One-third of changes to clinical trial protocols are avoidable, says Tufts CSDD

Nearly 60% of all protocols used in clinical trials for new drugs are amended during the trial. Moreover, one-third of those changes could have been avoided, according to the first-ever analysis, conducted by the Tufts Center for the Study of Drug Development, quantifying the impact of protocol changes on clinical trials.

Completed protocols across all clinical trials incur an average of 2.3 amendments, with each requiring an average of 6.9 changes to the protocol, leading to significant unplanned expense and delay, says Tufts CSDD. Until now the incidence, causes, and impact of protocol amendments have never been systematically quantified across the pharmaceutical and biotechnology industry. A protocol is a plan detailing the methodology of a clinical trial.

Changes can be minimized