title: [Early clinical trials in ECTG. Early Clinical Trial Group].
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.
authors.affiliation: Aichi Cancer Center, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Ogawa
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects; D017321:Clinical Trials, Phase I as Topic / Q000379:methods; D004354:Drug Screening Assays, Antitumor; D005060:Europe; D006801:Humans; D007564:Japan; D015337:Multicenter Studies as Topic / Q000379:methods
chemical_list: D000970:Antineoplastic Agents