Article | June 16, 2021

CSDD Report: Mid-Study Changes Cause Long Delays

Source: Medrio
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Planned and unplanned mid-study changes add an average of 30 days to clinical trial timelines, according to a new study by the Tufts Center for the Study of Drug Development (CSDD).1 The findings, based on data collected from 194 global drug developers, found that regardless of company size, each clinical trial has an average of four planned and four unplanned mid-study updates.

Further analysis found that larger companies take an average of 35 to 40 days to resume a trial after a mid-study change. Smaller companies reported delays closer to 25 days.

Ken Getz, professor, and director of Tufts CSDD who oversaw the study weighed in, “Sponsor companies are seeing an increase in mid-study updates as they implement more amendments, conduct more interim analyses, and execute more flexible and ambitious clinical trial designs. The study demonstrates the challenge and impact of planned and unplanned updates and suggests an important opportunity to reduce clinical trial cycle times.”

This blog highlights more findings from this survey and expert insights on how to overcome the challenges of mid-study changes.


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