119. A critical situational review of a clinical trial protocol reveals that the primary outcome measure is difficult to assess consistently. What is the urgency for a biostatistician’s intervention?
A.
To proceed with the trial as is.
B.
To urgently recommend revising or replacing the outcome measure to ensure reliable and valid data collection, crucial for the integrity of the results.
✓
C.
To ignore measurement issues.
D.
To tell the clinicians to be more careful.
📖 Additional Information
To proceed with the trial as is.
To urgently recommend revising or replacing the outcome measure to ensure reliable and valid data collection, crucial for the integrity of the results.