• 의료법학
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• 제13권2호
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• pp.79-113
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• 2012

This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

• Journal of Ship and Ocean Technology
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• 제3권3호
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• pp.25-44
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• 1999

Estimation efficiencies according to different sea trial are investigated in connection with sensitivity analysis, and new trial method is proposed which can improve the estimation efficiency of hydrodynamic derivatives. MMG Equation with Kijima's formula is used for simulation. Extended Kalman Filter is chosen for estimation technique and hydrodynamic derivatives of interest is limited to 12 of those in sway and yaw equations. Esso Osaka is selected for the test ship. Sensitivity analysis and estimation results based on conventional trials show that a more sensitive derivative gives more efficient estimation result. Sensitivities of nonlinear derivatives become pronounced in the trial where steady condition lasts longer such as turning test, while sensitivities of linear derivatives gas a larger values in the trial where unsteady condition lasts longer such as 10deg-10deg zigzag test. Consequently, in new method , named S-type trial, steady and unsteady condition are combined appropriately to increase sensitivities. Linear derivatives are estimated better in S-type trial and the estimation of nonlinear derivatives is improved to extent.

• 한국콘텐츠학회논문지
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• 제11권12호
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• pp.250-257
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• 2011

사법의 민주적 정당성을 강화하고 투명성을 높임으로써 국민의 신뢰확보를 위하여 마련된 국민참여재판이 시행된지 벌써 3년 10개월이 지났다. 형사사법절차에 국민이 참여하는 절차적 민주주의와 공정하고 신중한 재판이 실현되고 있다는 점에서 긍정적 평가를 받을 수 있다. 그러나 국민참여재판은 극소수의 사건을 재판대상으로 하여 배심원의 평결에 권고적 효력만 인정하고 구속력을 인정하지 않는 한계가 있다. 뿐만 아니라 대상사건의 한정, 피고인의 선택제, 배제결정제도, 법관의 평의관여 및 배심원의 다수결평결 등의 문제점을 여전히 갖고 있다. 따라서 본고는 국민참여재판에 대한 몇 가지 쟁점과 문제점을 검토한 후 이에 대한 대안을 제시하는 것을 연구의 초점으로 한다.

• 한국한의학연구원논문집
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• 제12권1호
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• pp.13-22
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• 2006

Background and Aims: Herbal drugs and traditional medicines have lately attracted considerable attention by global pharmaceutical corporations because the conventional chemical drugs didn't work well for many chronic diseases or intractable diseases. The government of Korea is also supporting to develop the new drug which is high value added product, and the natural medicine including herbal medicine(or Traditional Korean Medicine) have a significant presence in this field. non-clinical pharmacology/toxicology study and clinical trial are the two major criteria which estimate efficacy and safety for registration of new drugs. All of the pharmaceutical companies producing herbal medicine and the academic and the academic world of Tradition Korean Medicine have the will to develop new herbal drugs, but there are obstacles that they have neither experience nor guideline about clinical trial. Therefore for developing new herbal drugs, it is necessary to research the present conditions and comprehensive systems about clinical trial in Northeast Asian countries China, Taiwan and Japan because they have the common background with Korea in traditional medicine fields. Methods : The present state of clinical trial for herbal medicine in Korea was investigated. And then, those in China, Taiwan, Japan was also investigated. Results and conclusions : There are significant differences among 4 Southeast Asian countries Korea, China, Taiwan and Japan each in present condition, purpose, involved comprehensive system including legislation, and actual operation of clinical trial for traditional medicine.

• 종양간호연구
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• 제6권2호
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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.

• 한국마린엔지니어링학회:학술대회논문집
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• 한국마린엔지니어링학회 2005년도 후기학술대회논문집
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• pp.73-74
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• 2005

Shipping company and operators have to manage well to keep shipping schedules without problems in main engine. Specially operators have to operate main engine within the limit of operation point, and adjust related parameters to be operated safely and continuously. Also operators have ability to analyze fouling condition of hull through comparing data gotten from P-V curve and performance results of new building ships in trial with service ships. In this study, not only compared main engine performance results in shop trial and sea trial, but also investigated performance trend in accordance with the time elapsed for the service ship's diesel engine. They were confirmed as follows. First, shop trial load is higher than sea trial load but ship's speed is satisfied with owner's contract speed. Second as time goes by, load of service ship increases steadily and other parameters related with main engine shows variable change depend on main engine load increasing.

• 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.

• 응용통계연구
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• 제25권4호
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• pp.575-587
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• 2012

The effect of a new treatment is proven through the comparison of a new treatment with placebo; however, the number of parent non-inferiority trials tends to grow proportionally to the number of active controls. In a non-inferiority trial a new treatment is approved by proof that the new treatment is not inferior to an active control; however, both additional assumptions and historical trials are needed to show (through the comparison of the new treatment with the active control in a non-inferiority trial) that the new treatment is more efficacious than a putative placebo. The two different methods of using the historical data: frequentist principle method and meta-analytic method. This paper discusses the statistical methods and different Type I error rates obtained through the different methods employed.

• Tuberculosis and Respiratory Diseases
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• 제71권3호
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• pp.163-171
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• 2011

Recently published articles on interstitial lung disease (ILD) have focused on the accurate diagnosis of idiopathic pulmonary fibrosis (IPF), serum biomarkers, acute exacerbation of IPF, the prognostic factors of ILD and the trial of new treatment. In particular, reports on the serum biomarkers such as CC-chemokine ligand 18, surfactant protein, circulating fibrocytes, and acute exacerbation of IPF are sufficient to be mentioned here. Pirfenidone therapy is the most important trial for the treatment of IPF. Other newer treatment trials such as interferon-gamma, sildenafil and imatinib have been reported to be unsuccessful. On the other hand, the sirolimus trial for lymphangioleiomyomatosis is promising. Combined pulmonary fibrosis and emphysema and IgG4-related disease are established to be the new disease entities of ILD.

• 한국철도학회:학술대회논문집
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• 한국철도학회 2008년도 춘계학술대회 논문집
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• pp.339-342
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• 2008

In this paper, the lessons and learns are introduced from the result of the trial project which is the first CBTC(Communication Based Train Control System) at Korail Bundang Line. This project has started end of 2002 and finished recently by Samsung SDS. The main purpose of this project was that new technology was seek for next generation of railway signal control system adapted in Korea. In 2002, there was no any revenue service system using Radio Frequency CBTC in the world at that time. Just a few trial project was on going in USA and EU. In well developed cities, the metro system have been built and old enough therefore they have to be considering re-signalling their existing system with advanced system for increasing availabilities of line usage and safety. This Bundang Line Trial Project was the first Korean CBTC project for above reasons. Most sub systems have been developed using local technology such as Electronics Controlled Interlocking System and Track Circuit Systems etc. Specially, in this project the RF-Communication devices are developed by local technology using DSSS(Direct Sequency Spread Spectrum) instead of FHSS(Frequency Hopping Spread Spectrum). This project has lasted for more than five years originally planned for three years because it was only accessible only night time in the main line from Ori to Suseo about 20km long. Each night only 2 and half hours are available to use the main line. Now the trial project has been done successfully with meet the customer's requirement, therefore the upgrade the mainline of Bundang line and another extension area up to Wangsipli to make revenue service using this new technology. This paper shows this result of the trial project and the strategy of upgrade and extension project as well.