Definition: An open-label study is one in which both the health providers and the patients know which drug or treatment is being given. The NCI says it is also called nonblinded. Labels often report an open-label extension, where people keep taking the drug after the blinded part of a trial ends.
| Label | What the label reports |
|---|---|
| AndroGel 1.62% | Skin reactions at the application site in 2 of 234 men (0.9%) in the double-blind period and 3 of 219 (1.4%) in the open-label period that followed |
| Azmiro | A randomized, single-dose, open-label study in 27 men compared with another testosterone shot; no placebo group |
| Cialis | In the 1-year open-label extension, back pain in 5.5% and muscle aches in 1.3% |
| Crinone | Its side-effect tables come from open-label studies |
Without a hidden comparison group, there is no placebo column to set the numbers against. The FDA labeling rule (21 CFR 201.57) says that when comparison rates cannot be reliably worked out, for example when reactions were seen only in the uncontrolled part of a trial, they are grouped into frequency ranges or described in words.
An open-label extension often runs longer than the blinded part, so it is where labels report what happened over a year or more. Your own long-run log is open-label by nature: you know what you take, and the value is in the dates.
Read more on Dose Track: AndroGel side effects · Azmiro side effects · Cialis side effects · Crinone side effects