임상시험용 의약품 복약지도 항목에 대한 임상시험대상자 및 연구자의 요구도 조사

유소현,김유경,이정선,한옥연,나현오 한국병원약사회 2017 병원약사회지 Vol.34 No.1

Medication counseling in clinical trials is important for patient safety and implementation of the scientific method. During clinical trials, although basic information about the drug is provided through the participant instructions, there is a lack of research on the extent of the patient awareness of this information, demand for medication guidance by participants, and the appropriate medication guidance methods. A survey was conducted by us in September 2014, enrolling subjects self-administering drugs for a clinical trial, and a study on the principle investigator (PI) and clinical research coordinator (CRC) participating in the clinical trials. The survey related to preferences for medication counseling methods and demand for specific categories, as well as other additional items for clinical trial subjects, to evaluate their awareness of the drugs in the clinical trial. We analyzed the responses of 111 clinical trial subjects and 67 investigators (21 PI and 46 CRC). In terms of preferences for medication counseling methods,‘ written and oral guidance together’was high for both subjects and investigators. When inquired regarding categories for which medication counseling was required, subjects gave the most positive responses for‘ adverse effects’(96.3%) and‘ drug interactions’( 95.4%), while investigators responded highly for ‘methods of use’(100%) and ‘adverse effects’ (100%). The category‘ methods of use’especially showed a significant difference between investigators and subjects in terms of positive response rate, at 100% and 91.7%, respectively (p 0.0001). Categories in which the subjects’awareness of the drugs in the clinical trial was lacking included ‘difference with drugs on the market’(58.6%),‘ interactions with other drugs’(50.5%), and‘ whether the drug is available for sale’(45.1%). Meanwhile, the criteria high on the list of investigators included accurate clinical trials, including guidance about methods of use and dealing with missed doses. Based on the categories revealed by our survey, it will be possible to suggest constituent elements for medication counseling in the future, that accounts for the demands of both subjects and investigators regarding drugs in clinical trials.

일본의 연구자주도 치험(治驗)

안병진,임지연,나가타 류지,최민정,김희정,이종태,임현우,김성묵,전신수 대한임상약리학회 2010 Translational and Clinical Pharmacology Vol.18 No.2

Non-commercial investigator-initiated clinical trials are different from commercial trials sponsored by company according to trial purpose. Irrespective of Korean government’s efforts there are no definite guidelines for investigator-initiated clinical trials using unapproved drugs such as gene materials except clinical research using cell products and market-approved drugs. In USA and EU, the clinical trial results from non-commercial process could be used for marketing approval, if it is proven that the clinical trial has been done according to ICH-GCP guideline. However, In Japan, "chiken (clinical trial)"and "clinical research" are separated. In the clinical research except stem cell and gene therapy, the scientific and ethical aspects of new technology or therapeutics are reviewed only by the institutional review board (IRB), not by the regulatory agency. In the case of "chiken", the applicant has to submit a clinical trial application to the Pharmaceuticals and Medical Devices Agency (PMDA). To reduce administrative burdens and encourage the investigator-initiated trials, investigator-initiated chiken process was developed in Japan. Therefore, to improve and promote the clinical trials initiated by investigator in Korea, it is time to focus on Japan’s investigator-initiated chiken process..

Current Status and Challenges of Cancer Clinical Trials in Korea

심병용,박세훈,이순일,김진수,이경은,강윤구,안명주 대한암학회 2016 Cancer Research and Treatment Vol.48 No.1

Purpose Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems. Materials and Methods We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers in 56 academic hospitals. Results The number of cancer clinical trials approved by the KFDA increased almost twofold from 2007 to 2013. The number of sponsor-initiated clinical trials (SITs) increased by 50% and investigator-initiated clinical trials (IITs) increased by almost 640%. Three hundred and forty- four clinical trials were approved by the KFDA between 2012 and 2013. At the time of the on-line survey (August 2013), 646 SITs and 519 IITs were ongoing in all hospitals. Six high volume hospitals were each conducting more than 50 clinical trials, including both SITs and IITs. Fifty-six investigators (31%) complained of the difficulties in raising funds to conduct clinical trials. Conclusion The number of cancer clinical trials in Korea rapidly increased from 2007 to 2013, as has the number of multicenter clinical trials and IITs run by cooperative study groups. Limited funding for IIT is a serious problem, and more financial support is needed both from government agencies and public donations from non-profit organizations.

