The Secrets of a Successful Clinical Trial: Compliance, Compliance, and Compliance
aMedication Compliance in a Phase 1b Safety and Tolerability Study
| Compliance (percent of visits) | Number of subjects | Mean compliance (percent of visits) |
|---|---|---|
| 0 | 3 | 68 |
| 25 | 2 | |
| 50 | 2 | |
| 75 | 7 | |
| 100 | 9 | |
| Total = 23 |
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↵a In a double-blind, outpatient study, subjects were instructed to take capsules containing either study drug or placebo twice daily. Blood was drawn from all subjects at weeks 2,4, 6, and 8. Among the 31 subjects randomized to the active arm, 23 completed the trial. The detection of drug in the blood during the given visit was scored as evidence of compliance for that week. 100% compliance indicates the detection of drug in the blood (> 3 ng/ml) in 4 out of 4 visits. 0% compliance indicates the detection of drug in none of 4 visits.
