| The process of randomly assigning study participants to different treatment arms in a clinical trial is called randomization. In order to avoid a potential bias, the allocation is not performed by an investigator or a sponsor’s representative. An investigator who is convinced of the investigational drug’s effectiveness might (possibly unintentionally) assign certain patients to the treatment arm receiving the investigational drug if they have a higher potential of a positive treatment response. Randomization helps to avoid bias as patients are randomly assigned to the different treatment arms, receiving either the investigational drug or placebo/comparator. Such randomization systems are called IxRS (Interactive Voice Response Systems – IVRS, Interactive Web Response Systems – IWRS) and are either web-based or telephone-based systems. Randomized trials have the highest significance. |
Deutsche Erklärung |