사상체질 임상 연구자들의 임상연구에 관한 인식도 조사

유종향,장은수,이혜정,김윤영,김호석,이시우,Yoo, Jong-Hyang,Jang, Eun-Su,Lee, Hae-Jung,Kim, Yun-Young,Kim, Ho-Seok,Lee, Si-Woo 사상체질의학회 2008 사상체질의학회지 Vol.20 No.3

1. Introduction This study aims to survey knowledge and attitude of Sasang constitution investigators on the Sasang constitution clinical study. 2. Methods We have made up list of 24 Sasang constitution investigators who have conducted Sasang constitution clinical study before. The study has been surveyed for 20 investigators who has been experiencing clinical study bye-mail or interview. 3. Results 1) The recognition degree on clinical study for sasang constitutional investigators was relatively lower than that for non-oriental investigators. 2) Most investigators have difficulty in designing a Protocol and they thought Protocol is most important in clinical study. 3) The investigators has stressed the need of diagnosis guideline on Sasang Constitution in performing clinical study. 4. Conclusions Special course of clinical study for sasang constitutional investigators should be prepared to activate Sasang constitution clinical study. This course may set up the guideline of sasang constitution clinical study and designing protocol. Also it is urgent to develop constitution diagnosis guideline for clinical study.

공익목적 임상연구 요양급여 적용 현황분석 및 개선방안

홍미영,김세린,위세아 건강보험심사평가원 심사평가정책연구소 2023 연구보고서 Vol.2023 No.0

The Standards for the Application of National Health Insurance Benefits for Clinical Research was implemented in May 2018 to cover the routine care costs of clinical research for public benefit, in order to expand treatment opportunities for new medical technologies in situations where patients have no alternative treatment options. Since the implementation, there has been a consensus on the significance and necessity of the project, but the consensus is still weak in terms of activation and advancement of the project. In this study, I identified the current situation by analyzing domestic and foreign clinical research support cases and data on applications and claims. I prepared improvement strategies for the clinical research medical benefits for public interest purposes based on the situation analysis and a collection of stakeholder opinions. The results of the domestic clinical research support system showed that the government and public institutions provide research funds and infrastructure for research related to rare, terminal, and severe diseases for which there is no alternative medical technology, and also consider aspects of research design to confirm clinical utility when selecting eligible clinical studies. A review of clinical research support systems in other countries shows that it is difficult to identify commonalities between the projects. The United States considers the therapeutic purpose, improvement of health outcomes, and appropriateness of the research design, while Japan applies health insurance based on the routine care cost for clinical research with licensing purposes. The United Kingdom and Australia determine support based on whether the research is commercial or non-commercial. As a result of checking the status of applications and claims, the proportion of investigator-initiated clinical studies is high, and the number of clinical studies applying for clinical research medical benefits has been increasing overall. The approval rate of sponsor-initiated clinical studies reviewed by the committee was less than 50%, and there were cases where the sponsor was a non-profit organization or a national research and development project. The results of the stakeholder and expert interviews were mixed, depending on the characteristics and interests of the subjects. Considering the purpose of the system and the status reviewed above, I propose improvements to the system for the purpose of fostering the application of clinical research medical benefits for public interest and rationalizing the application and management standards. Firstly, the application criteria and other systems should be improved in order to expand the number of clinical studies covered by routine care costs and increase the predictability of the review results. Second, to reduce the involvement of for-profit organizations in clinical research outcomes, efforts should be made to expand health insurance coverage of routine care costs as well as long-term support for research and infrastructure through public funds. Finally, it is necessary to establish an infrastructure to manage domestic clinical research from approval by the Ministry of Food and Drug Safety to registration of research results and to identify the status of clinical research so that mid- to long-term planning can be made.

Acupuncture for Osteoporosis: a Review of Its Clinical and Preclinical Studies

Tian Yimiao,Wang Lili,Xu Tianshu,Li Rui,Zhu Ruyuan,Chen Beibei,Zhang Hao,Xia Bingke,Che Yiwen,Zhao Dandan,Zhang Dongwei 사단법인약침학회 2022 Journal of Acupuncture & Meridian Studies Vol.15 No.5

