Web-Based Lectures






Title: Sensitivity Analysis in Observational Research: Introducing the E-Value
Presenter: Tyler VanderWeele
Date and Time: Tuesday, April 24, 2018, 2:00 p.m. – 3:30 p.m. Eastern time
Sponsor: Mental Health Statistics Section

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

Description:
Sensitivity analysis is useful in assessing how robust an association is to potential unmeasured or uncontrolled confounding. This webinar introduces a new measure called the “E-value,” which is related to the evidence for causality in observational studies that are potentially subject to confounding. The E-value is defined as the minimum strength of association, on the risk ratio scale, that an unmeasured confounder would need to have with both the treatment and the outcome to fully explain away a specific treatment–outcome association, conditional on the measured covariates. A large E-value implies that considerable unmeasured confounding would be needed to explain away an effect estimate. A small E-value implies little unmeasured confounding would be needed to explain away an effect estimate. The speaker and his collaborators propose that in all observational studies intended to produce evidence for causality, the E-value be reported or some other sensitivity analysis be used. They suggest calculating the E-value for both the observed association estimate (after adjustments for measured confounders) and the limit of the confidence interval closest to the null. If this were to become standard practice, the ability of the scientific community to assess evidence from observational studies would improve considerably, and ultimately, science would be strengthened.

Registration Fees:
Member of the Mental Health Statistics Section: $60
ASA Member: $90
Nonmember: $110

Each registration is allowed one web connection. Sound is received via audio streaming from your computer’s speakers. 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, April 20, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




Title: Clinical Graphs Using SAS®
Presenter: Sanjay Matange
Date and Time: Thursday, May 10, 2018, 12:00 p.m. – 1:00 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts

Registration Deadline: Tuesday, May 8, at 12:00 p.m. Eastern time

Description:
Graphs are essential for many clinical and health care domains, including analysis of clinical trials safety data and analysis of the efficacy of the treatment, such as change in tumor size. Creating such graphs is a breeze with procedures from SAS® 9.4 ODS Graphics. This webinar shows how to create many industry-standard graphs such as Lipid Profile, Swimmer Plot, Survival Plot, Forest Plot with Subgroups, Waterfall Plot, and Patient Profile using Study Data Tabulation Model (SDTM) data.

Sanjay Matange is R&D Director in the Data Visualization Division responsible for the development and support of the ODS Graphics system, including the GTL, SG procedures, ODS Graphics Designer and related software. Sanjay is the author of four SAS Press books and the author of four Patents.

We will conclude with a Q&A session. Please note that there are no open phone lines so the audience submits their questions using a chat feature built into the webinar dashboard.

Registration Fees:
Member of the Section for Statistical Programmers and Analysts: $0
ASA Members: $59
Nonmembers: $74

Each registration is allowed one connection to the webinar. 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, May 8, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




Title: Adaptive Enrichment Trial Designs: Statistical Methods, Trial Optimization Software, and Case Studies
Presenter: Michael Rosenblum
Date and Time: Tuesday, May 15, 2018, 12:00 p.m. – 1:30 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Friday, May 11, at 12:00 p.m. Eastern time

Description:
This webinar focuses on adaptive enrichment designs, that is, designs with preplanned rules for modifying enrollment criteria based on data accrued in an ongoing trial. For example, enrollment of a subpopulation where there is sufficient evidence of treatment efficacy, futility, or harm could be stopped, while enrollment for the complementary subpopulation is continued. Such designs may be useful when it’s suspected that a subpopulation may benefit more than the overall population. The subpopulation could be defined by a risk score or biomarker measured at baseline. Adaptive enrichment designs have potential to provide stronger evidence than standard designs about treatment benefits for the subpopulation, its complement, and the combined population. We present new statistical methods for adaptive enrichment designs, simulation-based case studies in Stroke and Heart Disease, and open-source adaptive design optimization software. The tradeoffs involved in using adaptive enrichment designs, compared to standard designs, will be presented. Our software searches over hundreds of candidate adaptive designs with the aim of finding one that satisfies the user’s requirements for power and Type I error at the minimum sample size, which is then compared to simpler designs in terms of sample size, duration, power, Type I error, and bias in an automatically generated report.

Registration Fees:
Biopharmaceutical Section Members: $0
ASA Members: $59
Nonmembers: $74

Each registration is allowed one web connection. Sound is received via audio streaming from your computer’s speakers. 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 11, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




Title: Efficiency and Estimation for Adaptive Designs with Unblinded Sample Size Re-estimation
Presenter: Cyrus R Mehta
Date and Time: Thursday, May 24, 2018, 12:00 p.m. – 1:00 p.m. Eastern time
Sponsor: Section on Medical Devices and Diagnostics

Registration Deadline: Tuesday, May 22, at 12:00 p.m. Eastern time

Description:
Clinical trials with adaptive sample size re-assessment, based on an analysis of the unblinded interim results have gained in popularity due to uncertainty regarding the value of δ at which to power the trial at the start of the study. In implementing such designs one must address three statistical issues:

  • How to control the type-1 error
  • How to construct an optimal decision rule for increasing the sample size
  • How to estimate δ at the end of the study

In this presentation I will address all three issues.

Registration Fees:
Member of the Section for Medical Devices and Diagnostics (MDD): $40
ASA Member: $65
Nonmember: $85

Each registration is allowed one web connection. Sound is received via audio streaming from your computer’s speakers. 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 Tuesday, May 22, with the access information to join the webinar and the link to download and print a copy of the presentation slides.




Title: Assessing Biosimilarity and Interchangeability: Issues and Recent Development
Presenter: Shein-Chung Chow
Date and Time: Tuesday, June 19, 2018, 12:00 p.m. – 2:00 p.m. Eastern time
Sponsor: Biopharmaceutical Section

Registration Deadline: Friday, June 15, at 12:00 p.m. Eastern time

Description:
Biological drugs are much more complicated than chemically synthesized, small-molecule drugs. For instance, their size is much larger and structure is more complicated. In addition, they can be sensitive to environmental conditions such as light, temperature or pressure. Moreover, they may expose patients to immunogenic reactions. Consequently, the assessment of biosimilarity and interchangeability calls for greater circumspection than the evaluation of bioequivalence. The FDA recommends the use of stepwise approach for obtaining totality-of-the-evidence for demonstration of biosimilarity and interchangeability. The stepwise approach involves analytical similarity assessment, animal studies for toxicity, pharmacokinetic and pharmacodynamics (PK/PD) studies for pharmacological activities, clinical studies including immunogenicity for safety, tolerability, and efficacy. The present communication discusses some current issues and recent development related to the assessment of biosimilarity and interchangeability of biosimilar products. The current issues include (1) biosimilar versus biobetter, (2) how many biosimilar studies are required?, (3) multiple reference products, (4) criteria for highly variable drug products, (5) development of biosimilarity index, (6) analytical similarity assessment for critical quality attributes, (7) drug interchangeability in terms of switching and alternation, (8) study designs that are useful for the assessment of biosimilarity and drug interchangeability, and (9) the issue of (post-approval) non-medical switching, (10) extrapolation of data (both analytical and clinical) across different indications. These issues and corresponding recent development will be discussed.

Registration Fees:
Biopharmaceutical Section Members: $0
ASA Members: $59
Nonmembers: $74

Each registration is allowed one web connection. Sound is received via audio streaming from your computer’s speakers. 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, June 15, with the access information to join the webinar and the link to download and print a copy of the presentation slides.