Phase out the waste.

While we’re on the subject, RILOMET-1 does more that halt the rilotumumab roll-out. It also serves as a broader indicator that we may need to re-evaluate our phase 2 design structure. We should all stop and ask ourselves: How were the survival outcomes so shockingly different between the phase 2 of 3 components? One big reason, it seems, is study design. Phase 3 trials often call for Herculean resources, not least of which are patients with rare diseases. Beyond the countless cost in health care dollars, an entire medical community must participate throughout a study era to ensure successful accrual for disease sites like gastric cancer. As such, we should demand a high positive predictive value from our phase 2 trials before entering into such a commitment. To the contrary, there has been a huge trend in oncology towards smaller Phase 2 trials prioritizing negative predictive values (i.e., ruling out sure-waste) with Big Pharma footing the bill. After all, high risks are called for with such high rewards. But while they may not be fazed by all the waste, we sure are.