• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of International Convention of the Pharmaceutical Society of Korea
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• pp.317.1-317.1
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• 2001

• 대한한방부인과학회지
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• 제24권2호
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• pp.97-103
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• 2011

Objectives: Recently, high attention has been drawn towards evidence based medicine(EBM). However, there is little follow study after Park's analysis research (2002) in the journal of oriental gynecology. Therefore, there is a need to conduct analyzed research on the topic, due to the increasing interest about EBM. Methods: To analyze the treatises of the journal of oriental gynecology, we examined 56 journals published from 1987 to 2010. we followed the way of Park, classifying treatises into bibliographic, experimental and clinical categories. Results: Analytic research, as a part of clinical treatises, increased rapidly from 2001. As a result, it took 53.3% of whole study in general after 2002 and it reached up to 70.0% in 2004. Most part of clinical treatises until 2002 was about case report of patients, but the amount of clinical trial started to increase since 2003. Case report and case series showed dramatic increase after 2001, and clinical trial started to increase after 2003. As a result, 43.8% of the analyzed research was due to clinical trial by 2009. Conclusions: On the base of this research, quality evaluation of clinical treatises using guality assessment tool is needed for EBM in the part of oriental obstetrics & gynecology.

• 한국정보과학회논문지:컴퓨팅의 실제 및 레터
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• 제15권8호
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• pp.566-575
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• 2009

CDISC 컨소시엄에서는 임상시험에서의 비효율적인 데이터 처리 과정을 개선하기 위해, 플랫폼에 독립적인 임상시험 데이터 표준을 정의하였다. 그러나, CDISC 표준은 여러 나라의 여러 기관이 함께 참여하는 다국가 임상시험에서 발생하는 임상시험 데이터를 다국어로 표현하는 방법에 많은 제약을 갖고 있다. 특히, CDISC가 제정한 표준 중 임상시험 데이터의 콘텐츠 및 포맷에 해당하는 SDTM(Study Data Tabulation Model)과 ODM(Operational Data Model)에서의 다국어 지원이 매우 미비하다. 본 논문은 CDISC의 SDTM과 ODM에서의 언어 설정에 대한 문제점을 해결하기 위해, SDTM과 ODM 표준의 확장을 제안한다. 이를 위해 SDTM에서는 다국어 지원을 위한 새로운 도메인을 설계하였고, ODM에서는 ODM의 확장 스키마를 서브타이핑 방법으로 구현하였다. 확장 SDTM과 ODM을 기반으로 임상시험 데이터를 처리하면, 다국가 임상시험이 수행되는 경우 다국어로 표현된 임상시험 데이터도 효율적으로 처리할 수 있다.

• 한국임상약학회지
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• 제33권3호
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• pp.178-185
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• 2023

Objective: Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disease. Both tralokinumab and dupilumab have been recommended in the European Guideline for the treatment of adult patients with severe AD. In Korea, dupilumab has been approved for patients with moderate to severe AD, and reimbursed for those with severe AD. Since there is no clinical trial directly comparing tralokinumab and dupilumab, we conducted indirect comparison to assess the clinical usefulness in patients with AD. Methods: We selected clinical trials for indirect comparison through a systematic literature review. Individual patient data were available for the tralokinumab clinical trial, and aggregated data were available for the dupilumab clinical trial. Therefore, we employed the Matching-Adjusted Indirect Comparison (MAIC) method. The treatment efficacy was assessed based on whether patients achieved a 75% reduction on the Eczema Area and Severity Index (EASI 75) after drug administration. Results: The difference in the proportion of patients achieving EASI 75 between tralokinumab and dupilumab was 4.7% (95% CI: -7.9 to 17.3). Considering the non-inferiority margin for the EASI 75 achievement rate is -10%, tralokinumab is deemed non-inferior to dupilumab as the lower bound of the CI for the difference in the EASI 75 achievement rate between tralokinumab and dupilumab was within -10%. Conclusion: We conducted a MAIC analysis comparing tralokinumab and dupilumab based on EASI 75 achievement. The findings of this study show that tralokinumab is non-inferior to dupilumab and can be implemented in Korean clinical settings with a therapeutic position comparable to dupilumab.

