Current status of the development of antimicrobial agents after enforcement of the new GCP.
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Accession number;00A0593237
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| Title;Current status of the development of antimicrobial agents after enforcement of the new GCP. |
| Author;
SAITO ATSUSHI
(Jikei Univ. School of Medicine)
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Journal Title;Japanese Journal of Chemotherapy
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Journal Code:F0608A
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ISSN:1340-7007
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VOL.48;NO.5;PAGE.319-324(2000)
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| Figure&Table&Reference;FIG.4, REF.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Clinical trials are conducted to finally demonstrate the efficacy and safety of new agents in humans. The results of these trials a extremely important for evaluating new agents. Therefore, clinical trials. should be conducted based on an ethical consideration, and the results must be scientific and reliable. In October 1989, the Good Clinical Practice(GCP) was published as the standard for conducting clinical trials. GCP has been completely enforced since October 1990 (previous GCP). However, according to some investigators, the level of clinical trials in Japan has not yet reached that in the United States and Europe. To further improve the quality of clinical trials in Japan, the human rights of subjects should be protected, and safety and data reliability should be ensured. In May 1996, the final agreement among Japan, the United States, and Europe (ICH-GCP) was obtained at the International Conference on Harmonization(ICH). Enforcement of GCP in Japan at the international level was required. In March 1997, the new GCP was established. In April 1998, it was completely enforced. The new GCP was prepared to establish compliance matters with respect to planning, monitoring conducting surveillance, maintaining records, analyzing, and reporting clinical trials, which are conducted to collect materials for new drug application for manufacturing, and to ensure the scientific quality of clinical trials and data reliability, while protecting the human rights of subjects, safety and welfare. Concerning the influence of the new GCP on the development of antimicrobial agents, the interval after complete enforcement is still short, and future tendencies must be carefully examined. However, pharmaceutical companies and medical institutions are trying to make internal changes to meet the new GCP, and are developing an efficient operating method. In Japan, clinical trials of new drugs may be delayed in the near future.... (author abst.) |
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