Protocol Amendment Storytelling

Background

There is a hypothetical Phase III clinical trial for a chronic disease. During study conduct, recruitment is slower than anticipated. A major protocol amendment is introduced at Month 10 to relax eligibility criteria, reduce visit frequency and simplify data collection requirements.

The challenge

The sponsor would like to understand whether the amendment successfully improved trial performance.

Create a data visualisation that clearly communicates any of the following (or any other ‘story’ you find interesting to convey to the sponsor):

• What changed after the amendment
• Whether recruitment improved
• Whether operational efficiency improved
• Any trade-offs or unintended consequences

The data

24 months of study conduct (amendment introduced at Month 10). The dataset includes the following variables:

Variable Name	Variable Label
Month	study month (1-24)
Amendment_Status	Before/After Amendment (indicator)
New_Subjects_Enrolled	Number of subjects enrolled during the month
Screen_Failure_Rate	Percentage of screened subjects failing eligibility criteria
Active_Sites	Number of sites actively recruiting
Protocol_Deviations	Number of protocol deviations recorded
Avg_Query_Days	Average time (days) to resolve data queries
Avg_Visit_Burden	Mean scheduled visits per patient
Retention_Rate	Percentage of randomised subjects remaining in follow-up
Monitoring_Cost_GBP	Estimated monitoring expenditure (£)

The data is provided in Excel format.