RANDOMIZED CONSENT DESIGNS IN CANCER CLINICAL-TRIALS

In 1977, Zelen proposed a new design for clinical trials with the aim of increasing recruitment by avoiding some of the problems associated with obtaining informed consent. These 'randomised consent' designs ha ve proved controversial, and have not often been used. This paper expl ains the statistical aspects of single and double randomised consent d esigns and reviews some of the ethical issues. All identified publishe d cancer treatment trials using a randomised consent design are consid ered in some detail. Reasons for and against the use of these designs are summarised.