The German edition of this manual appeared in 1979. Its main objective then was to extend help to those engaged in multiaentric therapeutic studies, especially with respect to the "Federal Government's Program on Promoting Research and Development in the Service of Health." Experience with therapeutic studies in the Federal Republic of Germany showed that considerable problems as to methods and implementation of such studies exist. The manual was an attempt to present current metho- dological knowledge and the experience obtained from completed studies in the light of the international...