According to a new study, almost 60% of clinical trial protocols for
new drugs are amended during the trial, but one-third of those changes
could have been avoided. This is according to a new study from the Tufts
Center for the Study of Drug Development (CSDD) released this week.
Tufts researchers found that 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. “Although amendments to protocols of clinical trials
are sometimes necessary to optimize study results and ensure patient
safety and ethical treatment, study sponsors can minimize the number of
protocols through better initial study design and improved recruitment
of study volunteers,” said Ken Getz, Tufts CSDD senior research fellow
and assistant professor at Tufts, who led the study.
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