Nearly 60 percent of all protocols used in clinical trials for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars, according to an analysis by the Tufts Center for the Study of Drug Development. Specifically, the review found that completed protocols across all clinical trials incurred an average of 2.3 amendments, and each required an average of 6.9 changes to the protocol. And the high rate of amendments is likely to persist, since the analysis found that the mean number of amendments was both positively and significantly correlated with a rising number of procedures per protocol, study length, and number of investigative sites participating in each trial.
