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OBJECTIVE: To strengthen the risk management in clinical drug trial so as to minimize the risk.METHODS: Based on modern risk management theory as well as the practical condition of the current clinical drug trial,an aggregate analysis was done and some opinions and suggestions were put forward.RESULTS: Under current model,it is objective and inevitable for the risks involved in clinical trial,but which could be reduced or avoided by taking some effective measures such as risk predication,standardization of clinical trial,ADR monitoring etc.CONCLUSION: There is risk in the drug clinical trial and it is necessary to conduct risk management.
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OBJECTIVE:To discuss the role of hospital pharmacists in the clinical drug trial.METHODS:The role of hospital pharmacists in publicizing and training of Good Clinical Practice(GCP),in the formulation of each standard operating instruction and in each stage of clinical drug trial was analyzed.RESULTS&CONCLUSION:Hospital pharmacists played a key role in clinical drug trial.They can get to know the basic research methodology from participating in the clinical drug trial,meanwhile their consciousness on scientific research can be strengthened.
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OBJECTIVE:To guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.ME- THODS:The basic principles,procedures and methods of ISO9001quality management standards were applied in the whole construction of clinical drug trial institution.RESULTS&CONCLUSION:The construction of clinical drug trial institution based on the ISO9001quality management standards was in conformity with the principle of Good Clinical Practice,which was helpful for the guarantee of the quality of clinical drug trial and the interests the subjects.
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OBJECTIVE: This investigation was performed to uncover the nature of the clinical drug trials in the past in Korean psychiatry and to prepare some guidelines for the good clinical practice in the future. METHOD: We reviewed total 212 papers of the clinical drug trials in the major Korean psychiatric journals from April 1962 to December 1998. RESULTS: From the year 1985, when the pharmacological and biological organizations in psychiatry were found in our country, the clinical drug trials are rapidly expanding. Although open clinical trials in small sample size less than 30 subjects were the most frequent in the past, some well-designed clinical trials such as multicenter double-blind cross-over study were performed recently. Majority of these 212 clinical trials was done in patients with schizophrenia and mood disorders. Haloperidol was just the drug most frequently evaluated in the clinical trials in our country. As expected, among several clinical rating scales, Brief Psychiatric Rating Scale was the most frequently used. Prolactin and homovanillic acid were the materials frequently measured in the patients with schizophrenia. A few of these clinical trials were performed under the financial supports from the industry, and only one biological research had gained a fund from a national academic institute. To evaluate the researchers' concepts for the medical ethics in the clinical drug trials, we reviewed the description about the informed consent and the approval of institutional review board in all papers. Surprisingly, we found no descriptions about the informed consent in 113 papers(65.8%). Only one clinical trial was performed after the approval of the institutional review board. CONCLUSIONS: We confirmed that the majority of the clinical psychiatric drug trials in the past were performed in lacks of the concept of Good Clinical Practice(GCP). The KGCP guideline did not influenced on the researchers' concepts and performance for the medical ethics at all. Although all of the clinical trials may not need to be done under the guidelines of GCP, clinical researchers' efforts for the medical ethics should be continued for both, the patient and the researcher.