Are international clinical trials regulated? By the FDA? By anyone? In gentle language, the U.S. Department of Human Services says that one of its own fiefdoms, the FDA, has been unable to keep up with the rapid growth in clinical research outside America. The push to find clinical trial patients outside the U.S. is not news. But…more...

This reporter is always disheartened when lawyers are ridiculed. Lately, we've been saddened by the news that a few law schools, just trying to help graduates find employment, have unilaterally granted all their students better grades. A formula here, a few computer key strokes there—and bingo! All of the lawyers just got smarter. Elastic metrics are not…more...

While it supports a cottage industry of professionals, manually pushing piles of clinical trial data along from one system to the next isn't necessarily the most efficient way of doing things. The same company may map data for the same drug in different ways in different trials—or miss errors in one trial's data set that were fixed…more...

One notable aspect of media coverage of clinical trials is the ready acceptance of the cost of a particular clinical research program. In every notable publication, as far as we can tell, the cost of a trial or a research program is confidently said to be so many tens or hundreds of millions of dollars. The amount…more...