• 한국콘텐츠학회논문지
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• 제11권1호
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• pp.350-356
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• 2011

본 연구의 목적은 전자적 임상시험 데이터 관리를 위한 설계 시 시간적 요인에 주목하여 시스템의 효율성을 검증해 보고자 함이다. 임상시험 데이터 관리에 대한 관심이 커지고 있고 시스템 도입이 활발한 데 반해, 실제 효율성 측정에 관한 실증연구는 많지 않다. 특히 국내의 경우 임상시험 데이터 관리를 위한 전산화 도입률 조차 낮은 실정이다. 본 연구는 전자적 임상시험 데이터 관리에 대한 중요성 인식 확산을 위하여 전자적 시스템의 효과에 대한 실증연구를 시도하였으며, 시간효율성 측정지표를 활용하여 다기관 임상시험 사례의 자료를 분석하였다. 연구결과로서 전자적 시스템으로의 전환이 임상시험 전체 프로세스에 제공할 수 있는 시간 측면에서의 효율성을 검증하였으며 전자적 임상시험 데이터 관리 시스템의 활용 효과를 분석하기 위한 국내 첫 실증연구의 시도라는 의미가 있다. 나아가 전략적 데이터 관리 수립 및 임상단계 별 비교연구 등 향후 다양한 비교 연구들의 초석이 될 것이다.

• 한국콘텐츠학회논문지
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• 제13권4호
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• pp.281-289
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• 2013

최근 국내 임상시험의 양적 증가와 더불어, 임상시험 자료를 효율적으로 관리할 수 있는 Electronic Data Capture(EDC) 시스템의 도입 요구가 증가하고 있다. 이에 따라 식품의약품안전청에서는 '임상시험 전자 자료 처리 및 관리를 위한 가이드라인'을 발표하였다. 이는 향후 국내 임상시험 전자 자료 관리에 관한 법률 제정을 위한 기초가 될 것으로 기대한다. 이 연구에서는 국내 임상시험 관련 기관인 병원과 임상시험 수탁기관(CRO), 그리고 제약회사에서의 EDC 시스템 이용 현황과 관계자들이 인식하는 가이드라인 및 전자 자료 표준의 중요성 및 적용 용이성과 이해도를 조사하였다. 국내 임상시험 관련 기관에서의 EDC 시스템 이용률은 77.6% 이었지만 EDC 시스템을 이용한 임상시험 건수는 5건 미만이 가장 많았다. EDC 시스템은 주로 약물동력학 시험을 하는 phase I과 임상효과와 안전성을 평가하는 phase II 임상시험에서 주로 이용되었고, 기관별로는 CRO의 이용률이 가장 높았다. 모든 집단에서 가이드라인의 중요성은 높게 인식하였으나, 적용 용이성 측면에서는 CRO에서 가장 높았다. 또한, 임상시험 전자 자료 표준의 중요성을 높게 인식하였고, 전자 자료 수집에 있어 표준의 필요성을 높게 인식하였다. 그러나 임상시험 전자 자료 국제표준인 Clinical Data Interchange Standard Consortium(CDISC)에 대한 이해도는 아직 낮은 수준이었다. 이 연구 결과는 국내 임상시험 전자화를 위한 기초자료로 활용될 수 있으며 임상시험 자료 표준에 관한 정책수립에도 활용될 수 있을 것이다.

• Korean Journal of Acupuncture
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• 제28권3호
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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.

• 한방안이비인후피부과학회지
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• 제30권3호
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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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• 제28권5호
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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.

• 동의생리병리학회지
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• 제24권4호
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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.

• 대한예방한의학회지
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• 제19권1호
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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.

• 인터넷정보학회논문지
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• 제13권1호
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• pp.45-55
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• 2012

임상시험 전체 소요시간 및 비용의 절감, 임상 데이터 질의 향상을 위해 임상시험 전자자료의 관리가 점차 중요해지고 있다. 또한 임상시험 전자자료 관리는 전자 임상시험의 안정성 및 질을 위해 규정 가이드라인을 준수하는 것이 결정적으로 필요하다. 본 연구는 전자적 시스템을 활용한 임상시험에 있어 데이터 관리의 성과를 평가하기 위한 프레임웍을 개발하고자 한다. 연구의 목적을 위해 임상시험 프로세스에 근거하여 기반능력, 연구설계, 연구진행 및 연구완료 등 네 개의 주요 메트릭을 구성함으로써 데이터 관리의 수준을 측정할 수 있는 성과척도를 도출한다. 이때 각 성과척도의 도출 기준은 임상시험 자체가 지향하는 데이터의 질 향상, 전자자료 관리 프로세스의 비용과 효율성 및 규정 준수 수준 등 네 가지의 관리적 관심을 기준으로 하며, 각 성과척도 별로 전자자료 관리 프로세스 상 실질적으로 측정 가능한 측정지표를 제시한다. 평가 프레임웍은 네 가지의 주요 측정 메트릭에 근거하여, 세 개의 데이터 영역(연구기관, 모니터링, 데이터관리센터) 별로 구성된다. 본 평가 프레임웍의 개발은 전문가 의견 수렴을 통한 델파이 방법론으로 접근한 탐색적 연구로서 향후 실증적 후속 연구를 과제로 남기고 있다.

• 대한한방내과학회지
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• 제37권1호
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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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• 제25권5호
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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.