METHOD OF CONDUCTING AND INTERPRETING CLINICAL RESEARCH OF PRODUCTS (MOLECULES) ACTIVE IN RECEPTOR MECHANISM AS EXOGENOUS LIGANDS

摘要

The method of conducting and interpretation of clinical trials of investigational products (substances' molecules) operating in the receptor mechanism as exogenous ligands depends on the proper choise of statistical proofs, in which the trials are conducted, and on the proper succession of conducting the trials. At first, it is necessary to choose a statistical proof of people not exceeding 65 years because for such a proof it is possible to expect the efficiency of the investigational product. If a favourable outcome as to the safety of applying of the investigational product and its efficiency is acquired (even only in a subgroup of a given statistical proof), then one can continue the conducting of the trial of the investigational product to establish possible, usually contracted conditions of its efficiency among people over the previously established limit of age, and not exceeding 80 years. For the people over 80 years usually the efficiency of the investigational product should not be expected among the entire population but only in singular cases of the people biologically younger than their calendar age.