Learn on the features, advantages and disadvantages of adaptive designs and group-sequential designs and their regulatory aspects of Phase II/III trials in oncology!
ABSTRACT:
Particularly in oncology, it is often the case that after seeing promising signals in phase I expansion cohorts, Sponsors want to expedite drug development. Merging the exploratory (phase II) and the confirmatory (phase III) phases into a single trial and/or a single protocol is regarded as a means to achieve this goal, sometimes with a view towards accelerated approval. Traditionally, group-sequential designs have an established role in randomized trials and allow for safety monitoring as well as early decisions regarding efficacy and futility of the new treatment in phase III studies. More recently, adaptive designs that enable implementation of modifications to key components of the trial design (targeted treatment effect/sample size, treatment groups, population selection) have become popular despite the fact that they require advanced statistical input and come with additional logistical burden.
During this webinar,
- A Sponsor and a Statistician will debate about the distinctive features of these approaches, the applicable regulations, and the advantages and disadvantages of the various approaches.
- They will address methodological questions such as: what does operationally seamless phase II/III mean? What is the difference between a phase II/III and a phase III trial with interim stopping rules? Do all phase II/III studies use an adaptive design?
- They will also discuss the information that is accessible to the Sponsor at the end of the phase II and logistical implications of the various approaches. Moreover, we will discuss the regulators’ views and illustrate our discussion with practical examples.
KEY TAKEAWAYS:
- Be exposed to the concepts of operationally and inferentially seamless designs, adaptive designs and group-sequential designs
- Gain insights into the regulatory and operational aspects of such designs
- Understand the benefits and limitations of various time-saving clinical study designs in relation to information available at the time of study conception
SPEAKERS:
