Clinical Trials Labeled as “Negative”

Henry Miller writes in this latest article on Forbes.com that when unfavorable findings in clinical trials are deemed as “negative”, the term itself has a very different meaning from the common usage.

To anyone who is not familiar with clinical trials, it might seem as if a “negative” clinical trial went haywire and that the testing was detrimental to patients. Henry assures that clinical trials are very seldom negative in that sense. What negative really means is that the tested drug was not helpful for the applicable uses for which regulatory approval is being sought.

There can be several reasons why these drugs were labeled negative. Henry provides these: The reasons can include insufficient statistical power (number of patients) in the study; inappropriate choice of dose, frequency of administration, or stratification (grouping) of subjects; or simply the drug's failure to be effective for the purpose for which it was tried.