Vladimir Dragalin
Janssen Pharmaceuticals
Objectives:
The use of adaptive designs can increase the efficiency of drug development by improving our ability to efficiently learn about the dose–exposure–response and better determining whether to take a drug forward into latter phase testing and at what dose. Adaptive designs often employ frequent interim analyses of all accumulated data (and, possibly, external trial data) to determine whether pre-planned design modifications will be ‘triggered’. Interim analyses partition the trial into multiple stages, each trial stage’s characteristics (number of treatment arms, number of patients to be enrolled, their allocation between arms, stage duration, etc.) defined by the preceding interim analysis results. The ability to periodically, or even continually, examine available data to determine whether trial modifications are necessary and, when indicated, implement pre-defined design changes gives adaptive design its strength and flexibility.
Methods:
We will provide an overview of available adaptive designs appropriate for clinical trials. We will discuss also about the current trends seen across industry in regard to uptake of adaptive designs. We will examine which types of adaptive designs are at the forefront, and those that are taking longer to gain traction, how the uptake of adaptive trial designs is not only a matter of design, but also a matter of finding solutions to sometimes complex trial execution challenges.
Results:
As with any new advance in innovation, there are always leaders and followers. Even for the most progressive of companies with capable internal statistical teams, the challenges to greater uptake can be complex ones. Along with challenges there is also an emergence across industry of alternative solutions. We will discuss the range of approaches that encompass “one off” work around solutions, through to solutions that are ultimately aimed at the implementation of adaptive trials on a broad scale, through a combination of process and technology changes.
Conclusions:
For over a decade adaptive designs have been pushing at traditionally held beliefs and practices. Uptake may be slower than anticipated. However, through this session the audience will learn how progress is continuing to be made, and how the introduction of adaptive trials may ultimately lead to an overall improvement by industry in the way trial design options are evaluated and all trials are executed.
Reference: PAGE () Abstr 9241 [www.page-meeting.org/?abstract=9241]
Poster: Oral: Keynote lecture