The consortium delivers a platform and process map for the integrated design of exploratory phase adaptive trials

Founded in 2013, the ADDPLAN DF Consortium is comprised of Novartis Pharma AG, Janssen Pharmaceuticals Inc., Eli Lilly, and ICON.

Currently half of Phase III trials fail, in part because of poor dose selection in Phase II. Many designs focus on too few and too narrow a range of doses, often forcing sponsors to repeat studies to find the minimum effective dose, resulting in increased overall cost, duration, and unnecessary patient risk. Also, the most common statistical methods for estimating target dose are prone to uncertainty, which can result in the use of an inappropriate statistical model that over- or under-estimates the true effective dose.

The Consortium will work collaboratively to address these challenges by:

  • Developing new statistical methodologies for the design of innovative dose-finding clinical trials, with an emphasis on adaptive designs
  • Focusing on enhancing the trial execution technologies required to handle the multiple adaptations integral to complex adaptive dose-finding trials
  • Integrating and validating these methodologies into ADDPLAN DF software for the design, planning, and analysis of dose finding trials, and ensuring that these designs are easily implemented through ADDPLAN®, the ICON proprietary trial execution platform