[Development of anti-cancer drugs under new renewed GCP--from the viewpoint of drug development company developer].
During the past 7 years since the enforcement of Japan's first GCP in October 1990, various standards and guidelines have been introduced in Japan. On the other hand, the harmonization of GCP has been the subject of major discussion at ICH in order to allow the mutual acceptance of clinical data from different countries. In order to further improve the reliability and consistency of clinical data and the ethics of clinical trials in Japan, the new GCP was enforced in April 1997. A clinical study is conducted by the sponsor, but will only be successful with the collaboration of trial subjects, medical institutions, heads of medical institutions, investigators, subinvestigators, pharmacists, nurses, laboratory technicians, and other assisting staff. Before the full enforcement of the new GCP, we, as sponsors of clinical trials, carried out a survey of the current status of clinical trials centering on the reactions of medical institutions to the new GCP, future of clinical trials on anti-cancer drugs in Japan, and differences in time from clinical trials to registration in Japan, the United State and Europe. We sent a questionnaire by facsimile to 21 pharmaceutical companies which have developed or are developing anti-cancer drugs and obtained replies from 20 companies (95%) from August 25 to 30, 1997. This paper reports issues concerning clinical trials on anti-cancer drugs based on the results of our survey.
Ueno
T
T
Late Stage Development Dept. III, Smith Kline Beecham Seiyaku, Tokyo, Japan.
Kobayashi
T
T
Inoue
K
K
Yanagi
Y
Y
Yamada
Y
Y
D000970:Antineoplastic Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000592:standards*; D004345:Drug Industry; D016903:Drug Monitoring; D006801:Humans; D007258:Informed Consent; D007564:Japan; D009369:Neoplasms / Q000188:drug therapy*; D017410:Practice Guidelines as Topic / Q000592:standards*; D011795:Surveys and Questionnaires
D000970:Antineoplastic Agents