Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual

Mar 23, 2023 3:00 PM - Mar 23, 2023 7:00 PM

(US Eastern Standard Time)

Short Course: Group Sequential and Adaptive Designs in Drug Development: Methodology, Practical Aspects, and Examples

This is a Virtual Pre-Conference Short Course in conjunction with the DIA/FDA Biostatistics Industry and Regulator Forum

Overview

*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*


Group sequential and adaptive designs in clinical trials are well-known to increase efficiency in drug development. In the appropriate scenarios, they offer the flexibility of mid-trial modifications that reduce sample size or overall timeline. This short course will start with introducing the fundamental theory of group sequential and adaptive designs. The second part of the course will dive deeper into related topics, such as inference following such designs, their practical implementation, and real-life examples. Thereafter, more complex designs combining group sequential elements with multiple testing procedures will be covered. Finally, the session will close with recommendations including regulatory guidance. This course is for statistical researchers in the pharmaceutical industry, academic institutions, regulatory agencies, and statistics students with basic or intermediate level of knowledge about clinical trial design. It is oriented towards practitioners who (i) are interested in using group sequential / adaptive designs in medical product development; (ii) are interested to understand the methodological perspectives; and (iii) are interested to learn the practical aspects related to their implementation.


Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Learning objectives

Upon completing this course, attendees will be able to:
  • Evaluate the need for flexible design for a clinical program
  • Discuss the basic statistical concepts and principles of group sequential and adaptive designs
  • Identify relevant software and the regulatory landscape
  • Assess findings and communicate them with non-statisticians

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.