• 대한한방소아과학회지
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• 제37권3호
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

• 대한한의학회지
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• 제40권1호
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

• 한국의료질향상학회지
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• 제27권1호
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• pp.20-25
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• 2021

Purpose: The ability to access clinical trials for cancer treatment is important. This study investigated whether regional differences exist in oncologic clinical trial protocols conducted in South Korea. Methods: Records of all approved oncologic clinical trials conducted in 2019 were downloaded from the Republic of Korea Ministry of Food and Drug Safety. The study covered Seoul, the capital area, other metropolitan cities, and provincial areas. Descriptive statistics summarized the distribution patterns of clinical trials by region. Results: A total of 202 oncologic clinical trials were conducted in 63 institutions in 2019. Of these protocols, 186 (92%) were available in Seoul, 120 (59%) in the capital area, 64 (32%) in metropolitan cities, and 66 (33%) in provincial areas. More regional differences in protocol availability were observed in domestic trials, investigator-initiated trials, phase 1 and 2 trials, and smaller-scale trials. Conclusion: Most oncologic clinical trials were conducted in medical institutions located in Seoul, with the rest conducted in the capital area, metropolitan cities, and provincial areas. The findings reveal clear differences in protocol availability between Seoul and the other regions. Measures designed to improve geographical access to oncologic clinical trials may be needed given their growing importance in cancer treatment.

• Journal of Acupuncture Research
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• 제23권1호
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• pp.165-177
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• 2006

Objectives : 1. Clinical trial for the efficacy evaluation of Korean acupuncture techniques in treating frozen shoulder. 2. Development of the standard clinical guidelines of the acupuncture treatment for the frozen shoulder. 3. Development of the new clinical protocol for the acupuncture treatments. 4. Verification of the hypothesis that treating at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints. Methods : 1. Research designed as Single blind, Randomized, Sham acupuncture controlled clinical Trial. 2. Assignment of 86 patients to one of three groups treated at nearby acupoints(group A), remote & nearby acupoints(group B), and sham points(group C) respectively. 3. Trial conducted at KIOM CRC of Dunsan oriental medical hospital, Daejeon Univ. 4. Estimation of the recovery rate of the frozen shoulder in subjects aged over 40. 5. Efficacy evaluation using VAS, SPADI, ROM and Improvement rate. Results : 1. There was no significant difference in VAS among the three groups. 2. Pain related scores in SPADI of the group B were significantly lower than those of the group A. 3. There was no significant difference in disability related scores of SPADI among the three groups. 4. External rotation of upper arm in the group B was significantly improved in comparison with that in the group C. 5. Abduction of upper arm in group A was improved with weak statistical significance in comparison with that in the group C. Conclusion : Acupuncture at both the remote and the nearby acupoints according to the meridian theory is effective to improve external rotation of frozen shoulder, and acupuncture at the nearby acupoints is effective to improve adduction of frozen shoulder. However it is not clear that acupuncture treatment at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints in the treatment of frozen shoulder. Since our study was a short term trial, a long term trial for a more precise evaluation of acupuncture treatment for frozen shoulder will be needed in the future.

• 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.

• 대한통합의학회지
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• 제10권3호
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• pp.27-36
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• 2022

Purpose : This study was aimed to analyze the effects of cosmetics containing Persicaria perfoliata water extract (PPWE) on the skin moisturizing and improvement of skin condition in clinical trials. Methods : Clinical trial was conducted for five weeks after IRB approval at Dong-Eui University. Out of a total of 64 people, 15 people each were assigned to four groups as follows; control group A, B, C and the experimental group A that using cosmetic containing PPWE. Skin condition was measured two times, before and after clinical trial, by a professional skin analyzer, SDM (skin diagnosis system). Moisture and oil value of participants was analyzed twice, each morning and evening, using a portable device on their cheeks. In addition, the survey was investigated subjective satisfaction on change in skin condition and the satisfaction on the use of cosmetics. Result : The experimental group exhibited subjectively significant changes before and after clinical trials on skin its dryness (p=.039), blush (p=.017), and redness (p<.001). In addition, subjective evaluation was also the highest satisfaction in aspects of number of application (p=.003), amount of application (p=.002), moisture maintenance, and skin scratching frequency. The satisfaction on the use of cosmetics was the highest in the intention to repurchase (p=.045), recommendation willingness to others (p=.020), and intention to use various products (p=.001). Skin moisture of the clinical trial participants using the SDM, moisture level and elasticity of the experimental group increased by 12.94 and 10.28. Moisture level, which was measured by a portable device, was the most potently increased in the experimental group. Conclusion : Consequently, PPWE containg cosmetics exhibited the effects of moisturization and attenuated skin dryness in clinical trials, which might be utilized as a fundamental data to develop numerous lines of cosmetics.