In recent years, the demand for creative approaches to drug development has increased. In ALS research, for example, patient advocates and regulatory bodies have encouraged researchers to adopt more flexible clinical trial design models, with the hope that such designs will lead to faster development of treatments. Trials in which key components are modified during the course of the study, and in response to information accrued within the trial, may be described under a number of terms—including as adaptive, umbrella, and platform trials. IRBs may find the terminology used to categorize these studies and the rationale for these trial designs challenging—and grappling with the potential substantive ethical issues even more so. During this webinar, speakers will define key terms, explore ethical and regulatory challenges, and provide strategies and examples to bridge the gap between IRBs and researchers in understanding adaptive trial designs. (Presented on June 18, 2020)

Agenda

• Defining key terms such as "platform" and "adaptive" designs, as well as their value and utility
• Ethical and regulatory challenges with these designs, including questions around maintaining equipoise, ensuring informed consent, and monitoring adaptive changes made during the study
• Strategies and real-world examples for IRBs, including in-depth look at an ongoing ALS platform trial and the strategies used for addressing ethical issues that arose in its design

Learning Objectives
After viewing this webinar, attendees will be able to:

• Define key terms and compare trial design models
• Identify the value and utility of complex trial designs
• Describe associated ethical and regulatory issues
• Implement strategies for navigating these issues

Who should attend?
This webinar will benefit IRB/HRPP members and staff. Researchers, sponsors, and academic institutions may also benefit from attending.

Continuing Education
Webinar participants holding the Certified IRB Professional (CIP^®) credential may apply 1.25 continuing education credits towards CIP recertification. Learn More »

Access Interval
Access to purchased content will be available for 90 days after the date of purchase. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. Content purchased prior to January 1, 2021 will remain available indefinitely. After access has expired, users can purchase an additional 90 days of access.

If you'd prefer a paper form, please click here. Please send the completed form to registration@primr.org.