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Most clinical trial protocols amended during study

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Most clinical trial protocols amended during study

Nearly 60 percent 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.

An analysis, conducted by the Tufts Center for the Study of Drug Development, quantifying the impact of protocol changes on clinical trials, showed an average of 2.3 protocol amendments, with each requiring an average of 6.9 changes to the protocol, leading to significant unplanned expense and delay.

In the summary of the study, conducted in the September/October, Tufts CSDD Impact Report found that:

* Across all phases of clinical trials, 43% of protocol amendments occur before first patients are enrolled, with amendments more likely to occur in Phase I studies.

* More than half of all protocols require one or more amendments, with Phase III studies requiring the ‘highest number of changes per amendment at 8.5.

* One-third of all amendments relate to protocol description and patient eligibility criteria.

* Median total cycle time to identify and resolve a protocol problem is 61 days.

Source: http://csdd.tufts.edu/news/complete_story/pr_ir_sep-oct_2011