Related Experiment Video
Updated: Jun 11, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
[Early clinical trials in ECTG. Early Clinical Trial Group]
1Aichi Cancer Center, Japan.
Abstract:
Methodology to conduct phase I trials in the Early Clinical Trial Group (ECTG) in Europe was reviewed and compared with current status of the trials in Japan. Single dose acute toxicity studies and repeated dose toxicity studies were required in order to enter phase I trials in Europe, while in Japan those results and various other toxicity studies such as mutagenecity, carcinogenecity and reproductive toxicity were required. Since significant numbers of new anticancer drugs are dropped in the early stage of clinical investigations, it is recommended that unnecessary toxicological studies be avoided. Repeated administration and dose escalations in the same patients are allowed during phase I trials in ECTG, partly in consideration of the patient's desire to obtain antitumor effects. Dose intensity and quality of life are considered in order to decide the optimal dose and schedule in phase II trials.
More Related Videos
10:01High-Throughput Optical Controlling and Recording Calcium Signal in iPSC-Derived Cardiomyocytes for Toxicity Testing and Phenotypic Drug Screening
Published on: March 31, 2022
14:03High-Throughput Cardiotoxicity Screening Using Mature Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Monolayers
Published on: March 24, 2023
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Preclinical Development: Overview
Electroconvulsive Therapy