• 대한임상약리학회:학술대회논문집
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• 2006.11a
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• pp.141-142
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• 2006

• Journal of Acupuncture Research
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• v.26 no.5
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• pp.105-116
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• 2009

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.257-285
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• 2011

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.172-176
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• 2018

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.

• 한국약용작물학회:학술대회논문집
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• 2011.09a
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• pp.240-241
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• 2011

• The Journal of Internal Korean Medicine
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• v.28 no.2
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• pp.363-376
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• 2007

Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

• Asian Oncology Nursing
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• v.6 no.2
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• pp.121-132
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• 2006

Purpose: The purpose of this study was to describe the lived experience of the patients with cancer participating in a clinical trial for the development of a new drug. Method: This study was based on a phenomenological approach. The eight patients participating in a clinical trial were selected as the participations of this study. The data were obtained through in-depth interviews from the participants and were analyzed using the Giorgi method. Results: Essential experiences of the patients with cancer under a clinical trial consisted of anticipating recovery of physical health and a social role, passing the strict criteria of a clinical trial, diminishing economic burden, satisfaction with special treatment receiving, social contribution, concerns about side effects and withdrawal from the clinical trial, conflicts as a participant, pain, limited administration of other treatments, regret for giving up other treatments, strict compliance with instructions, prevention of side effects and maintaining desirable life-style. Integrated units of meaning of these components were hope, good luck, a sense of satisfaction, fear, distress, and the will of self-control. Conclusion: The most essential meaning of the cancer patients participating in a clinical trial was hope. Hope was found to be a primary factor reinforcing the will of self-management. The results of this study can be of great help to the research nurses to understand the lived experience of the patients with cancer and to plan an effective nursing intervention for the patients.

• Proceedings of the Korean Society for Bioinformatics Conference
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• 2005.09a
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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.

• Journal of Korean Society for Quality Management
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• v.39 no.2
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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.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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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.