Methodology to minimize bias in open-label trials

7 METHODOLOGY TO MINIMIZE BIAS IN OPEN-LABEL TRIALS 

In some situations double-blind placebo-controlled trials are not acceptable from an ethical standpoint examples are studies on patients in life-threatening conditions such as severe withdrawal symptoms (e.g. delirium tremens) or diseases with a high risk of suicide. To keep double-blind conditions in longterm treatment may also be difficult or even impossible, e.g. if one of the drugs used needs special safety monitoring or if the side-effect profile requires special treatment considerations. 

In this situation the use of trial-independent, blinded raters assessing the primary endpoints of a study can ensure unbiased ratings, although it will not eliminate other confounding factors operating during a trial. 

Independent blinded raters are health professionals from a different department or from outside, with no information about details of the treatment studied. Their involvement in the trial is limited to providing ratings for the primary study endpoint(s). 

Independent Midpoint committees are groups of experts who. based on blinded and standardized reports, decide whether specific event(s) reported for a patient meet the criteria of a defined primary Midpoint. Examples of endpoints are imminent need of hospitalization, suicide attempt, etc. (see Box 5.7). 

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