• 동의생리병리학회지
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• 제27권1호
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• pp.26-33
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• 2013

The present study explored studies directed at elucidating the effectiveness of Korean medicine in the treatment of sterility and systematically analyzed the trends of studies on sterility. The standardization and objectification based on results for this study may contribute to the development of effective Korean medicine in reducing sterility. In the annual tendency of sterility-related clinical studies, the number of papers began to increase rapidly from 2000, and 15 papers were published from 2000 till 2011. Then, in the technical journals publishing them, The Journal of Oriental Obstetrics & Gynecology published 13 the most papers. In the institutions to which the first authors belonged, Dongguk University Hospital had 5 the most papers. In the number of test subjects was also analyzed and as the result the studies with 1~9 were the most as 10. In the study design analysis, there were 10 case reports, 5 case series and 4 before and after studies. In the analysis of intervention methods, there were 10 papers where only the Korean medicines were given, next 6 papers where the acupuncture and moxibustion were added, and 3 papers where the Korean medical therapies and other subsidiary therapies were used. In the analysis on the existence of pattern identification, there were 12 papers with the pattern identification, 6 without the pattern identification and 1 with the four constitution identification. In the IRB approval, 18 or most papers had not received the IRB approval and just 1 paper got the IRB approval. When the sterility-related clinical studies published in the Korean medical journals were surveyed, it turned out that there are no RCT studies and there is just one study with the IRB approval. And there were 6 papers without the pattern identification of Korean medicine. So, it seems necessary in the future to improve the papers in these respects for the development of Korean medicine sterility treatment with a good basis through the more systematic and accurate study method.

• 의료법학
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• 제22권4호
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• pp.59-88
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• 2021

최근 제약기업이 조작한 자료를 제출하여 심사를 받아 의약품 품목허가를 받은 사례들이 적발되었다. 국회는 제약기업의 자료조작에 대한 제재를 강화하는 입법을 하였다. 현재와 같은 의약품 품목허가 제도는 Elixir Sulfanilamide 사고나 탈리도마이드 사고와 같이 의약품으로 인하여 환자들의 생명과 건강에 중대한 피해를 초래한 사건들을 경험하면서 그것을 방지하기 위하여 만들어졌다. 의약품 품목허가에는 위험이 내재되어 있다. 의약품 품목허가는 제약기업이 제출한 자료에 조작이 없다는 신뢰를 토대로 한 심사를 통해 우리 사회에 진입 가능한 위험에 대한 잠정적 허용 결정이다. 제약기업의 자료조작은 국민의 생명, 건강에 위해를 가하고 우리나라 제약산업의 경쟁력에 위해를 초래한다. 제약기업의 경제적 이윤 동기를 고려하면 우리나라 제약산업에서 자료조작이 '합리적인' 선택으로 자리잡을 우려가 있고 그럴 경우 그로 인한 피해가 일상화된다. 대법원 2008. 11. 13. 선고 2008두8628 판결은 제약기업이 아닌 제3자가 자료조작을 하였고 자료조작을 하지 않았어도 품목허가 요건이 충족되는 사례에서 의약품 안전성 확보를 위해 엄격하고 엄정한 기준이 요구된다고 밝히며 의약품 품목허가 취소 처분이 위법하지 않다고 판단하였다. 대법원의 입장이 타당하다. 제약기업이 자료조작으로 얻을 수 있는 기대이익을 최소화함으로써 제약기업이 자료조작을 선택할 경제적 유인을 약화시켜야 한다. 그러므로 해당 의약품의 품목허가를 취소할 뿐만 아니라 제약기업이 그로 인하여 얻은 '부당한' 이익을 환수해야 한다. 그리고 자료조작 적발 가능성을 높이기 위하여 내부자 고발을 활성화하고 품목허가 심사료 현실화 등을 통하여 품목허가 심사 인력 등 심사역량을 강화해야 한다.

