An Investigator Is Conducting a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

An investigator is conducting a randomized, double-blind, placebo-controlled clinical trial of a new drug for the treatment of peripheral neuropathy in adults with multiple myeloma (MM) .  One hundred fifty patients with MM are enrolled in the trial and randomized to receive either the new drug (n = 75) or placebo (n = 75) .  Trial protocol requires that patients in both groups take 1 pill per day and keep a pain diary.  After 3 months of treatment, each patient is interviewed, and the pain diaries are reviewed; 9 patients taking the new drug and 3 patients taking placebo did not take the pills as instructed.  The investigator decides to conduct an intention-to-treat analysis of the study data.  Which of the following best describes how the data pertaining to all patients who did not adhere to protocol should be treated?

A) Conduct separate analyses of the 12 nonadherent patients and the 138 adherent patients
B) Exclude all 12 nonadherent patients from analysis
C) Exclude the 3 nonadherent patients in the group taking placebo from analysis
D) Exclude the 9 nonadherent patients in the group taking the new drug from analysis
E) Keep all 12 nonadherent patients in their respective groups for analysis

Correct Answer:

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