• 대한임상약리학회:학술대회논문집
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• 1994.12a
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• pp.13-13
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• 1994

• 대한임상약리학회:학술대회논문집
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• 1994.12a
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• pp.15-15
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• 1994

• The Journal of the Korea Contents Association
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• v.11 no.1
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• pp.350-356
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• 2011

The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.

• Journal of Gastric Cancer
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• v.5 no.2
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• pp.79-88
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• 2005

Quality assurance may be defined as the complete set of systemic actions that is required to achieve a better treatment result by standardizing treatment and by using various audit programs. In general, application of a quality assurance program in surgery is considered to be more difficult than it is in chemotherapy or radiotherapy. However, recently, the importance of quality assurance in the surgical field has been emphasized in clinical trials comparing different surgical procedures and evaluating the role of postoperative adjuvant therapy. In the case of gastric cancer surgery, excellent quality assurance programs have rarely been applied in most large prospective clinical trials. Although the quality assurance in Dutch trial was conducted very systemically and strictly, the situation is quite different from ours. On the other hand, several quality assurance programs in Japanese trials comparing D2 and D2 plus para-arotic lymph node dissection seem to be applicable to Korean clinical trials. Several factors, including selection of appropriate surgeons based on personal experience and annual number of operations, standardization of surgical procedures by education and consensus, development of a unified database program, application of standardized perioperative management, and standardization of pathologic examination, are required to guarantee a successful multi-institutional prospective clinical trial. In contrast, one needs to realize that protocols that are too strict and sophisticated can make the enrollment of patients and surgeons more difficult and can promote protocol violation during the clinical trials. (J Korean Gastric Cancer Assoc 2005;5:79-88)

• The Korean Journal of Applied Statistics
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• v.28 no.6
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• pp.1209-1216
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• 2015

Competing-risks events are often observed in a clustered clinical study such as a multi-center clinical trial. We propose a joint modelling approach via a shared frailty term for competing risks survival data from a cluster. For the inference we use the hierarchical likelihood (or h-likelihood), which avoids an intractable integration. We derive the corresponding h-likelihood procedure. The proposed method is illustrated via the analysis of a practical data set.

• 대한예방의학회:학술대회논문집
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• 2001.10a
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• pp.302-304
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• 2001

• Journal of the Korean Data and Information Science Society
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• v.27 no.2
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• pp.499-510
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• 2016

It is very important to select relevant variables in regression models for survival analysis. In this paper, we introduce a penalized variable-selection procedure in multi-level frailty models based on the "frailtyHL" R package (Ha et al., 2012). Here, the estimation procedure of models is based on the penalized hierarchical likelihood, and three penalty functions (LASSO, SCAD and HL) are considered. The proposed methods are illustrated with multi-country/multi-center bladder cancer survival data from the EORTC in Belgium. We compare the results of three variable-selection methods and discuss their advantages and disadvantages. In particular, the results of data analysis showed that the SCAD and HL methods select well important variables than in the LASSO method.

• 대한임상약리학회:학술대회논문집
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• 2001.12a
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• pp.24-25
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• 2001

• 대한예방의학회:학술대회논문집
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• 2001.10a
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• pp.305-307
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• 2001

• Korean Journal of Acupuncture
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• v.24 no.3
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.