• Translational and Clinical Pharmacology
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• 제26권4호
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• 의료법학
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• 제22권4호
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• pp.159-184
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• 2021

첨단재생바이오법의 제정 의의는 본질적으로 '이식'이라는 의료행위인 재생의료를 약사법 규제에서 벗어나 의료기술적 접근으로 환자치료기회를 확대하는 데 있다. 그러나, 법이 시행된 지 1년여가 지난 상황에서 식약처가 승인하는 고위험연구는 1건도 승인되지 않고 있는 등 임상연구가 활성화되지 않고 있다. 그 이유는 환자치료기회 확대를 위한 법률 취지에도 불구하고 법률적 근거가 미흡함에도 임상연구 승인을 위한 자료요건을 의약품 개발과 연결하여 정하고 있어 많은 연구자들이 자료요건을 맞추기가 어려운 실정이다. 법 제정 이전 약사법 체계 내의 세포치료제 임상연구를 위한 제출자료는 품질 및 비임상시험 자료가 상당히 면제되었지만, 첨단재생바이오법이 시행되면서 임상연구 계획 승인신청 시 품질 및 비임상시험자료를 의약품에 준해 요구하고 있다. 이를 바로잡으려면 치료기회 확대를 위한 첨단재생의료 임상연구의 정체성을 고려할 때 의약품 개발과 연결하는 데는 제한점이 있음을 인식하고 첨단재생의료 임상연구의 정체성을 지키고, 한편으로 품목허가 시 임상연구 결과를 활용할 수 있도록 하면서 활용요건을 구체화하여 시장의 힘으로, 임상연구자의 자발적인 동기로 임상연구 승인을 위한 기본요건보다 필요한 자료를 스스로 준비할 수 있도록 해야 한다.

• 응용통계연구
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• 제30권3호
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• pp.391-401
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• 2017

본 연구는 노인장기요양보험 수급자격을 결정하는 장기요양 등급인정의 지역별 차이를 관리하기 위해 지역별 인정의 차이 관리지표를 개발하고자 수행되었다. 이를 위해 지역별 인정률은 시군구 지역단위별로 설치된 227개 장기요양운영센터의 등급판정자 대비 인정자 비율인 운영센터별 인정률로 정의하고, 등급판정을 받은 자(등급판정자)의 특성에 따라 장기요양 등급인정 여부가 결정되므로, 운영센터별 인정률은 등급판정자의 특성에 의해 영향을 받는다고 가정하였다. 또한 운영센터 인정률에 영향을 미치는 등급판정자 특성 요인을 고려하여 추정된 운영센터별 인정률은 표준인정률이라 정의하였고, 관찰된 인정률 간의 차이(오차)가 클수록 등급판정자의 특성 외의 요인이 인정률에 영향을 끼쳤다고 가정하여 이 지역의 등급인정에 오류가 있다고 판단하였다. 관리지표 개발을 위해 2015년 1월 1일부터 12월 31일까지 장기요양 등급판정이 완료된 433,115명의 인정조사 자료와 등급판정을 실시한 인정조사자 특성을 활용하였다. 운영센터별 관리지표 생산을 위해 분석대상자가 장기요양 등급을 부여 받은 운영센터를 기준으로 자료를 변환하여 회귀분석을 실시하였다. 연구결과, 등급판정자의 인구사회학적 특성과 장기요양 등급 재신청 비율에 영향을 받는 것으로 나타났다. 이를 통해 운영센터 인정의 차이 관리지표를 산출하였고, 인정의 차이 값이 전체 분포의 중앙95% 구간을 벗어난 운영센터를 등급인정에 오류가 있는 지역으로 확인하였다. 본 연구에서 제안한 지역별 인정의 차이 관리지표를 통해 장기요양 등급판정에 대한 국민적 신뢰도 제고와 형평성 향상에 기여할 것으로 기대한다.

• Journal of Preventive Medicine and Public Health
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• 제40권4호
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• pp.278-284
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• 2007

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

• 한국의사학회지
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• 제27권2호
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• Korean Journal of Radiology
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• 제25권5호
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• pp.414-425
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• 2024

