Novel Designs for Oncology Clinical Trials
Despite growing investments in R&D, the number of new molecular entities achieving marketing authorization is not increasing. However, novel approaches to clinical development and trial design could play a significant role in overcoming some of these challenges by improving efficiency and reducing attrition rates. Clinical development can be made more efficient and effective by adopting an integrated research model that increases flexibility and maximizes the use of accumulated knowledge. Central to this approach to drug development are novel tools, including modeling and simulation, Bayesian methodologies and adaptive trial designs, such as seamless adaptive design and sample-size re-estimation.