Clinical trial practices: methodological and ethical aspects

ABSTRACT

The objective of this article is to review the methodology of controlled clinical trial, the protocol construction stages and their various ethical aspects. Controlled clinical trial is an experiment plant in which two contemporary groups of patients are compared in a forward-looking way, the first one is treated by the reference treatment [controlled group] and the other one if treated by the new treatment [tested group]. The allocation of treatments must be unpredictable and the follow-up of the patients makes blind with regard to the received treatment. These principles constitute the methodological frame of the controlled clinical trial which can not be approached under its only methodological or statistical angle. But also through an ethical serious reflexion worldwide especially with the fast progress of biologic sciences and medical techniques. In Morocco, the rule of the medicines is governed mainly by the Ministry of Health which has to assure security and the sanitary safety of the citizens. It is responsible for all the politics of medicines in Morocco and all their aspects. The realization of the bio equivalence and bio availability trials are two criteria which are darkened from the at present current texts. The accompanying measures of the implementation of these trials for example universal principles in person's protection, the Good Practices of Medicine's manufacture, the Good Clinical Practices, the Good Practices of Laboratory are not foreseen either by the current rule