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.
The analysis also found that, across all phases of clinical trials, 43 percent of amendments occur before first patients are enrolled, with amendments more likely to occur in Phase I studies. And more than half of all protocols require one or more amendments, with the higher number occurring during Phase III, at 8.5. Also, one-third of all amendments involve protocol description and patient eligibility criteria, and the median total cycle time to identify and resolve a protocol problem is 61 days.
In commenting on the findings, Ken Getz, who is a senior research fellow at Tufts CSDD and runs the CenterWatch clinical trial resource, says in a statement that amending protocols is sometimes necessary, but drugmakers and clinical research organizations may be able to minimize changes and, therefore, save money by improving study design and patient recruitment.