As a part of Cytel’s Advanced Design Framework, a new Framework for the statistical design of clinical trials, Cytel discovered that a specific combination of process changes and technological advances has the potential to increase clinical development productivity by 10-20%. The Framework summarizes these as Thoroughly Explore, Decide Together and Communicate Tradeoffs. Here are 7 key features of this improved strategic framework. Alternatively, watch the webinar of our Chief Scientific Officer Yannis Jemiai discussing this Advanced Design Framework.
Thoroughly Explore
1: Explore more clinical trial design options: Give statisticians time and latitude to explore all the designs that correspond with your commercial goals.
2: Ensure statisticians are strategically deployed: Ensure statisticians know what these commercial goals are –in terms of speed, savings, success – and how you prioritize them, so that statisticians can generate a number of designs.
3: Ensure statisticians are well-resourced: New technology enables more thorough exploration of statistical design both in less time, and in real-time. Shave months off the clinical development process. Learn more.
Decide Together
4: Collaborate across stakeholders: Every clinical development meeting has multiple stakeholders. A quantitative evaluation tool can ensure that each viewpoint is given necessary weight to align perspectives.
5: Set collective goals early: Commercial goals can vary, from creating accelerated trials to powering trials. Agree on these over-arching goals early, before discussing clinical trial design.
Communicate Tradeoffs
6: Understand the tradeoffs available: Would you increase trial length by 4 months if it meant a better powered trial? How many patients would you enroll earlier in that case? Make sure every team member understands these tradeoffs.
7: Communicate with visuals: A number of the tradeoffs development teams discuss are nuanced. Even experienced teammates might be confused. Use visuals to communicate clearly.
Join the first webinar in our C-Suite Webinar Series to learn how preliminary testing of Cytel’s Advanced Design Framework has consistently identified opportunities to increase clinical development productivity 10-20%.
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