의료기관의 임상시험 현황과 활성화 방안: 2003년 연구와 비교를 중심으로

The Present State and Revitalization Plan for Clinical Trials in the Medical Institutions: A Comparison Study to the Year 2003

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.