Education > Continuing Education

Web-Based Lectures

Previously recorded webinars are available through the LearnSTAT OnDemand program.

Current Webinar Offerings:


May 24, 2016 Global Sensitivity Analysis of Randomized Trials with Informative Drop-out
June 9, 2016 Enhancing the Value of Qualitative Research Using the Total Quality Framework (TQF)
June 16, 2016 Basket Design of Phase III Confirmatory Trials
July 7, 2016 Pushing the Frontier of TFL Automation and Dynamic Visualization with R/Shiny
July 14, 2016 Enabling Reproducibility in Statistical Analyses Using R Markdown
September 15, 2016 An Overview of Statistical Considerations in Clinical Validation of Companion Diagnostic Devices of Precision Medicine
October 6, 2016 Introduction to Stan - From Logistic Regression to PK/PD ODE Models




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Title: Global Sensitivity Analysis of Randomized Trials with Informative Drop-out
Presenter: Daniel Scharfstein, John Hopkins University
Date and Time: Tuesday, May 24, 2016, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Friday, May 20, at 12:00 p.m. Eastern time

Description:
We present a formal methodology for conducting sensitivity analysis of randomized trials in which outcomes are scheduled to be measured at fixed points in time after randomization and some subjects prematurely withdraw from study participation. We motivate our methods by a placebo-controlled randomized trial designed to evaluate a treatment for bipolar disorder. We present a comprehensive data analysis and a simulation study to evaluate the performance of our methods. A software package entitled SAMON (R and SAS versions) that implements our methods is available at www.missingdatamatters.org

Registration Fees:
Biopharmaceutical Section Members: $0
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, May 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: Enhancing the Value of Qualitative Research Using the Total Quality Framework (TQF)
Presenter: Margaret R. Roller (Roller Research) and Paul J. Lavrakas (Independent Consultant)
Date and Time: Thursday, June 9, 2016, 1:00 p.m. - 3:00 p.m. Eastern time
Sponsor: Survey Research Methods Section

Registration Deadline: Tuesday, June 7, at 12:00 p.m. Eastern time

Description:
Oftentimes a research question cannot be answered well through the use of quantitative research or through the exclusive use of quantitative approaches. For example, quantitative survey data may leave a researcher with unanswered questions about the reasons that underlie the responses or the particular contexts in which respondents framed their answers. That is why statisticians and other quantitative researchers are on occasion involved in conceptualizing, conducting, interpreting, and/or reviewing research projects that include the use of qualitative research methods.

Qualitative research goes beyond the expedient to gain a richer, more intricate appreciation of the research issue. Deriving these complex and contextual data, however, presents unique challenges to researchers who attempt to combine the essence of qualitative research with reliable and valid approaches that maximize the usefulness of their research. It may be because of these challenges that quality-design issues related to qualitative research - such as coverage, sample selection, nonresponse (including missing data), and researcher bias - have heretofore received relatively modest consideration by the qualitative research community.

In this presentation, we introduce a new approach that brings greater rigor to qualitative research. That approach is the Total Quality Framework (TQF) (Roller & Lavrakas, 2015). The TQF provides researchers with a systematic yet highly flexible way to (a) give explicit attention to reliability and validity issues in qualitative research, (b) critically examine the possible sources of bias and inconsistency in qualitative methods, (c) incorporate features into qualitative research designs that try to mitigate these effects, (d) acknowledge and take their implications into consideration during analysis, and (e) thereby maximize value of the research outcomes.

Our presentation: 1) presents a brief overview of what makes qualitative research uniquely different from quantitative; 2) explains the TQF and its value for conceptualizing, implementing, interpreting, and reviewing qualitative research; and 3) illustrates the application of the TQF by way of two qualitative methods, in-depth interviews and focus group discussions. It is intended that our presentation will help quantitative researchers think more critically and confidently about the value that qualitative methods can bring to their studies.

Registration Fees:
SRMS Members: $60
AAPOR 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 Tuesday, June 7 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: Basket Design of Phase III Confirmatory Trials
Presenter: Cong Chen, Merck
Date and Time: Thursday, June 16, 2016, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Tuesday, June 14, at 12:00 p.m. Eastern time

Description:
The discovery of numerous molecular subtypes of common cancers leads to the investigation of biomarkers potentially predictive of treatment effect of an experimental treatment in multiple histologies. However, the prevalence of a putative predictive biomarker within a histology is often low, which makes it challenging to enroll adequate number of patients in a conventional histology-based confirmatory trial. An alternative approach is to study patients with a common biomarker signature in a "basket" trial across multiple histologies. This study design has previously been used to explore experimental therapies with potentially transformative effects. We present a general design concept of a Phase 3 basket trial broadly applicable to any effective therapy. The trial is designed with scientific and statistical rigor to enable the approval of an experimental treatment in multiple tumor indications based on the outcome from a single study. Given the difficulty in indication selection, the basic idea is to prune the inactive indications at an interim analysis and pool the active indications in the final analysis. A critical statistical issue of the basket design is Type I error control for the pooled analysis after pruning. While pruning may be seen as cherry-picking which tends to inflate the Type I error, it also shares similarity with a binding futility analysis which tends to deflate the Type I error if all indications are pruned. The net impact of pruning is complicated. The use of different endpoints for pruning and pooling further complicates the issue. This webinar will provide statistical details on Type I error control for the general basket design concept under three sample size adjustment strategies after pruning. Power and sample size calculations are also provided. Comparisons are made to a straightforward design without pruning.

