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"Protocol Amendments: Understanding the True Cost and Impact"

With 76% of Phase I-IV trials now requiring amendments--up from 57% in 2015--protocol changes have become one of the most significant drivers of trial delays and budget overruns. Each amendment costs between $141,000 and $535,000 in direct costs alone, taking an average of 260 days to implement.

The challenge compounds in complex trials: 90% of oncology programs require at least one amendment, with sites operating under different protocol versions for an average of 215 days—creating compliance risks and operational complexity.

This infographic reveals:

• The hidden cascade of costs beyond the initial amendment price tag
• Why 1 in 4 amendments are avoidable with better initial planning
• Specific examples of necessary vs. avoidable protocol changes
• Four prevention strategies that reduce amendment frequency and impact

There is a clear pattern in the data showing that teams who engage stakeholders early, bundle changes strategically, and use structured decision frameworks experience fewer amendments and shorter implementation timelines.

Based on current industry benchmarks and Precision's experience helping sponsors move from reactive amendments to proactive protocol planning.

See the data that can help prevent avoidable amendments in your trials.

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