Clinical drug trials require enormous commitments of money and time, and sponsors are understandably motivated to ensure they’re run efficiently. Late patient enrollment, delayed site activation, and missteps during the course of the trial are just some occurrences that can raise the already high stakes in developing new therapies.
So when we recently performed a double-blind trial of a treatment for major depressive disorder, the contract included bonuses — and corresponding penalties — tied to five factors: U.S. patient enrollment (40 percent), enrollment in Australia and Canada (7.5 percent each), database lock (30 percent), and first patient screened (10 percent).
When contract provisions like these started showing up a few years ago, they were generally an afterthought. Only recently have they started to become a standard part of the negotiation process, with risk-reward terms typically tied to milestones such as: