The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
A.
Occurrence of known side effects of the IP
B.
Time to occurrence of symptoms of the disease
C.
Impact of an approved vaccine against the disease
D.
Use of concomitant medications to treat the symptoms
In a clinical trial aimed at assessing whether an IP prevents disease recurrence, the primary endpoint would typically be the "time to occurrence of symptoms" indicating a relapse or recurrence. This endpoint directly measures the IP’s effectiveness in prolonging the symptom-free period.
This answer follows the GCP guideline, which states that primary endpoints should directly reflect the trial's objectives, particularly when evaluating recurrence prevention.
"In trials evaluating recurrence prevention, the primary endpoint should measure the time until recurrence of the target symptoms or condition."
Objectives:
Assess the efficacy of IP in preventing disease recurrence.
Accurately measure the time to recurrence as a primary endpoint.
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