Topic: Interim Reviews

Amnesty for Reluctant Early Stoppers in Clinical Development

In the C-Suite, virtually all biopharma companies insist on failing unsuccessful candidates faster and reallocating resources to more promising molecules. This is only rational. But the industry has a dirty little secret. This isn’t the kind of secret that stays within the confines of the C-Suite. It’s the kind that never bubbles up that high…. Read more »

Faster to Market, Faster to Fail

The team at Health Decisions enjoys nothing more than helping a sponsor bring a successful product to market months or years ahead of schedule. Through a combination of adaptive design and adaptive operations, we have succeeded in accelerating market entry for many products, sometimes by more than two years, as in the case of one… Read more »

DSMBs and Business Decisions in Clinical Research

Interim reviews in clinical trials have always been controversial in some circles because they require somebody to look at otherwise confidential data while a trial is in progress, raising the possibility of introducing bias. On the other hand, not letting anybody see interim data is a great way to have a trial with serious issues… Read more »