Groundbreaking innovations in basic science are “pushing” clinical development to be agile and creative, with the intent of translating scientific discoveries into medical benefit more rapidly and convincingly. Clinical development is shifting from the traditional static Phase I-II-III structure to a more fluid continuum that leverages tools like adaptive designs and drives continuous drug development from Early Phases to Late Phases. Regulators support this shift, as long as sponsors present it persuasively.

What does this mean for the future of Early Phase clinical trials?

Topics for discussion:

• Tools that facilitate translational medicine
• Using adaptive designs in Early Phase trials
• How Early Phase trials will be conducted in the future
• How to position the “new” Early Phase trials with regulators