• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1994년도 교수 연수회(역학)
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• pp.270-284
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• 1994

Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately. the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. 'In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view. these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally. we discuss some important practical issues such as estimation following group sequential testing, anal ysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials. and the role of administrative analyses.

• 한국임상약학회지
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• 제26권2호
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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.

• 보건행정학회지
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• 제13권3호
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• pp.35-51
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• 2003

This study purports to develop a quality assessment tool for the process of health promotion programs at public health centers(PHC). The draft of the assessment tool developed by the literature was distributed to 242 staffs who were in charge of the health promotion programs at PHCs for evaluating the feasibility of the tool on September and October 2002. The major results of the study were as follows; The quality assessment tool developed in the study consisted of four domains: strategic planning, program management, monitoring and evaluation, and resources and information. The strategic planning dealt with the function of the planning staff and committees, community data analysis, the feasibility of the program, and the approach methods for attaining the goal of the program. The program management included the items on the qualification and power of the program staff. The monitoring and evaluation included the items on the reporting and communication among program units, and feed back after monitoring. Finally, the resources and information dealt with community networking, clients' response, and consulting activity of the staff. The validity of the tools was tested and partly supported by both formative and criterion-related methods. The assessment tools developed in this study could be used by health promotion workers in the self-evaluation of the program quality. In conclusion, the quality assessment tool developed in the study will be a good safeguard for assuring the quality of the process of health promotion programs.

• 보건교육건강증진학회지
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• 제21권2호
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• pp.1-16
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• 2004

The ultimate goal of health promotion programs is to improve the quality of life through promoting community health. Since the performance of health promotion programs are greatly affected by the quality of the planning and implementation process of the programs, the proper quality assessment of the program process is very important. According to existing literature, the tool for assessing the quality of the process and implementation as well as the outcome. However, no assessment tool for the quality of the process of health promotion programs has been developed in Korea. The purpose of the study is to develop a quality assessment tool for the process of health promotion programs being conducted at public health centers in Korea. The quality assessment tool developed in the study consists of the following four domains： strategic planning (14 items), program management (11 items), monitoring and evaluation (13 items), and resources and information (15 items). The strategic planning deals with the function of the planning staff and committees, community data analysis, the feasibility of the program, and the approach methods for attaining the goal of the program. The program management includes items on the qualification and power of the program staff. Monitoring and evaluation deals with the planning and education for monitoring, reporting and communication among program units, and feedback after monitoring. Finally, the resource and information covers the planning and activities for obtaining resources and information, community networking, beneficiaries' response, and consulting activity of the staff.

• 대한기관윤리심의기구협의회지
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• 제4권2호
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.