ABSTRACT

Also called randomized consent design, this design was originally introduced to deal with some of the ethical problems facing clinicians as they enter patients into randomized clinical trials. For example, the patients in the control arm who receive standard treatment are not given the chance to be treated with the new treatment even if the new treatment is potentially better than the standard treatment, unless of course it is committed in the study protocol that the participants in the control arm will be given the chance to take the new treatment after the trial is over. Also, those allocated to the new treatment may want to opt for the standard treatment.