The session will focus on various types of protocol designs and changes, with an emphasis on adaptive designs. We will review the FDA guidance on “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Taking a deeper dive into unplanned design changes and regulatory considerations, we will engage in one of the oldest thought experiments in Western philosophy, the Ship of Theseus, to address an ambiguity in clinical trial design. Here, we will consider alternative ways protocols are commonly modified, and whether those changes could be considered an entirely new clinical trial, rather than a modification. This session will also provide an educational background in trial design for professionals who haven't had as much exposure to the topic as they wish, and will include a detailed review of sections of ICH E8(R1) and ICH E6(R2), where they relate to trial design.

CEU: 1.00 ACRP

Speaker:

• Amanda Egan, Associate Clinical Research Associate, Merck

Watch a Sneak Peek into the Session Content:

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.