a1 Department of Epidemiology and Population Sciences, London School of Hygiene and Tropical Medicine, WHO, Geneva
a2 Special Programme for Research and Training in Tropical Diseases, WHO, Geneva
The randomized controlled trial has become the standard basis for the evaluation of new therapeutic agents and procedures (and for measuring the protective efficacy of new vaccines or for assessing the value of screening procedures). Patients, who have met the criteria for eligibility and have agreed to participate in the trial, are allocated on a random basis to the alternative therapies under consideration. In order to avoid possible bias in the handling or assessment of these groups, a double blind procedure is preferred; the therapy given is not known to those who administer it, to those who assess the course of the disease thereafter, nor to the patients themselves. There is an extensive literature on clinical trials covering their logic and history, modern developments and the many complex, often controversial, issues that such trials have provoked. Not all issues have been fully resolved but by and large the principle, the practice and the ethical concerns of clinical trials are worked out and firmly established.