the cumulative logits of the model is often unreasonable. Use of the program SuperMix for these models will be described and illustrated.
Registrants should be familiar with logistic regression and mixed models for continuous outcomes.
A free trial version or free student version of SuperMix is available at http://www.ssicentral.com/supermix/downloads.html. Registrants can download the software and try it out before the Webinar if they wish. The analyses that will be discussed could also be done with SAS.
About the Presenter
Dr. Hedeker has co-authored a book, Longitudinal Data Analysis (2006) Wiley, on the topic and has also co-authored several freeware programs for mixed model analysis (MIXOR, MIXREG). Additionally, he is one of the authors of the SuperMix program.
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).
Registration is Closed
Access Information
Registered persons will be sent an email the afternoon of Friday, April 26, with the access information to join the webinar and the link to download and print a copy of the
presentation slides.
Title: Subgroup Analysis in Clinical Trials
Presenter: Alex Dmitrienko and Ilya Lipkovich (Center for Statistics in Drug Development, Quintiles)
Date and Time: Tuesday, May 14, 2013, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section
Introduction Slides
Registration Deadline: Friday, May 10, at 12:00 p.m. Eastern time
Description:
This talk focuses on a broad class of statistical problems arising in subgroup analysis. It will begin with a discussion of issues related to confirmatory subgroup analysis, i.e., analysis of pre-specified subgroups in the context of confirmatory Phase III clinical trials. This includes a summary of general principles of confirmatory subgroup analysis (interpretation of findings in several patient populations, influence and interaction conditions). In addition, a review and comparison of multiplicity adjustment methods used in confirmatory subgroup analysis will be provided.
The second part of the talk deals with exploratory subgroup analysis, i.e., subgroup search/biomarker discovery methods that can be applied both in early and late-phase clinical trials. The discussion of exploratory subgroup analysis methods begins with a review of common approaches to subgroup identification in the context of personalized medicine and then focuses on the SIDES method and its extensions. SIDES is based on recursive partitioning and can be used in prospective and retrospective subgroup analysis. Key elements of SIDES will be discussed, including (1) generation of multiple promising subgroups based on different splitting criteria, (2) specifying values of complexity parameters, (3) evaluation of variable importance, and (4) addressing Type I error rate inflation using a resampling-based method.
Case studies will be used to illustrate the principles and statistical methods introduced in this course. A software tool for exploratory subgroup analysis will be presented (SIDESxl package developed by the authors).
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 Friday, May 10, with the access information to join the webinar and the link to download and print a copy of the presentation slides.
Title: The Cautious Use of Bayesian Methods in Reliability Data Analyses
Presenter: William Meeker, Iowa State University
Date and Time: Wednesday, May 22, 2013, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Section on Physical and Engineering Sciences and the Quality and Productivity Section
Registration Deadline: Monday, May 20, at 12:00 p.m. Eastern time
Description:
The development of theory and application of Monte Carlo Markov Chain (MCMC) methods, vast improvements in computational capabilities, and emerging software tools have made it possible for the wide-spread use of Bayesian methods in reliability applications. Bayesian methods, however, remain controversial in reliability (and other applications) because of the concern about where the needed prior distributions should come from. There are, however, many applications where engineers have solid prior information on certain aspects of their reliability problems based on physics of failure or previous experience with the same failure mechanism (e.g., imprecise knowledge about the activation energy in a temperature-accelerated life test or about the Weibull shape parameter in analysis of fatigue failure data). In such applications, the use of Bayesian methods offers an appropriate compromise between assuming that such quantities are known and assuming that nothing is known.
This webinar will focus on the important conceptual ideas behind the use of Bayesian methods, on practical concerns for implementation and use of Bayesian methods, and on examples. Topics to be discussed include "Whose prior information should we use" and the kinds of information that can and should be elicited from experts as well as a gentle introduction to modern MCMC methods. The methods will be illustrated with examples that include the analysis of accelerated life test data (an electronic device), accelerated repeated measures degradation test data (LEDs), and accelerated destructive degradation data (an adhesive bond).
Registration Fees:
Members of Q&P: $75
Members of SPES: $75
Members of SSC-BISS: $75
ASA Members: $90
Nonmembers: $105
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 Monday, May 20, with the access information to join the webinar and the link to download and print a copy of the presentation slides.
