Clinical trial design has evolved substantially in recent years. As sponsors implement more complex and adaptive protocols with features like expansion cohorts, the lines between phases are blurring, creating new ethical challenges. Expansion cohorts typically involve larger trial populations than traditional designs—requiring a careful eye toward participant safety. Adaptive trials are iterative, meaning that as the data evolves, informed consent (and reconsent) may need to also. IRBs have had to tackle these and other ethical challenges in this new era of advanced trial design, especially during first-in-human and early-phase studies. During this webinar, we’ll explore that shifting landscape and how it’s expanding IRB responsibilities and expectations. You’ll learn: Common ethical challenges associated with evolving trial designs What IRBs should consider when reviewing complex Phase 1 studies Best practices to maintain rigor and quality in ethical review as study designs further evolve
