• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 1999년도 제8차 추계학술대회 및 정기총회
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• pp.44-44
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• 1999

• 한국임상약학회지
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• 제5권2호
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

• 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.

• Journal of the Korean Data and Information Science Society
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• 제23권6호
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• pp.1085-1091
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• 2012

제 1상 임상시험의 주목적은 신약 후보 물질의 독성을 평가하여 부작용 및 안전하게 투여할 수 있는 약물의 적정한 용량인 최대허용용량의 추정이다. 기존에 최대허용용량을 추정하는 방법에는 표준방법 (Storer, 1989; Korn 등, 1994) 그리고 NM방법 (Lee와 Kim, 2012) 등이 있다. 본 연구에서는 많은 피험자들이 낮은 용량에 많이 할당되는 점을 보완하고 기존의 최대허용용량 추정법보다 적은 수의 피험자로 실험하기 위해서 기존 최대허용용량 추정법을 수정한 멈춤 규칙을 적용시킨 추정법을 제안하였다. 기존의 방법들과 새롭게 제시한 방법을 모의실험을 통하여 비교하였다.

• 응용통계연구
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• 제32권5호
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• pp.741-752
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• 2019

제1상 임상시험의 주목적은 최대허용용량(maximum tolerated dose; MTD)을 결정하는 것이다. MTD 결정을 통해 다음 임상시험에 사용될 용량이 제한되므로 투약용량 발견 시험이라고도 불리며 매우 중요한 단계이다. MTD를 결정하는 방법에는 대표적으로 DM 방법, SM 방법, CRM 방법이 있다. 본 논문에서는 기존 수정된 CRM 방법에 초기가속화 단계를 적용하여 낮은 용량에 다수의 피험자가 할당되는 문제점을 보완하는 새로운 MTD 추정 방법을 제안하였고 기존 방법들과의 비교를 위해 모의실험을 실시하였다.

• 한방안이비인후피부과학회지
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• 제28권3호
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• pp.48-65
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• 2015

Objectives : The aim of this study is to analyze recent clinical research of the acupuncture for the treatment of tinnitus.Methods : We searched pubmed for foreign journals with the title/abstract 'tinnitus, acupuncture' published in the last 10 years, and for domestic journals we searched NDSL, RISS, KISS, The National Assembly Library, The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology with the same conditions as foreign journals.Results : We selected total 10 papers: 7 RCTs, 1 RCT protocol, 1 clinical trial, 1 Systematic Review. In RCT, all studies showed positive effect, however in comparison with the control groups, only 2 studies showed meaningful effects.Conclusions : Positive effect of the acupuncture on tinnitus is expected, but because of several limits observed in many papers, we can't draw defined conclusions. Further well-designed researches are needed.

• Asian Pacific Journal of Cancer Prevention
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• 제13권12호
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• pp.6337-6342
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• 2012

Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

• 대한한방내과학회지
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• 제37권1호
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• pp.90-108
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• 2016

Objectives: This study aimed to learn what should be considered in the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD) by analyzing the existing guidelines and clinical trials.Methods: The development committee searched the existing guidelines for herbal medicinal products or GERD. Then, clinical trials related to GERD using herbal medicine were selected. The chosen trials were analyzed in terms of their inclusion and exclusion of participants, intervention, comparators, outcome, and trial design. Then, we compared the results of the analysis according to the regulations and guidelines of the Ministry of Food and Drug Safety to suggest the issues that we will have to consider when developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).Results: As a result, few guidelines for GERD and clinical trials with herbal medicinal products were located in the national institution homepage. In addition, 8 articles were found using the following combination of search terms: “Gastroesophageal reflux disease”, “GERD”, “herbal medicine”, “herbal therapy”, “Korean Medicine”, “Traditional Chinese Medicine”, and “TCM”. Even though all trials had their own unique research questions, all studies were performed using a randomization method. Most trials included participants with reflux esophagitis, but two trials targeted proton pump inhibitor-refractory GERD. The type of intervention varied, such as decoction, granules, and capsules. Additionally, individualized herbal medicines were used in two studies. Comparators were diverse, such as placebo, Western medicine, and electro-acupuncture. The most frequently used outcome for efficacy was the effectiveness rate. In addition, the outcome for evaluating quality of life, esophageal mucosa and pressure, esophageal acid reflux, and recurrence rates were used. Safety was investigated by recording adverse events and carrying out laboratory tests.Conclusions: We identified some issues by reviewing the existing guidelines and comparing them with clinical trials for GERD and herbal medicinal products. These results will be utilized for developing the Guidelines of Clinical Trials with Herbal Medicinal Products for Gastroesophageal Reflux Disease (GERD).

• Communications for Statistical Applications and Methods
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• 제5권3호
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• pp.707-722
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• 1998

This paper evaluates a new clinical trial designs for low infection rate disease. This type of sparse disease reaction makes the traditional two sample t-test or Wilcoxon rank-sum test inefficient compared to a new test suggested. The new test, which is based solely on the larger changes, is shown to be more effective than existing method by simulation for small samples. However, this test can be shown to be connected to the locally most powerful rank test under certain practical conditions. This design is motivated in testing the treatment effects in periodontal disease research.

• 대한약학회:학술대회논문집
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• 대한약학회 2001년도 Proceedings of International Convention of the Pharmaceutical Society of Korea
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• pp.317.2-318
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• 2001