A drug trial using intention-to-treat (ITT) analysis includes in the final analysis:

• A Only patients who completed the full course of treatment
• B Only protocol-adherent patients (per-protocol analysis)
• C All randomized patients regardless of compliance or dropout ✓
• D Only patients with confirmed diagnosis at baseline

Explanation

Intention-to-treat (ITT) analysis includes all randomized participants in the group they were originally assigned to, regardless of compliance, dropout, or protocol deviations. This preserves the benefits of randomization, provides a conservative estimate of treatment effect closer to real-world effectiveness, and reduces risk of bias from selective dropout. Per-protocol analysis includes only adherent patients and may overestimate efficacy.

Reference: Park's Textbook of Preventive and Social Medicine, 27th ed.

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Written and medically reviewed by the StethoPrep medical team.