• 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.

• The Journal of the Korea Contents Association
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• v.13 no.4
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• pp.281-289
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• 2013

As the number of clinical trials conducted in Korea increases, the need of the Electronic Data Capture (EDC) system for effective clinical data management is also increased. Recently, the Korea Food and Drug Association published 'Guideline for the Electronic Clinical Trial Data Management and Processing' and it would be the foundation for establishing regulation of electronic clinical data management. In this research, we conducted the survey regarding adoption rate of EDC system in clinical trials in hospitals, Contract Research Organizations (CRO), and pharmaceutical companies. And the perceived importance and the ease of application for the Guideline were investigated. The adoption rates of EDC system was 77.6% but it mostly applied to less than five trials. Also EDC system was mostly used in phase I and phase II trials and the utilization rate of CRO was the highest. The perceived importance for the Guideline was high among all three organizations but, in case of the perceived ease of its application, CRO was the highest. Also, the perceived importance of the clinical data standard was high and the standard for data collection was mostly required. However, the comprehension for the global standard of the electronic data was relatively low, so that education is required. This result would be the foundation to increase the electronic clinical trials and develop proper regulation and principles for clinical data standards in Korea.

• Korean Journal of Acupuncture
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• v.28 no.3
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• pp.177-186
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• 2011

Objectives : The aim of this study is to review clinical trials using Qigong exercise on patients with hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of Qigong exercise were performed in 21 electronic databases (5 international databases and 16 Korean databases). English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of 11 studies met the inclusion criteria. Five randomized controlled trials, Four non-randomized trials and two before-after studies were included. Seven studies used self-developed Qigong exercise. Two studies used Guolin Qigong exercise and two studies used Qigong exercise with an anti-hypertension drug. Of the nine randomized trials or non-randomized trials, four studies used an anti-hypertension drug control and three studies used waiting list controls. Compared to baseline, a change in blood pressure after the Qigong exercise treatment was significant in all studies. However, the results effect of blood pressure between Qigong exercise and controlled trials were not consistent. Conclusions : There are low-quality clinical trials of Qigong exercise for hypertension. To evaluate the effects of Qigong exercise, more rigorous trials are warranted.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.30 no.3
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• pp.76-87
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• 2017

Objectives : This study aimed to analyze the recent acupuncture clinical trial on atopic dermatitis and to suggest the plan about how to improve its quality. Methods : Data were collected through electronic database including MEDLINE. We set up the search terms for "atopic dermatitis AND acupuncture" and limited period of data within 6 years and type for RCT(Randomized Clinical Trial), SR(Systemic Review). Results : Total 5 studies were selected. Two were RCTs, and the rest were SRs. RCTs were insufficient about acupoint selection criteria and foundation. SRs both pointed out that systematic clinical trial is required. Conclusions : Based on these, we suggested the plan as follows. 1. Selection criteria - We should reevalute the participants by using diagnostic criteria and scales. 2. Selection acupoints - We should present the foundation that why we choose these acupoints. 3. Establishing acupuncture and control group - We should make control group clearly after calculating the number of participants statistically. 4. Blinding - We should propse the method, type, procedure and evaluation about randomization. 5. Evaluation scale - We should select the suitable scales for research objectives.

• Journal of Acupuncture Research
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• v.28 no.5
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• pp.87-96
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• 2011

Objectives : The aim of this study is to review clinical trials using moxibustion on hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of moxibustion were performed in nine electronic databases (four international databases and five Korean databases) and handsearch. English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of twelve studies met the inclusion criteria. Seven randomized controlled trial, three non-randomized trials and two before-after studies were included. Seven studies used direct moxibustion(two are scarring one) and five used indirect one. Five of twelve studies used moxibustion treatment just one time, except for that most frequency was once daily or 2-3 times per week for 1-2 months. Of ten randomized or non-randomized studies, three used antihypertension drug control and another three used waiting list control. Compare to baseline, change of blood pressure after moxibustion treatment was significant in all studies. However, the results of effect in blood pressure between moxibustion and controlled were not consistent. Methodological quality of clinical trials included in this review was low and has risk of bias, especially in blinding of parcitipant. Conclusions : There are little high-quality clinical trials of moxibustion for hypertension. To evaluate the effect of moxibustion, more rigorous trials are warranted. Also, methodology of clinical trials have to be descripted in detail.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.4
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• pp.566-570
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• 2010

