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Innovative Trial Designs in Early Phase Oncology

The world is now onboard

Innovative adaptive designs, though on the rise, continue to be underutilized. While adaptive designs are not relevant for every study, there is still substantial untapped opportunity to take advantage of these powerful innovations in oncology clinical research, particularly in the early phases. We explore opportunities and case studies in our latest publications. Learn from leading members of PPD’s adaptive design and master protocol working groups as they explore potential scientific and operational implications—along with approaches to address potential challenges.

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Our experience in submitting protocols with adaptive designs in early stage oncology trials to U.S. and European regulators is that they not only accept these designs—if anything they actively encourage them. Investigators, too, have a growing understanding of the many benefits of these approaches. The world is now onboard.

Jürgen Hummel
Senior Director of Statistical Science