Keeping Score, Clinical Watchdogs Push Drugmakers For More Open Data | Xconomy
"Should drug companies publicly release all data from the tests they conduct on human volunteers? A growing number of parties say yes, and last week, a group of academics unveiled a scorecard to spotlight companies that have recently kept their clinical data hidden from public view—and those that have made the data available. As with all shorthand systems that boil down complicated scenarios, the clinical trial scorecard, developed at New York University, Harvard University, and Yale University, requires explanation. I’ll get to that. But what struck me like a bolt was the organizing principle of the report’s authors. It was simple, perhaps even unassailable: In exchange for the privilege of testing for-profit drugs on human subjects, companies have an obligation to make all their clinical data available for the common good. Science and medicine should work best when research can be examined, criticized, and serve as a foundation for more studies ... Miller, who said she has been working on the project for six years, expects her scorecard to become an annual tally, but last week’s release in the journal BMJ Open started with a small sample size. She and her team assessed 318 trials used to test 15 drugs, all approved by the FDA in 2012. This is a subset of all new drugs approved that year; the authors decided to investigate only drugs brought to market by large companies. With their size and financial muscle to put behind the transparency requirements, 'if anyone would score well, it would be [them],' said Miller. Not all scored well ..."