Tufts CSDD has released the latest version of its bi-monthly Impact Report. In this January/February 2022 edition, the focus is on an issue that has plagued the pharmaceutical industry for years: the incidence of protocol deviations and amendments in clinical trials. While these hurdles are both at new highs across all phases, they have been steadily increasing since the start of the COVID-19 pandemic.
From the results a new Tufts CSDD analysis conducted in 2020, some of the highlights in the report are:
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Actual timelines for protocols with three or more substantial amendments are nearly three weeks longer than planned treatment durations.
In a typical Phase III trial, 119 protocol deviations, on average, are implemented, involving approximately one-third of all patients participating in that trial.