Objective: This study aims to explore the opinions on the insurance coverage of artificial intelligence (AI), as categorized based on the distinct value elements offered by AI, with a specific focus on patient-centered outcomes (PCOs). PCOs are distinguished from traditional clinical outcomes and focus on patient-reported experiences and values such as quality of life, functionality, well-being, physical or emotional status, and convenience. Materials and Methods: We classified the value elements provided by AI into four dimensions: clinical outcomes, economic aspects, organizational aspects, and non-clinical PCOs. The survey comprised three sections: 1) experiences with PCOs in evaluating AI, 2) opinions on the coverage of AI by the National Health Insurance of the Republic of Korea when AI demonstrated benefits across the four value elements, and 3) respondent characteristics. The opinions regarding AI insurance coverage were assessed dichotomously and semi-quantitatively: non-approval (0) vs. approval (on a 1-10 weight scale, with 10 indicating the strongest approval). The survey was conducted from July 4 to 26, 2023, using a web-based method. Responses to PCOs and other value elements were compared. Results: Among 200 respondents, 44 (22%) were patients/patient representatives, 64 (32%) were industry/developers, 60 (30%) were medical practitioners/doctors, and 32 (16%) were government health personnel. The level of experience with PCOs regarding AI was low, with only 7% (14/200) having direct experience and 10% (20/200) having any experience (either direct or indirect). The approval rate for insurance coverage for PCOs was 74% (148/200), significantly lower than the corresponding rates for other value elements (82.5%-93.5%; P ≤ 0.034). The approval strength was significantly lower for PCOs, with a mean weight ± standard deviation of 5.1 ± 3.5, compared to other value elements (P ≤ 0.036). Conclusion: There is currently limited demand for insurance coverage for AI that demonstrates benefits in terms of non-clinical PCOs.

• 대한이식학회지
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• 제31권4호
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• pp.157-169
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• 2017

Regulatory T cells (Treg) naturally rein in immune attacks, and they can inhibit rejection of transplanted organs and even reverse the progression of autoimmune diseases in mice. The initial safety trials of Treg against graft-versus-host disease (GVHD) provided evidence that the adoptive transfer of Treg is safe and capable of limiting disease progression. Supported by such evidence, numerous clinical trials have been actively investigating the efficacy of Treg targeting autoimmune diseases, type I diabetes, and organ transplant rejection, including kidney and liver. The limited quantity of Treg cells harvested from peripheral blood and subsequent in vitro culture have posed a great challenge to large-scale clinical application of Treg; nevertheless, the concept of CAR (chimeric antigen receptor)-Treg has emerged as a potential resolution to the problem. Recently, two CAR-T therapies, tisagenlecleucel and axicabtagene ciloleucel, were approved by the US FDA for the treatment of refractory or recurrent acute lymhoblastic leukemia. This approval could serve as a guideline for the production protocols for other genetically engineered T cells for clinical use as well. The phase I and II clinical trials of these agents has demonstrated that genetically engineered and antigen-targeting T cells are safe and efficacious in humans. In conclusion, both the promising results of Treg cell therapy from the clinical studies and the recent FDA approval of CAR-T therapies are paving the way for CAR-Treg therapy in clinical use.

• 대한약침학회지
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• 제25권1호
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• pp.46-51
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• 2022

Objectives: This study was performed to evaluate the skin irritation toxicity of processed sulfur. Methods: All experiments were conducted at Medvill (Korea), an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate skin irritation toxicity of processed sulfur, we divided the back of six rabbits into two control sites and two test sites. One of each of the two control and test sites was then designated abraded sites and intact sites. In test sites, 0.5 g of processed sulfur was applied to the back of the rabbit for 24 hours, and in control sites, 0.5 g of sterile distilled water was applied in the same way. We observed and evaluated mortality, weight, general symptoms, and skin irritation toxicity. This study was conducted with the approval of the Animal Ethics Committee (Approval number: IAC2020-1549). Results: In all experiments, no dead animals were observed. In all cases, skin coloration was observed at 24 hours after processed sulfur administration. This coloration lasted up to 48 hours and is believed to be the effect of the administration of test substances. Weight measurement indicated that weight was lost 72 hours after administration in three cases, but this is considered an accidental weight change. Normal weight gain was observed in the remaining subjects. In all animals, no skin irritation toxicity was observed, and the primary irritation index (P.I.I) was calculated as 0.0 according to Draize's evaluation method. Conclusion: The above findings suggest that it is relatively safe to apply a processed sulfur to the skin. Further research on this topic is needed to provide more specific evidence.