Managing Risk in Clinical Trials: The Case for Adaptive Design Methods

A clinical study is only as good as its design. Adaptive design is an innovative methodology that allows cutting costs and time to market while getting the required information on your device or pharma product. Using this methodology, key study design parameters may be modified while the trial is ongoing, based on the data collected. In recent years, both FDA and EMA have become much more receptive to adaptive trials, yielding a paradigm shift from classical to adaptive clinical trial design. This presentation will provide an overview of adaptive design, including the different families of adaptive designs and some of the controversies associated with them.