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.
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
The largest untapped opportunities are arguably in the early phases of clinical development where adoption of innovative designs may, in fact, help support an accelerated approval.
Dirk Reitsma, M.D. Vice President, Global Product Development