Reinventing Clinical Trial Design: Digital Development

By Albert Kim

New medicines and devices under development live and die on the strength of their clinical data. An asset’s journey is long and difficult—from assessing tolerability in a first in human study, to proof of pharmacodynamic activity, to proof of clinical activity, to pivotal confirmatory trials for safety and efficacy. At every stage, the data readout from a clinical trial is highly visible for teams, companies, and their investors, and can make or break the project. In this context, planning the right trial is an immensely important endeavor, and integrating strategy and efficient statistical tactics (i.e., intelligent design) even more so. Are your designs and studies the best they can be?

Clinical development professionals are faced with many questions to answer and problems to solve during the product development expedition.  What clinical trial design will provide the right answers at the right time? How can it be accomplished quickly and economically?