Overcoming Clinical Development Challenges in Oncology with Innovative, Adaptive Designs: Complimentary Paper
Having its roots in the seminar rooms of the Dana Farber Cancer Institute, Cytel has a long record of establishing new methods in small samples, adaptive designs, Bayesian designs and multi-arm trials, to align statistical rigor to the goal of accelerating clinical development for oncology trials.
For the first time in thirty years, Cytel experts in statistics, data management and functional service provision describe end-to-end delivery of successful trials in oncology, and divulge critical insights about high-quality trial planning and regulatory submission.
This paper will cover a range of topics, such as:
How to build in adaptations for flexibility;
How to use a team of quantitative strategists (statisticians, pharmacologists and data scientists) to mitigate risks and identify opportunities;
How to plan a data management strategy for Complex Innovative Designs;
Why Cytel uses a holistic Phase-to-Plan Approach for Oncology trials.