Acupuncture has gained growing attention in the management of osteoporosis (OP). However, a comprehensive review has not yet been conducted on the efficacy and challenges of acupuncture in preliminary research and clinical trials. Therefore, an extensive literature search was conducted using electronic databases, including PubMed (www.ncbi.nlm.nih.gov/pubmed), CNKI (www.cnki.net), and Web of Science, for studies published from the beginning of 2000 to the end of May 2022. Combinations of synonyms for OP, acupuncture, traditional Chinese medicine, clinical trial, preclinical study, and animal experiments were searched. A total of 290 papers were consulted, including 115 reviews, 109 clinical observations, and 66 preclinical studies. There is accumulating evidence to support the beneficial role of acupuncture in preserving bone quality and relieving clinical symptoms based on clinical and preclinical investigations. The top ten most commonly used acupoints are BL23, ST36, BL20, BL11, CV4, GV4, SP 6, KI3, BL18, and GB39. The underlying mechanisms behind the benefits of acupuncture may be linked with the regulation of the hypothalamic-pituitary-gonadal (adrenal) axis and activation of the Wnt/β-catenin and OPG/RANKL/RANK signaling pathways. In summary, strong evidence may still come from prospective and well-designed clinical trials to shed light on the potential role of acupuncture in preserving bone loss. Future investigations are needed to explore the potential underlying mechanisms, long-term clinical efficacy, and compliance of acupuncture in OP management.

체질의학 임상연구자의 피험자 동의서 취득에 대한 인식도 조사

유종향,김윤영,권지혜,박기현,이시우,Yoo, Jong-Hyang,Kim, Yun-Young,Kwon, Ji-Hye,Park, Ki-Hyun,Lee, Si-Woo 사상체질의학회 2011 사상체질의학회지 Vol.23 No.3

1. Objectives: We surveyed the attitude and awareness of Sasang Constitution investigators on informed consent in clinical study. This study was performed in order to improve the quality of ethical aspects in clinical study by surveying the process of obtaining informed consent. 2. Methods: We sent the questionnaire by email to Sasang Constitution investigators who had the experience in clinical study. The question was about the necessity of informed consent and the process of obtaining it. 3. Results: Twenty-two out of 24 questionnaires were collected. All of investigators recognized that informed consent is needed for clinical study. Sixty-four percent of the respondents 'fully' or 'mostly' explained the informed consent but they added only 41% of participants 'fully' or 'mostly' understood. Fifty-four point five percent of respondents provided participants enough time and opportunity to inquire the study in details to decide whether or not to participate in the study, the rest of respondents obtained informed consent without providing enough time for decision. 4. Conclusions: Sasang Constitution investigators had high awareness of necessity for informed consent in clinical study. But participants' understanding was low despite of the degree of investigators' explanation. A various strategies should be designed for improving consent forms and process. Most of all, investigators should make sure that informed consent intends to protect participants and promote ethical research conduct.

감염병 대응 선별진료소 모듈러 성능기준에 관한 연구

염태준,김봉찬,서동구 한국공간디자인학회 2023 한국공간디자인학회논문집 Vol.18 No.7

(Background and Purpose) COVID-19 has brought global awareness and threats to Infectious diseases, emphasizing the importance of rapidly preventing regional spread as a means to reduce the threat of Infectious diseases. Therefore, the Screening clinics established to conduct Exploratory investigations for Infectious diseases have faced challenges such as the prevention of infections among healthcare workers and the shortage of auxiliary facilities as the COVID-19 pandemic has prolonged. In response to this, the Korea Disease Control and Prevention Agency introduced the concept of permanent Screening clinics, but these are limited to city and county public health centers. The efficient response to potential future Infectious diseases lies in the establishment of modular Screening clinics that can be quickly deployed. Therefore, the aim of this research is to propose Performance standards for modular Screening clinics that can provide a rapid response to the local community in the event of an Infectious disease outbreak. (Method) In this study, research was conducted through literature review and exploratory investigation. By examining domestic infectious disease response systems, types of screening clinics, performance standards for infectious disease response facilities domestically and internationally, as well as analyzing previous studies, the necessity and applicable factors for utilizing modular screening clinics were derived. Additionally, issues and requirements of existing screening clinics were identified through exploratory investigation of medical professionals and personnel. By integrating these findings, performance standards (draft) for modular screening clinics were proposed. (Results) Firstly, the exploratory investigation of screening clinics revealed that healthcare professionals expressed a need for improvements in the working environment, safety regarding cross-infections, and enhancements in spaces for suspected infectious individuals. Secondly, in terms of the fundamental direction for utilizing modular facilities as screening clinics, six essential performance requirements were identified: safety, storage, confidentiality, speed, scalability, and adaptability. Thirdly, the spatial configuration of screening clinics was categorized into essential spaces and optional spaces. A total of 11 spaces were outlined with their respective performance standards (draft) for each area. (Conclusions) Modular screening clinics possess crucial features such as rapid deployment, adaptable space, and scalability in comparison to permanent screening clinics. However, due to the difficulty in securing a diverse range of support rooms at the level of permanent screening clinics, it appears that maximum efficiency can be achieved by collaborating with public health centers or similar facilities based on the local conditions. This would be more effective than solely relying on permanent screening clinics.

