Build a procedure-to-decision map
List each visit, assay, image and procedure and identify the safety or decision purpose it serves.
Count operational echoes
One procedure may also create site training, supplies, vendor integrations, monitoring, data cleaning and patient burden.
Challenge 'because trials usually do this'
Conventional practice can be appropriate, but habit alone is not a decision rationale.
Questions people actually ask
FAQ
Can exploratory endpoints be valuable?
Yes, when they have a clear hypothesis or future decision value.
Who should approve simplification?
The accountable clinical, statistical, regulatory and safety experts for the program.
Related
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