Open-label trial
Open-label trial
An Open-label trial (pronunciation: /ˈoʊpən leɪbəl traɪəl/) is a type of clinical trial in which both the researchers and participants are aware of the drug or treatment being administered. This is in contrast to a double-blind trial, where neither the researchers nor the participants know what treatment is being given.
Etymology
The term "open-label" comes from the fact that the "label" of the drug or treatment being given is "open" or known to all involved. The term "trial" is derived from the Latin word "trialis" meaning "of three", referring to the three stages of clinical trials.
Procedure
In an open-label trial, all parties involved are aware of the treatment or drug being administered. This includes the researchers, participants, and often times the statistical analyst as well. The purpose of an open-label trial is to provide real-world evidence of a drug or treatment's effectiveness. It is often used when it is considered unethical to withhold treatment from a control group, or when the effects of the treatment are obvious and cannot be hidden.
Advantages and Disadvantages
The main advantage of an open-label trial is that it can provide more realistic results, as it reflects how the treatment would be used in the real world. However, it also has several disadvantages. The main disadvantage is the potential for bias, as knowing the treatment being given can influence the behavior of both the researchers and participants. This can lead to skewed results.
Related Terms
See Also
External links
- Medical encyclopedia article on Open-label trial
- Wikipedia's article - Open-label trial
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