Sjögren's Syndrome: an Update on Diagnostic, Clinical, and Basic Aspects for Oral Medicine Specialists

이경은 대한안면통증∙구강내과학회 2018 Journal of Oral Medicine and Pain Vol.43 No.4

Sjögren's syndrome (SjS) is a common autoimmune disorder characterized by lymphocytic infiltration in the salivary and lacrimal glands, resulting in severe dry mouth or eyes. As a result, most of SjS patients suffer from oral dryness and can visit the department of oral medicine with or without diagnosis of SjS. Therefore, oral medicine specialist should know clues, which may indicate the diagnosis of SjS, from the clinical and laboratory investigations. By the recent SjS criteria, SjS can be diagnosed by focus score, ocular test staining, Schirmer test, unstimulated whole saliva flow rate, and Anti-SSA/Ro. The aim of this article is to review the diagnostic criteria, clinical investigation, and basic aspect related to SjS and to make oral medicine specialist play an important role in the detection of emerging SjS.

임상시험용의약품의 치료목적사용에 있어 환자로부터의 동의 획득 기준: 임상시험용의약품의 응급사용 및 임상시험과의 비교를 중심으로

김은애 한국의료윤리학회 2016 한국의료윤리학회지 Vol.19 No.2

Legally, the investigational product (IP) can be used only in the clinical trial (CT) since its safety and effectiveness are still under investigation. Nevertheless, on the humanitarian grounds and in the exceptional cases, IP can be used legally for the patients with life-threatening critical illness and no other treatment options (Treatment Use, TU) as well as for those in emergency situation as a result of life-threatening illness (Emergency Use, EU). It is important that informed consent (IC) should be obtained in all cases in which IP is used. However, unlike the cases of CT and EU, there are no specific legal standards regarding IC process for TU, other than that it should be in accordance with the legal standards for obtaining IC for CT. Recently, the Korean Ministry of Food and Drug Safety announced the guideline related to EU and TU, but the specific standards related to obtaining IC for TU were not included in that guideline. So in this article, I propose the ethical and legal standards for obtaining IC for TU. For this, I compare TU with CT and EU to identify their similarities and differences. In particular, I analyze the specific legal standards for obtaining IC for CT and EU. 원칙적으로 임상시험용의약품은 안전성과 유효성을 확인하기 위한 임상시험에만 사용될 수 있다. 그럼에도 불구하고, 생명을 위협하는 중대한 질환을 가지고 있으나 이의 치료를 위해 더 이상 사용할 수 있는 다른 방법이 없는 환자 또는 중대한 질환이 생명을 위협하고 있어 매우 위태로운 상황에 있는 환자에게는 인도적 차원에서 예외적으로 임상시험용의약품의 사용이 허용될 수 있다. 전자에 해당하는 치료 목적사용은 환자의 치료를 목적으로 하기에 후자에 해당하는 응급사용과 목적이 같지만, 그 목적이 치료에 있으므로 비록 임상시험용의약품을 사용하지만 연구를 목적으로 하는 임상시험과는 엄연히 다르다. 이러한 치료목적사용을 위해 환자로부터 동의를 획득하는 일은 임상시험이나 응급사용을 위해 임상시험대상자나 환자로부터 동의를 획득하는 일과 마찬가지로 매우 중요하다. 그런데, 임상시험이나 응급사용에 있어 동의 획득의 방법이나 내용과 관련해서는 법에 기준이 구체적으로 정해져 있는 반면, 치료목적사용에 있어서는 임상시험의 경우에 준하여야 한다는 정도로만 되어 있다. 그리고, 식품의약품안전처가 치료목적사용과 응급사용 관련 가이드라인을 마련하여 발표하였지만, 이에도 동의 획득의 방법이나 내용과 관련한 구체적인 기준은 포함되어 있지 않다. 이에 이 논문에서는 치료목적사용을 임상시험이나 응급사용과 비교하여 그 공통점과 차이점을 확인하고, 임상시험과 응급사용을 위한 동의 획득의 방법이나 내용과 관련한 법적 기준을 살펴봄으로써, 치료목적사용에 있어 환자로부터의 동의 획득 기준을 제시해보고자 하였다.