This review was conducted to investigate clinical trial trend, clinical effect, and study methods of forest healing. Literature search was performed using the search engines of eight electronic databases from inception to march 2010 without language limitation. The search terms were "forest healing", "forest experience", "forest therapy", "forest treatment", "clinical trial", and "clinical study". Inclusion criteria were randomized controlled trials (RCTs) among all kinds of study searched about forest healing. Selection literature and data extraction was performed by authors(SH Sun and SG Lee) independently. Total three studies were selected finally. The methodological quality in all study was low because of poor reporting. Study indications were metal health, depression, self-esteem, and stress. The scale of studies was very small, which was the level of pilot study. There were no description for obtaining informed consent and being reviewed by Institutional Review Board (IRB), and could be any problems for statistical method in any studies. It is difficult to accept the fact that each studies had the significant effect for study indications in the results of studies. It is concluded that the evidence that health healing have a significant effect is insufficient. Further systematic and methodological study and well-designed clinical trial will be needed.

• Journal of Society of Preventive Korean Medicine
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• v.19 no.1
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• pp.61-70
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• 2015

Objective : The aim of this study is to investigate the features of clinical trial which used symptom differentiation on cancer patients Method : Electronic databases including Ovid-Medline, Ovid-EMBASE, and Cochrane library were searched. Search terms incorporating the concepts of cancer, herbal medicine, clinical trial were used. Articles described using symptom differentiation in methods were selected. Results : Twelve studies used symptom differentiation for prescribing herbal medicine to cancer patients. A total of 36 symptom differentiation were used. The kind of the herbal medicines was varied as much as the kind of symptom differentiation. Conclusion : Most of herbal medicines used for cancer patients focused on quality of life or adverse events rather than tumor size. Symptom differentiation and herbal medicine used in selected studies were too diverse to categorize. To use standardized symptom differentiation, symptom differentiation instrument should be developed and reliability test and validity test are needed.

• Journal of Internet Computing and Services
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• v.13 no.1
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• pp.45-55
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• 2012

Electronic data management is getting important to reduce overall cost and run-time of clinical data management with the enhancement of data quality. It also critically needs to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop the performance evaluation framework in electronic clinical data management. Four key metrics in the area of infrastructure, intellectual preparation, study implementation and study completion covering major aspects of clinical trial processes are proposed. The performance measures evaluate the extent of regulation compliance, data quality, cost and efficiency of electronic data management process. They also provide measurement indicators for each evaluation items. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management - clinical site, monitoring and data coordinating center. As of the initial attempt how to evaluate the extent of electronic data management in clinical trials by Delphi survey, further empirical studies are planned and recommended.

• The Journal of Internal Korean Medicine
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• v.37 no.1
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• pp.109-134
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• 2016

Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

• Communications for Statistical Applications and Methods
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• v.25 no.5
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• pp.501-512
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• 2018

We propose Sequential Patient Recruitment Monitoring (SPRM), a new monitoring procedure for patient recruitment in a clinical trial. Based on the sequential probability ratio test using improved stopping boundaries by Woodroofe, the method allows for continuous monitoring of the rate of enrollment. It gives an early warning when the recruitment is unlikely to achieve the target enrollment. The packet data approach combined with the Central Limit Theorem makes the method robust to the distribution of the recruitment entry pattern. A straightforward application of the counting process framework can be used to estimate the probability to achieve the target enrollment under the assumption that the current trend continues. The required extension of the recruitment period can also be derived for a given confidence level. SPRM is a new, continuous patient recruitment monitoring tool that provides an opportunity for corrective action in a timely manner. It is suitable for the modern, centralized data management environment and requires minimal effort to maintain. We illustrate this method using real data from two well-known, multicenter, phase III clinical trials.