By Dr. Esha Senchaudhuri
When Cyrus Mehta introduced the Promising Zone Design over a decade ago, the new statistical method not only transformed the allocation of scarce resources within a clinical trial setting but also the design reconceptualized how sponsors could increase investment in their trials. By specifying various eventualities that could occur during an interim look, potential investors were better positioned to tie their investment strategy to the financial risk profile of the success of the new medicine or biologic. This ensured that risks taken by investors reflected expected gains.
Since the introduction of the promising zone, the propulsion of simulation technology and the power of new forecasting engines has generated even more methods to align clinical development with financial strategy.