Host: The Japanese Society of Toxicology
Name : The 47th Annual Meeting of the Japanese Society of Toxicology
Date : 2020 -
Although non-clinical data are extremely important when performing clinical trials in early stage to secure subjects’ safety, the amounts of information are limited especially in a first in human trial. Investigators will try to get meaningful information from Investigator’s Brochures (IB), and it is not an easy task. We must recall a tragedy of sacrifices in an FIH study performed in France. The IB of the case was insufficient and included many mistakes of table and figures and mistranslation. Generally, IBs, we read, are correct in scientific meaning, but hard to read owing to too correct and too complicated explanations by specialist in the field. The tendency is especially remarkable when studies were done by outsourcing. Investigators are making every effort in securing subjects’ safety and preclinical data are the only direct information of candidate compounds. Investigators will face subjects living their daily lives who should not be harmed. I hope toxicologists to understand the importance of data and to transfer useful information to investigators.
