• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1997년도 추계학술대회
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• pp.57-74
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• 1997

To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

• 한국생물정보학회:학술대회논문집
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• 한국생물정보시스템생물학회 2005년도 BIOINFO 2005
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• pp.85-90
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• 2005

In this paper, firstly we report experimental results on applying information extraction (IE) methodology to the task of summarizing clinical trial design information in focus on ‘Compared Treatment’, ‘Endpoint’ and ‘Patient Population’ from clinical trial MEDLINE abstracts. From these results, we have come to see this problem as one that can be decomposed into a sentence classification subtask and an IE subtask. By classifying sentences from clinical trial abstracts and only performing IE on sentences that are most likely to contain relevant information, we hypothesize that the accuracy of information extracted from the abstracts can be increased. As preparation for testing this theory in the next stage, we conducted an experiment applying state-of-the-art sentence classification techniques to the clinical trial abstracts and evaluated its potential in the original task of the summarization of clinical trial design information.

• 품질경영학회지
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• 제39권2호
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• pp.329-336
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• 2011

The purpose of Phase I clinical trial is to identify the maximum tolerated dose with specific toxicity rate. The standard TER design does not guarantee the pre-specified toxicity rate. It depends on the dose-toxicity curves. Therefore it is necessary to check the expected toxicity rate of various dose-toxicity curves before we conduct clinical trials. We developed TERAplusB library to help this situation, especially in cancer research. This package will help design the cancer clinical trial. We can compare the expected toxicity rates, the expected number of patients, and the expected times calculated with various dose-toxicity curves. This process will help find the best clinical trial design of the proposed drug.

• 의료법학
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• 제15권1호
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• pp.211-237
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• 2014

Because of unpredictability and high possibility of abnormal results by clinical trials compared to general medical behaviors, a procedure for ensuring with sufficient explanations by investigators must be secured. Therefore, in a sequence of clinical trials, what kinds of scope, stage, and method of explanations provided by investigators, including doctors or researchers, to trial subjects are closely related to the compensation for damages by violation of liability for explanation. In case of application of clinical trials to patients who have critical illness such as cancer, issues of "Quality of Life" regarding trial subjects, cancer patients, should be discussed. Especially, in case of clinical trials for terminal cancer patients, the right of subjects' self-determination, which is a fundamental principle in medical behaviors, should be discussed. The right of self-determination includes participation in clinical trials for the possibility of life-sustaining even a little bit, or no participation in clinical trials in order to have a time for completing the rest of his life. Like this, if the extent and scope of explanations related to the issues of "Quality of Life" are raised as main issues, the evaluation of "Quality of Life", should be a prerequisite. In many occasions, realistically, despite bad results such as deaths or serious adverse drug reactions after clinical trials, it may not be easy for compensating to trial subjects or their survivors, who requested civil compensation for damage. Futhermore, in abnormal results after concealment of clinical trials or performance of clinical trials without permission, and in the case of trial subjects' failures of proving proximate cause between the clinical trials and abnormal results, problematic results such as no protection to the trial subjects could be occurred. In performing clinical trials, investigators should provide sufficient explanations for trial subjects and secure voluntary informed consents from the trial subjects. Therefore, clinical trials without trial subjects' permissions and the informed consent process violate trial subjects' rights of self-determination, and the investigators shall be liable for compensation for damages. Then, issues might be addressed are what are essential contents of patients' "rights of self-determination" infringed by clinical trials without subjects' permissions. Two perspectives about patients' rights of self-determination might be considered. One perspective regards physical distress of patients (subjects) from therapies without sufficient explanations as the crux of the matter. The other perspective regards infringement of human dignity caused by being subjects without permission as the crux of the matter irrespective of risks' big and small influences. This research follows perspective of the latter. Forming constant fiduciary relation between investigators (doctors) and subjects (patients) pursuant medical contracts, and in accordance with this fiduciary relation, subjects, who are patients, have expectations of explanations and treatments by the best ways. If doctors and patients set this forth as a premise, doctors should assume civil liability when doctors infringe patients' expectations.

• 의료법학
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• 제17권2호
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• pp.125-144
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• 2016

모든 형태의 임상시험은 시험 자체가 불확실하며, 리스크가 다양하므로 피험자를 보호하기 위한 제도가 완비되어 있어야 한다. 그럼에도 불구하고 현행 임상시험에 관한 법률은 약사법과 의료기기법에서 일정한 규정을 두고 있으나 이는 '의약행정'을 원활하게 수행하기 위한 법목적에 비추어 피험자 보호에는 일정한 한계가 있다. 더 나아가 미성년 피험자를 대상으로 하는 임상시험은 약사법 등에서 직접적인 규정을 두지 않고, '소아를 대상으로 하는 임상시험 평가 가이드라인'이나 '의약품임상시험관리기준' 등에서 일정 부분 규율하고 있으나 이는 법적 효력이 없는 권고사항이라는 점에서 일정한 한계가 있다. 미성년자 대상 임상시험에 대한 법흠결 문제는 인체침습의 정도 면에서 통상적인 의료행위의 경우보다 강한 장기이식법상의 미성년자 취급제도와 기타 외국법상의 미성년자 임상시험 제도를 검토함으로서 입법적 해결이 가능하다고 할 것이다. 그러나 근본적으로는 현행법 체계상 약사법, 의료기기법 기타 가이드라인을 중심으로 이루어지고 있는 임상시험 규율체계를 이른바 "피험자보호법"이라는 법률제정을 통해 해결하는 것이 바람직하다고 본다.

• 대한한의학회지
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• 제38권3호
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• pp.124-142
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• 2017

Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. 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 analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

• 대한한방체열의학회지
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• 제7권1호
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• pp.1-13
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• 2009

Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS, Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

• 대한한방부인과학회지
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• 제21권3호
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• pp.75-89
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• 2008

Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS. Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

• 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.

• Journal of Ginseng Research
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• 제38권4호
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• pp.239-243
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• 2014

Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.