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Background: According to the economic prosperity, the Korean pharmaceutical market is growing fast accompanied by the increment of the multinational clinical trial studies. Under these circumstances, lots of promotional policies and plans have been enforced by the Korean government specifically through a project name as 'Strategy Development for the Establishment of Infrastructure and Promotion of Clinical Studies in Korea' in 2003. In regard to evaluate the efficacy of the project and the extent of the accomplishment, we performed a follow-up study in comparison to the year 2003. Methods: The study was performed for 6 months at the qualified, ninety-nine medical institutions. Specific information was gathered by surveys or data-collections to investigate the correlations among facilities, staffs, and education programs if any changes happened during the study period. Also, the study was designed to understand if there is any improvement on infrastructures after initiating the government's plan. All the data were processed by a statistical program for the analyses of the rank, frequency, and the relationship between the variables. Results: The average response rate was 77.8% and revealed that the number of workforce was increased associated with the promotional policies of the government. However, the scarcity of both allocated-time and trained professionals for the clinical studies as well as the inadequate level of facilities were selected as the most troublesome factors in participating the multinational study projects. Conclusion: The follow-up study reveals that all institutions were successful to enlarge their capabilities when focusing their resources on the infrastructures in accordance with the governmental enforcements. In addition, we suggest that the remaining problems could be diminished through fast decisions on investments, correcting actions on imbalances, complementary measures on the governmental activities.
Background: The number of clinical trials which have been performed within Korea is increasing accompanied by the enlargement of the various responsibilities of each Institutional Review Board (IRB) in the way of providing adequate and on-time managerial involvements on the studies. Many confounding factors of each study can influence on the results with which delaying the final reports, or extending the review times associated with research-periods, or adjusting the alterations. Even though these factors were closely related to the results being managed by the IRBs, no in-depth research have been implemented to elucidate the correlations between these factors and the results necessitates IRBs' managements. Methods: Study subjects were selected and analyzed retrospectively in a University hospital's database. About 190 study projects which had been completed during 2005 to 2007 were retrieved and the characterized factors were classified into seven categories. Each category was analyzed and tested statistically by SAS program. Results: It is revealed that a large portion of the factors was subjected to the study profiles. The review-time showed extended tendency in the subjects which used medications (P=0.0174) required approval (P=0.0009) in phases I II III (P<0.0001) initiated by sponsors (P<0.0001) and with duration of 1 to 2 years (P=0.0442). Prior to submitting IRB, correction-times were multiplied specifically on the study subjects that used medications (P<0.0001) required approvals (P<0.0001), underwent phase I II III (P<0.0001) reviewed twice (P=0.0074) initiated by sponsors (P<0.0001) exceeded 2 years of period (P<0.0001) and required modifications before the submission (P=0.0001). Conclusion: The clinical study projects characterize by 'medication-used', 'sponsor-initiated', 'approval-required', 'duration period of 1 to 2 years', and 'under phase I II III' required thorough concerns and investigations from the beginning stage to reduce the time of review by the IRBs. Studies lasted more than 2 years entailed preparation of the sudden alterations to prevent the study duration. A new further study is necessary to analyze the frequency and the causes of the alterations in the study proposals.