Clinical Drug Trials Our Department
10.2185/jjrm.55.108
- Author:
Shoji KUMAKI
- Publication Type:Journal Article
- MeSH:
Clinical;
Performance;
Phase;
Pharmaceutical Preparations;
Acute Disease
- From:Journal of the Japanese Association of Rural Medicine
2006;55(2):108-111
- CountryJapan
- Language:Japanese
-
Abstract:
Our hospital began to deliver treatment of the sort which could well fall into line with the newly classified set of good clinical practices in June 1998, and our department began to provide in Norvember 1999. This report provides the results of a survey on the clinical drug trials we have since done. The number of clinical drug trials which had been done at our department before September 2005 and for which the period of registrationhad come to an end was 13. One hundred and sixty-one patients were contracted for clinical drug trials. Of them, consent was secured from 138 patients. The number of registered patients came to 125, and the rate of performance stood at 77.6%. A phase-specific comparison of this rate reveals that Phase II trials in the former period accounted for 25%, Phase II trials in the latter period 90.0%, Phase II/III trials 86.7% and trials for long-term asministration 81.3%. When the performance of clinical drug trials was compared in terms of rate on the basis of whether placebos were involved, the rate was 75.9% for six trials not including placebos and 78.5% for seven trials including placebos. For one trial for an acute disease, the rate was as low as 37.5%. The rate of performance was relatively high at our department, but when it comes to Phase II trials in the former period and trials for acute diseases, the rate of performance was low. The existenceor nonexistence of placebos did not affect the rates of performance.