Registration Fees:
Biopharmaceutical Section Members: $0
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 Tuesday, June 14, 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: Pushing the Frontier of TFL Automation and Dynamic Visualization with R/Shiny
Presenters: Danni Yu, Eli Lilly and Company and Tuan Nguyen Sr., Eli Lilly and Company
Date and Time: Thursday, July 7, 2016, 11:00 a.m. - 12:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts

Registration Deadline: Tuesday, July 5, at 12:00 p.m. Eastern time

Description:
Producing TFLs can be a tedious, time-consuming, expensive and painful process. It has been challenging to automate until the arrival of new technologies. Shiny is a R tool for building web-based GUI for statistical analyses and is well-suited for automation. In addition, Shiny is built for dynamic visualization/analyses; this key feature allows us to interact with data dynamically, thus enabling proactive engagement with physicians/scientists. We will give some examples on how R/Shiny is used to lead innovation in drug development.

About the Presenters:
Danni Yu (Research Scientist, Oncology Biomarker Statistics, Eli Lilly and Company) and Tuan Nguyen (Sr. Research Scientist, Oncology Biomarker Statistics, Eli Lilly and Company). Dr. Yu and Dr. Nguyen and colleagues developed a comprehensive automation platform based on the R and Shiny tools that allows for fast, dynamic, scalable, inexpensive and reproducible visualization/analyses and generation of TFLs in drug development.

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 Tuesday, July 5, 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: Enabling Reproducibility in Statistical Analyses Using R Markdown
Presenter: Eric Nantz, Eli Lilly and Company
Date and Time: Thursday, July 14, 2016, 11:00 a.m. - 12:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts

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

Description:
Reproducibility in statistical analyses has always been an important topic in many fields of statistics, but has gained even more attention in the last few years. In the past, the software tools enabling reproducibility in statistical programming required a large investment in time and effort. However, a new ecosystem around reproducibility has emerged within the R statistical language. In this talk, I will demonstrate specific examples using R in combination with rmarkdown and additional packages to make analysis reproducibility easy to set up and maintain throughout the life cycle of a project.

About the Presenter:
Eric Nantz is a senior research scientist supporting advanced analytics within the immunology unit at Eli Lilly and Company. Eric has utilized R in a wide variety of analyses involving clinical and novel biomarker data sets. Eric is also the creator and host of the R-Podcast, an audio podcast that provides valuable information for both new and experienced R users to accomplish data analyses.

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 Tuesday, July 12, 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: An Overview of Statistical Considerations in Clinical Validation of Companion Diagnostic Devices of Precision Medicine
Presenter: Meijuan Li, FDA
Date and Time: Thursday, September 15, 2016, 12:00 p.m. - 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Tuesday, September 13, at 12:00 p.m. Eastern time

Description:
A key component of precision medicine is companion diagnostics that measure biomarkers e.g. protein expression, gene amplification or specific mutations. For example, most of the recent attention concerning molecular cancer diagnostics has been focused on the biomarkers of response to therapy, such as KRAS mutations in metastatic colorectal cancer, EGFR mutations in advanced Non-small cell lung cancer, and BRAF mutations in metastatic malignant melanoma. The presence or absence of these markers is directly linked to the response rates of particular targeted therapies with small-molecule kinase inhibitors or antibodies. Therefore, testing for these markers has become a critical step in the target therapy of the above-mentioned tumors. A companion diagnostic device is essential for the safe and effective use of a corresponding therapeutic product. The validation of a new companion diagnostic device includes both measurement and clinical validation as it is intended to be used. In this webinar we aim to cover the following important aspects of companion diagnostic device clinical validation (1) different indications for use and study designs (2) companion diagnostic device clinical performance measures (3) companion diagnostic device bridging study (4) follow-on companion diagnostic device (5) the impact of companion diagnostic device measurement performance on clinical validation of precision medicine including samples size calculation.

Registration Fees:
Biopharmaceutical Section Members: $0
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 Tuesday, September 13, 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: Introduction to Stan - From Logistic Regression to PK/PD ODE Models
Presenter: Sebastian Weber, Novartis Pharma AG
Date and Time: Thursday, October 6, 2016, 10:00 a.m. - 12:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Tuesday, October 4, at 12:00 p.m. Eastern time

Description:
The Stan project is in development since 2011 and aims to enable efficient Bayesian inference. This tutorial will focus on the foundations of Stan, introduce the Stan modeling language, explain how to do Bayesian inference with Stan and finally address best practices. These will be introduced using examples of increasing complexity ranging from logistic regression to non-linear population pharmacokinetic/pharmacodynamic ODE models which will demonstrate the scalability and flexibility of Stan. Stan's key feature is the Hamiltonian MCMC sampler which is different than the various established flavors of Bayesian inference Using Gibbs Sampling (BUGS), such as WinBUGS, OpenBUGS, and JAGS. To fully exploit the advantages of Hamiltonian MCMC, participants will be briefly introduced to the foundations of Hamiltonian MCMC. After these more theoretical aspects, the Stan modeling language will be introduced. The Stan modeling language is inspired by the BUGS family such that BUGS users can quickly adopt Stan. Most importantly, participants will be taught best practices to write efficient Stan models. This will include how to debug Stan models easily and what to consider in order to expedite Stan models. These best practices will be presented using examples of increasing complexity. The examples presented will be run using the R package rstan.

Registration Fees:
Biopharmaceutical Section Members: $0
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 Tuesday, October 4, with the access information to join the webinar and the link to download and print a copy of the presentation slides.