This study reviewed the clinical protocols for new drug development, approved by the ministry of Health and Social Affairs from 1994 to July, 1996, with respect to scientific integrity. 61 clinical protocols out of total 79 were reviewed.
The results concerning scientific integrity were summarized as follows :
Non-comparative studies were more frequent than comparative studies(59% : 36 cases vs 41% : 25 cases). The results indicated that statistical significance of comparative studies in clinical trials should be primarily recognized to improve scientific integrity.
Comparative study designs were classified into parallel design, cross over design and historical control design(22, 1 and 2 cases, respectively).
After the KGCP(Korean Good Clinical Practice) was implemented on 1 Oct. 1995, the number of comparative study design did not increase, but random allocation and blinding increased.
44.6%(25 cases) of the clinical protocols simply adopted the sample size described in the government regulation, while only 32.2%(18 cases) showed statistically reasonable sample size estimation method.
42.6%(26 cases) discussed the desicion criteria of patients inclusion for only safety evaluation and there was on change since the KGCP implementation.
Any statistical analysis plan was never mentioned in 24.6%(15 cases) and 16.4%(10 case) mentioned only descriptive analysis. The analysis plan was improper in 8.2%(5 case). And it was proper but described based on weak statistical concept in 34.4%(21 case).
Consequently, this indicated scientific integrity of clinical protocols is still not satisfactory yet but tends toward improvement since the KGCP implementation.
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