The need to speed and improve clinical trials is a hot topic, but making that happen isn’t, of course, so easy. A few days ago, Bio-IT World spoke with Wyeth’s Mike Krams, who also spent a decade at Pfizer, about the issues. Here are excerpts:

Bio-IT: At what point in drug development should adaptive trial designs be deployed?

Krams: Adaptive trial designs can be deployed from the very beginning of clinical drug development: Phase I - continuous reassessment - across Phase II - response adaptive dose-ranging studies - to confirmatory Phase III trials - i.e., blinded sample size re-estimation, group sequential designs, maybe even seamless Phase II/III.

Bio-IT: How would you characterize the pharma industry’s overall take on adaptive trials circa 2007?

Krams: Ten years ago I would have said it was a fringe thing. Today there is considerable interest across the industry, but the industry is divided into three parts: those who will never touch it, those who want to sit back and observe, and those who are ready to bite the bullet.

Complete interview here:
Part One and Part Two.
And here’s a primer on adaptive trials by Derek Lowe.[tags]Clinical Trials[/tags]