Title: An Introduction to Joint Models for Longitudinal and Time-to-Event Data
Presenter: Dimitris Rizopoulos, Department of Biostatistics, Erasmus University Rotterdam, Netherlands
Date and Time: Wednesday, June 12, 2013, 10:00 a.m. - 12:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section
Registration Deadline: Monday, June 10, at 12:00 p.m. Eastern time
Description:
In recent years there has been an increasing interest in the class of joint models for longitudinal and time-to-event data. These models constitute an attractive paradigm for the
analysis of follow-up data that is mainly applicable in two settings: First, when focus is on a survival outcome and we wish to account for the effect of endogenous time-dependents
covariates measured with error (e.g., biomarkers), and second, when focus is on the longitudinal outcome and we wish to correct for nonrandom dropout. This Webinar is aimed for
applied researchers and graduate students and will provide a short introduction of this modeling framework. In particular, we will explain when these models should be used in
practice, which are the key assumptions behind them, and how they can be utilized to extract relevant information from the data.
Emphasis will be given on application and the use of the R package JM.
This Webinar assumes knowledge of basic statistical concepts, such as standard statistical inference using maximum likelihood, and regression models. In addition, basic knowledge
of mixed effects and Cox proportional hazards models would be beneficial but is not required.
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).
Access Information
Registered persons will be sent an email the afternoon of Monday, June 10, with the access information to join the webinar and the link to download and print a copy of the
presentation slides.
Title: Helping Data Work Together: Harmonizing CRF Design with CDISC SDTM Standards
Presenter: Steve Kirby, Erica Greer, and Mario Widel
Date and Time: Tuesday, September 10, 2013, 12:00 p.m. - 1:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts
Registration Deadline: Friday, September 6, at 12:00 p.m. Eastern time
Description:
The FDA strongly encourages sponsors to provide study tabulations data in CDISC SDTM format. Planning to provide SDTM data as you translate the protocol into electronic CRF forms and associated output data sets saves money and avoids stress by providing a clear path from collection data to submission domains. Creating a clear path from collection data to submission domains is driven by communication and collaboration between groups. Starting with the end SDTM submission goal and working back to how the collection tools can best support it, the presenters will share practical ways that groups can work together to build a clear path from collection to SDTM data submission.
About the Presenters:
Erica has had a leadership role implementing CDASH eCRFs at ViroPharma Incorporated. She is a Manager in Clinical Data Management and holds several certifications in Medidata Rave.
Steve has had a leadership role in application of CDISC data standards for close to a decade. He is currently Manager of Data Standards Implementation at ViroPharma Incorporated and is a member of the CDISC ADaM team.
Mario is (and for a long time has been) extensively involved in CDISC standards application and is a member of the CDISC ADaM Team.
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).
Access Information
Registered persons will be sent an email the afternoon of Friday, September 6, with the access information to join the webinar and the link to download and print a copy of the presentation slides.
Title: DSMBs/DMCs
Presenter: Scott Evans, Harvard University
Date and Time: Thursday, September 12, 2013, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section
Registration Deadline: Tuesday, September 10, at 12:00 p.m. Eastern time
Description:
Review of interim clinical trial data has many potential advantages: an ethical attractiveness with potentially fewer patients exposed to possibly harmful or ineffective therapies;
economic savings with smaller expected sample sizes and shorter trial durations saving money, time, and other resources; and public health advantages as answers are available more
quickly to the medical community. For many years Data Safety Monitoring Boards (DSMBs) or Data Monitoring Committees (DMCs) have played a critical role in the data monitoring
process in clinical trials, helping to protect trial participants and providing recommendations to improve the scientific value of trials while preserving scientific integrity.
However poor DSMB/DMC practices are common, threatening trial integrity, and leading to sub-optimal recommendations, decision-making, and patient care. In addition, many modern
challenges associated with DSMB/DMC processes have emerged (e.g., the role of DSMBs in adaptive designs, the need for DSMB/DMC member indemnification, and appropriate
training/experience for DSMB/DMC members). In this webinar I will: define a DSMB/DMC; discuss membership, roles, when SDMBs/DMCs are needed, charters and organization, the
importance of an informed and diligent independent statistician, communications and the flow of information, meetings, recommendations, and statistical and operational issues. I
will also provide suggestions for planning for meetings and preparing quality reports that will facilitate efficient and effective DMC's evaluation of interim data. In addition,
although clear solutions to modern and future challenges are still evolving, I will offer thoughts as to whether changes to DSMB/DMC processes are needed to address these
challenges.
