New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance

Kenneth Getz,Zachary Smith,Emily Botto, Elisabeth Murphy, Arnaud Dauchy

Research Square (Research Square)（2024）

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摘要

The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a follow-up study in 2022 to assess trends in protocol amendment experiences and the impact amendments have had on clinical trial performance, particularly during the COVID-19 pandemic. Sixteen pharmaceutical companies and contract research organizations provided data on 950 protocols and 2188 amendments. The results show that, since 2015, the prevalence of protocols with at least one amendment in phases I–IV has increased substantially (from 57 to 76

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关键词

Protocol amendments,Protocol design,Protocol complexity,Protocol optimization,Clinical trial execution

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