• The Korean Journal of Applied Statistics
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• v.22 no.2
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• pp.317-327
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• 2009

In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if not, it may cause bias. The international guidelines recommend the establishment of independent data monitoring committee for conducting interim analysis independently.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.181-186
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• 2016

Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

• Communications for Statistical Applications and Methods
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• v.5 no.2
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• pp.459-475
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• 1998

In many clinical trials, we are interested in comparing the failure time distribution of different treatment groups. Because of ethical and economic reasons, clinical trials need to be monitored for early dramatic benefits or potential harmful effects. Prior knowledge, evolving knowledge, statistical considerations, medical judgment and ethical principles are all involved in the decision to terminate a trial early, and thus the monitoring is usually carried out by an independent scientific committee. This paper reviews the recently proposed group sequential testing procedures for clinical trials with survival data. Design considerations of such clinical trials are also discussed. This paper compares the characteristics of each of these methods and provides the biostatisticians with the guidelines for choosing the appropriate group sequential methods in a given situation.

• The Journal of the Korea Contents Association
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• v.20 no.5
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• pp.204-211
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• 2020

This study investigates the 17 ordinances on the improvement of labor condition and status of social workers in the metropolitan city of Busan that has 16 administrative borough, or gu, and a central headquarter, and further verifies its implementation. Researchers identified the presence of 9 articles in each ordinances, followed by data request being made to all the administrative offices for their implementation. As a result, the articles on obligation, research on the actual condition, support plan and committee establishment have been excluded in many gus, which were in default of implementation or slower than ordinances stipulate. It is suggested that statements about the obligation of the head officers, preceding research on the actual condition before support plan and committee establishment should be made in the independent articles. Regarding its implementation, ordinances are required to have a regulatory power through penalty, reflect the actual demands of social workers in the field and go through a regular evaluation and monitoring on its implementation in order for purpose accomplishment.

• Health Policy and Management
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• v.34 no.2
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• pp.163-177
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• 2024

Background: This study aims to examine changes in fraudulent claim counts and total reimbursements before and after enhancements in counterfeit claim controls and monitoring of provider claim patterns under the "Proactive self-audit pilot program of fraudulent claims." Methods: This study used the claims data and hospital information (July 2021-February 2022) of the Health Insurance Review and Assessment Service. The data was collected from 1,129 hospitals assigned to the pilot program, selected from the providers who filed a claim for reimbursement for intravenous injections. Paired and independent t-tests, along with regression analysis, were utilized to analyze changing patterns and factors influencing claim behaviors. Results: This program led to a reduction in the number of fraudulent claims and the total amount of reimbursements across all levels of hospitals in the experimental groups (except for physicians below 40 years old). In the control group, general hospitals and hospitals demonstrated some significant decreases based on the duration since opening, while clinics showed significant reductions in specified subjects. Additionally, a notable increase was observed among male physicians over the age of 50 years. Overall, claims and reimbursements significantly declined after the intervention. Furthermore, a positive correlation was found between hospital opening duration and claim numbers, suggesting longer-established hospitals were more likely to file claims. Conclusion: The results indicate that the pilot program successfully encouraged providers to autonomously minimize fraudulent claims. Therefore, it is advised to extend further support, including promotional activities, training, seminars, and continuous monitoring, to nonparticipating hospitals to facilitate independent improvements in their claim practices.