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).
Access Information
Registered persons will be sent an email the afternoon of Tuesday, September 10, with the access information to join the webinar and the link to download and print a copy of the
presentation slides.
Title: Preparing to Share CDISC SDTM Data: A Practical Look at How to Conduct and Document Review of SDTM Data and Documentation
Presenter: Steve Kirby, Mario Widel, and Adam Young
Date and Time: Tuesday, September 24, 2013, 12:00 p.m. - 1:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts
Registration Deadline: Friday, September 20, at 12:00 p.m. Eastern time
Description:
CDISC SDTM standards can help get needed new drugs to patients by streamlining the FDA submission process and strengthening scientific collaboration in drug discovery. For that potential to be reached, data providers need to demonstrate (through review) that SDTM standards were accurately applied. SDTM data review needs to establish that: 1) the data as mapped are complete and consistent with the source information, 2) the data conform to the applicable SDTM standards, 3) the data documentation (define.xml and blankcrf.pdf) are consistent with the data. Using examples, the presenters will share review approaches (including documentation suitable for a broad audience of downstream consumers) appropriate for each review category.
About the Presenter:
Steve has had a leadership role in application of CDISC data standards for close to a decade. He is currently Manager of Data Standards Implementation at ViroPharma Incorporated and is a member of the CDISC ADaM team.
Mario is (and for a long time has been) extensively involved in CDISC standards application and is a member of the CDISC ADaM Team.
Adam is a leader in validation programming at ViroPharma Incorporated and has investigated the limits of programmatic review of SDTM content.
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).
Access Information
Registered persons will be sent an email the afternoon of Friday, September 20, with the access information to join the webinar and the link to download and print a copy of the presentation slides.
Title: Detecting Safety Signals Among Adverse Events in Clinical Trials
Presenter: Richard Zink, JMP Life Sciences, SAS Institute, Inc.
Date and Time: Wednesday, October 23, 2013, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section
Registration Deadline: Monday, October 21, at 12:00 p.m. Eastern time
Description:
The analysis of adverse events (AEs) in clinical trials is beset with numerous difficulties. Previous experience in the therapeutic area or drug class under investigation may
suggest events appropriate for pre-specified hypotheses. However, AEs occur spontaneously throughout the trial and may include numerous unexpected events. This presents a
significant multiplicity problem for comparing the AE profiles of two or more treatment arms. At odds are the need to avoid Type I errors without overly sacrificing the power to
detect important differences between treatments. In this webinar we review the difficulties associated with the analysis of adverse events in clinical trials and describe methods
for multiplicity adjustment, one of which considers event groupings such as system organ class. Alternatively, we present Bayesian hierarchical models that borrow strength across
event groupings or subgroups based on demographic characteristics. Meta-analysis and varying treatment exposures will be discussed, and we highlight various graphical techniques
used to summarize results.
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).
Access Information
Registered persons will be sent an email the afternoon of Monday, October 21, with the access information to join the webinar and the link to download and print a copy of the
presentation slides.
Title: Signal Detection Methods for Large Drug Safety Reporting Databases
Presenter: Ram Tiwari, FDA
Date and Time: Wednesday, December 4, 2013, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section
Registration Deadline: Monday, December 2, at 12:00 p.m. Eastern time
Description:
In this webinar, first, a comprehensive review of commonly used frequentist and Bayesian methods for signal detection from large drug safety databases, such as FDA's Adverse Event Reporting System (AERS, now FAERS), consisting of spontaneous reports on adverse events for post-market drugs, is presented; then a newly developed method namely, a likelihood ratio test (LRT) based method (Huang et al., Jour Amer Stat Assoc, 2011), is discussed in detail. The applications of LRT tool to AERS data will be presented. Some extensions of LRT method are also briefly discussed.
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).
Access Information
Registered persons will be sent an email the afternoon of Monday, December 2, with the access information to join the webinar and the link to download and print a copy of the presentation slides.
About Webinars
A webinar is a seminar conducted over the World Wide Web-a type of web conferencing. In contrast to a webcast, which is transmission of information in one direction only, webinars are designed to be interactive between the presenter and audience. A webinar is 'live' in the sense that information is conveyed according to an agenda, with a starting and ending time. The presenter speaks over a standard telephone line, pointing out information being presented on the screen. The audience can respond via a chat feature. The word 'webinar' is a blend of web and seminar.