Education > Continuing Education

K-12

Web-Based Lectures

Previously recorded webinars are available through the LearnSTAT OnDemand program.

Current Webinar Offerings:

June 12, 2013	An Introduction to Joint Models for Longitudinal and Time-to-Event Data
June 26, 2013	Bayesian Methods for Genomic Based Studies of Disease
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
November 20, 2013	Design and Analysis of Experiments in Blocks: Should We Do What the Textbooks Say?
December 4, 2013	Signal Detection Methods for Large Drug Safety Reporting Databases

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).

Registration is Closed

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: Bayesian Methods for Genomic Based Studies of Disease
Presenter: Christina Kendziorski
Date and Time: Wednesday, June 26, 2013, 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, June 24, at 12:00 p.m. Eastern time

Description:
Genomic based studies of disease now involve highly diverse types of data collected on large groups of patients. A major challenge facing statistical scientists is how best to combine the data, extract important features, and comprehensively characterize the ways in which the features affect an individual's disease course and likelihood of response to treatment. In this webinar, I will review Bayesian methods that have been developed toward this end. Because the development and/or evaluation of any method requires a solid understanding of the data in question, I will begin with a review of next-generation sequencing (NGS) technologies, with a focus on NGS of mRNA, so-called RNA-seq experiments. I will also review the data available in the Cancer Genome Atlas (TCGA) project. These two data sets will be used to illustrate Bayesian methods we and others have developed for identifying differentially regulated genes in an RNA-seq experiment, as well as methods for data integration and patient-specific prediction of survival and treatment response. The course is designed primarily for PhD students and postdocs in the statistical sciences who are interested in Bayesian applications to high-throughput genomic studies.

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

Access Information
Registered persons will be sent an email the afternoon of Monday, June 24, 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

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

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

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

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: Design and Analysis of Experiments in Blocks: Should We Do What the Textbooks Say?
Presenter: Peter Goos, University of Antwerp
Date and Time: Wednesday, November 20, 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, November 18, at 12:00 p.m. Eastern time

Description:
Many design of experiments textbooks contain tables that tell you how to run two-level full or fractional factorial designs in blocks. The use of the tables requires understanding the concepts design generator, blocking generator and confounding, and deliberately sacrificing the estimability of certain interaction effects. In this webinar, you will see that the textbooks' tables do not necessarily produce good designs, and that it is often easy to construct better designs, by hand. But that is not the end of the story: by using modern design of experiments software, you can generate even better designs. Throughout the webinar, the pros and cons of the classical designs in the textbooks and the modern designs generated by software are discussed in detail. Apart from telling what designs to use for blocked experiments, the textbooks also discuss the analysis of the resulting data. In doing so, textbooks make a major assumption, being that the block effects are fixed unknown parameters. This assumption is oftentimes incorrect, and it leads to a less informative data analysis. Assuming the block effects are unknown random variables is a better alternative in many instances. The webinar will therefore also provide a detailed comparison of random and fixed block effects, and include a discussion of the design implications of working with random block effects. For instance, a new criterion for selecting designs in the presence of random blocks is presented and the possibility to run smaller experiments is investigated. The webinar will end with an illustration of the design of a response surface experiment run in blocks. The leading examples throughout the webinar are a vitamin stability experiment and a pastry dough experiment.

Registration Fees:
Members of Q&P: $75
Members of SPES: $75
Members of SSC-BISS: $75
ASA Members: $90
Nonmembers: $105

Access Information
Registered persons will be sent an email the afternoon of Monday, November 18, 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

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.