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Over the past several years, the number of deviations and substantial amendments made to clinical trial protocols has increased notably, contributing to delays in drug development and rising costs for completing studies, a new analysis finds.

From 2018 through March 2020 — before the pandemic disrupted research and development work — the average number of amendments for Phase 1, 2 and 3 trial protocols was 2.4, 2.7 and 3.3, respectively. By comparison, the number of amendments for each of the three trial phases was 1.8, 2.2, and 2.3 from 2013 through 2015, according to the Tufts Center for the Study of Drug Development.

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