Web-Based Lectures






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).

Registration is now closed.

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).

Registration is now closed.

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.