Advanced Design Framework Part 3 – Communication Techniques To Ensure Alignment On Data-Driven Clinical Trial Designs

Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on decades of experience increasing clinical development productivity. The Framework illustrates how advances in design processes and technology can help development teams deliver greater business results, unifying statistics and strategy in the era of cloud computing and making strategic use of well-resourced statisticians.

The framework consists of three parts: Thoroughly Explore, Decide Together, and Communicate Tradeoffs. In this blog we take a deeper look into the third part of this Framework, revealing how clear articulation of the chosen design’s benefits and drawbacks can help ensure data-driven decision-making that improves speed-, savings and success.

The stakes are high in pharmaceutical development, and selection of the statistical trial design often requires several layers of approval before a team has authorization to proceed. These debates often revisit the specific contextual strategies necessary to make a new a new therapy, device or biologic commercially viable. Given the constantly changing conditions of the pharmaceutical development industry, this often requires intense and nuanced conversations about the distribution and availability of resources, the situation of competitors, and the long-term goals of a corporate portfolio.