Ethical Issues in Conducting Clinical Trials of Investigational Medicinal Products (CTIMP): Discussion

Abstract

This study appeared in full in the last issue of Research Ethics Review (2009; 5(1): 26). SB, a 21-year-old healthy male, volunteered to take part in a phase I randomized, double-blind, placebo-controlled drug interaction study. The trial compound was a CNS-active drug currently under development for a range of CNS indications. The trial–which was not ‘first in class’ or ‘first in man’ –comprised two residential seven-day study periods with a washout period in between. Three days after the end of the first study period the volunteer developed an acute, severe psychosis that warranted hospitalization.