May 2013 | Tufts CSDD Internal News
The Adoption and Impact of Adaptive Trial Designs
Tufts CSDD hosted and facilitated a Senior Leadership roundtable on February 13, 2013 in Boston to discuss and share insights into the adoption and impact of adaptive design clinical trials. Forty senior executives from a variety of cross-functional areas participated in the roundtable including clinical research and development, biostatistics, project management, and clinical operations. Perspectives on the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) positions regarding the use of adaptive designs were also discussed. In addition to facilitated discussion, Tufts CSDD presented the results of interviews conducted among directors and heads of statistical functions from a dozen major pharmaceutical companies and provided forecasted impact metrics based on a simple model of trial design adaptation. A large pharmaceutical company also presented a case study on implementing adaptive trial design practices at the portfolio level throughout the organization. This Senior Leadership Brief summarizes key takeaways and insights from the roundtable and was funded by an unrestricted educational grant from Aptiv Solutions.