In an open-label trial, both investigators and trial participants are fully aware of which treatment group the participants are in and what treatments are assigned to them. Open-label trials are used to compare different treatments or gather further information on the long-term effects of new drugs and treatments.
Full Answer
What is open label study?
Listen to pronunciation. (OH-pen LAY-bel STUH-dee) A type of study in which both the health providers and the patients are aware of the drug or treatment being given.
When would you use an open label study?
Open-label trials can be used to compare treatments or gather additional information about the long-term effects in the intended patient population.
What does open label treatment mean?
An open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants. In particular, both the researchers and participants know which treatment is being administered.
What is a multicentric study?
Definition. A multi-centric study is a study that is conducted at more than one research or medical center. The benefits of such studies include a large number of subjects from different geographic places and the ability to compare results from all of them.
Why is an open label study a limitation?
Compared with double-blind trials, the use of an open-label design may lead to exaggeration of the estimation of the risk of bleeding, venous thrombotic events and arterial thrombotic events with antiangiogenic treatment by 68%, 53% and 65%, respectively.
Can an open label study be blinded?
For open label studies, it's often desirable to blind the study sponsors to reduce potential bias and increase credibility of trial results. However, open label studies usually create some challenges to blind sponsors.
Are open label studies reliable?
Open-label extension studies do have a legitimate but limited place in the clinical development of new medicines.
What is an interventional study design?
Interventional study designs, also called experimental study designs, are those where the researcher intervenes at some point throughout the study.
What is a prospective multicenter study?
A clinical trial that is carried out at more than one medical institution.
What is single center study?
Single centre trials are usually set up in a particular hospital, clinic or general practice. They are usually small-scale studies, cheaper to conduct than multicentre trials and therefore generally easier to obtain funding for.
What is a prospective research study?
A prospective study, sometimes called a prospective cohort study, is a type of longitudinal study where researchers will follow and observe a group of subjects over a period of time to gather information and record the development of outcomes.