The 2008 Drug Information Association (DIA) annual meeting featured a painful session on metrics in clinical trials. Not painful because of any of the speakers, who were polished and insightful. No, it was painful because sizable clinical research projects and sophisticated companies are not really being managed. We’re using the word “managed” in the sense that other…more...

The most notable nugget from the Center for Business Intelligence’s (CBI) Arlington, Virginia meeting on patient-reported outcome (PRO) research late last month was not so much from the podium, though there was plenty of excellent material there. Some of the most interesting news was in the questions from attendees. Your correspondent, for example, had assumed that utterances…more...

Earlier this month, after months of negotiations, Merck announced a large but manageable $4.85 billion settlement of an unknown number of Vioxx plaintiffs who can prove they took the drug and suffered strokes or heart attacks. Those plaintiffs still have to approve the deal. But it appears to be a watershed win for Merck, which had tenaciously…more...

The math of adaptive trials is hairy. But the appeal is simple. Adaptive trials can reveal the optimal dose in a single trial—not six. They can identify dud drugs early. The approach can require significantly smaller sample sizes and save big companies billions of dollars. There’s just one mathematical fly in the clinical ointment. Adaptive trials will,…more...