Small tests for big drugs?

From article "Merck Mess Shows FDA's Flaws" in TheStreet.com (a whole series is being published this week, see sidebar on page 1 of the article):

Prior to FDA approval, Psaty [an epidemiologist and drug-safety specialist who testified at the recent Senate hearings on drug approval] explained, Vioxx had been tested -- at common doses of 12.5 and 25 milligrams -- on just 371 patients for at least one year. The only large study to explore the drug's cardiac risks had yet to be completed.

As a medical informatics specialist used to designing EMR systems meant to capture clinical information on thousands or tens of thousands of patients (or more) routinely, the Clinical Trials and FDA approval processes seem like fossils from the 1950's.



Clearly, if medicine is to become more data-driven, industry and government can do far better than this.



It might help to clean out some of the deadwood that allow drugs for millions to be approved after tests in hundreds.



-- SS