Open Label Trial

Test trial design characteristics include type of trial, purpose, phase, and number of arms. They also include masking, allocation assignment, study endpoint classification, interventional model, enrollment numbers, eligibility criteria, and outcomes. In the category referred to as “masking,” a study is considered open or open label when the blinding process is not used. In other words, this design allows parties involved in the clinical trial to know which participant has been assigned to which intervention. Unblinding can include the investigator, the research subject, or even the outcomes assessor. An open trial means that there is no concealing of the true intervention in a randomized controlled trial from study participants, clinicians, and/or data assessors. Bias can occur in this type of design, especially when the outcome ...