At the heart of a quality clinical design process is the availability of good information. Without the ability to access multiple sources of data, as well as the proper tools for integrating, objectively analyzing and modeling such data, then applying it to design, biopharmaceutical companies will remain challenged to improve the success rate of drug candidates.
One of the underlying tenets of “design thinking” is to integrate information to determine what is known, and more importantly, to determine the unknown (e.g., hypotheses, assumptions, risks). This allows the design effort to focus directly on addressing these unknowns, while minimizing the introduction of inadvertent bias.
For the most part, there are only two levers a company can pull to drive better outcomes: selection...