임상시험 재 참여에 대한 임상시험 피험자의 이해도 및 만족도의 영향

최선,최유리,류병은,한옥연,나현오 한국병원약사회 2011 병원약사회지 Vol.28 No.4

This research was conducted to identify the influence of trial participants’general knowledge and satisfaction in a clinical trial on re-participation. From September 2008 to October 2008, a survey questionnaire was distributed to 108 new clinical trial participants in ongoing clinical trials at the investigated Hospital. The participants’general knowledge and satisfaction were measured using a 5-point Likert scale (from 0 to 4) for general attitude towards clinical trials, information source and motive for clinical trial participation,general knowledge of clinical trials, and satisfaction towards one’s own clinical trial. The response rate was 83.3% and 63.3% of respondents agreed with re-participation. We grouped respondents as ‘re-participation acceptor’and ‘re-participation decliner’based on respondents’intent of re-participation. Most re-participation acceptors had more positive attitude towards clinical trial (p<0.05). Similarly, more re-participation acceptors evaluated their general knowledge level positively, especially for‘ background and objective’,‘ frequency of visit and test’and investigational drug dosing’(p<0.05). Among the investigated items, “interest in trials in general”was the most important factor, while “needs for clinical trial into some area”,and“ subjective satisfaction level”were significant effect factors (p<0.05). According to the results, clinical trial staff should make an effort to interest possible participants by providing proper information, and help them recognize the need for clinical trials and the benefits of clinical trials through consistent communication.

임상시험 참가 동의에 관한 연구 - EU의 제한능력자 보호를 중심으로 -

이재호 경북대학교 법학연구원 2020 법학논고 Vol.0 No.69

Clinical trials can be viewed as a civil contract. Particularly, clinical trial contracts are mostly those that can not be acquired personally if there is no information about the clinical trial in advance, and if the clinical trial information is not provided. Thus, providing information about these trial participants is a key element of the contract, and according to this information, participants will decide to participate in clinical trials. Therefore, the intention of participating in clinical trials based on this information is recognized as a very important legal factor, and it is named as voluntary or informed consent to the information. The Pharmaceutical Affairs Law stipulates the obligation to provide the information of the clinical trial practitioner regarding the clinical trial. The provisions of the Act are defined mainly for the purpose of obtaining the permission of the clinical trial. Actual contents for the actual agreement of the clinical trial participants It seems to be neglected in regulating. In this context, we can suggest the most recently proposed regulations for clinical trials for drugs in the EU. The content of these regulations is a legislative model that can be selected as a direction for improvement in our legislation. 임상시험(clinical trials)은 임상시험자와 임상시험에 참여하는 자와의 합의로 인한 계약이다. 그러나 임상시험자의 자발적인 정보제공이 없다면 임상시험 참가자가 그 임상시험에 대한 구체적인 정보를 획득할 수 없는 정보의 비대칭성이 큰 계약이다. 따라서 이러한 임상시험 참가자에 대한 정보제공이 계약체결을 위한 핵심적인 요소가 된다. 이를 뉘렌베르크 강령 이후부터 정보에 의한 자발적인 동의 또는 정보에 기초한 동의(informed consent)로 명명하고 있다. 임상시험에 관련하여 임상시험 실시자의 정보제공의무에 관해서 우리는 약사법에서 규정하고 있는데, 동법상의 규정은 주로 임상시험의 허가를 위한 내용들 위주로만 규정되어 있고 임상시험 참가자의 동의를 구하기 위한 실질적인 내용을 규정하는 것에는 소홀한 것으로 보인다. 이러한 우리의 법적 현실에 검토할 만한 내용으로 EU에서 최근 제시한 의약품에 관한 임상시험(clinical trials on medicinal products) 규정(Regulation)이 있다. 동 EU의 규정에 따르면 자기결정권 보호를 위해 제한능력자에게 임상시험참여 동의권을 부여하고, 언제든지 그 의사를 철회할 수 있도록 하고 있다. 또한 제한능력자의 임상시험 참여를 위한 정당성도 요구한다. 이런 내용들의 연구는 우리의 입법에 개선방향으로 가치 있는 것이 될 것이다.

의약품 임상시험 및 피험자 동의서에 대한 인식도

이성희,최병인,김철민,김경수 대한임상약리학회 2009 Translational and Clinical Pharmacology Vol.17 No.1

Background: The questionnaires were answered by the patients and their family members who visited the hospitals, the staffs in the hospitals, and the personnels who are involved with clinical trials such as the physicians, pharmacists and nurses for the purpose of surveying the cognition on clinical trial and informed consent. This study was performed in order to provide with the basic information and/or data for supporting to motivate the clinical trials by analyzing the factors affecting the difference of the cognition on each item. Method: The number of whom responded to the questionnaires was 310 in total, which was composed with 137 patients and their family members, 109 staffs in the hospitals, and 64 personnels involved with clinical trials. Result: Most of them were well acquainted with clinical trial, and knew that it is the processes to identify the safety and efficacy with the patients and it has been done in the big hospitals like university hospitals. As the results of surveying the cognition on the processes of clinical trials, most of them were known well but something was not recognized like the patients’ right to see their medical history records. While the expectation which can be obtained by participating in clinical trials was not so big, the biggest one was to get more advantageous benefits (efficacy) from clinical trial. With regard to the cognition on the informed consent, it was well understood its basic concept and procedures. The responders who participated in clinical trials before answered they regard that to conduct the clinical trial is more ethic and the mandatory process to develop the new drugs rather than what those that did not participated in the clinical trials, by 2.0 and 2.7 times, respectively. From the points of general relations considering the participation in clinical trials, the persons with diseases show more experience to participate in it, by 5.8 times, rather than those without diseases, and the persons with medication have 4.8 times more experience in participate in clinical trials than those who do not take the drugs. In addition, the persons who have participated in clinical trials showed more willingness to participate in clinical trials than those who have not participated in it. Conclusion: From the survey results by the questionnaire, considering the current circumstances that the numbers of clinical trials has been rapidly increasing, it was found and is recommended that the persons participating in clinical trials should continuously give the patients and their family members more correct and useful knowledge and information on clinical trials and at the same time that the patients should make their efforts to acquire the adequate information and their duties on clinical trials and make decision of their participation in clinical trials by themselves. Background: The questionnaires were answered by the patients and their family members who visited the hospitals, the staffs in the hospitals, and the personnels who are involved with clinical trials such as the physicians, pharmacists and nurses for the purpose of surveying the cognition on clinical trial and informed consent. This study was performed in order to provide with the basic information and/or data for supporting to motivate the clinical trials by analyzing the factors affecting the difference of the cognition on each item. Method: The number of whom responded to the questionnaires was 310 in total, which was composed with 137 patients and their family members, 109 staffs in the hospitals, and 64 personnels involved with clinical trials. Result: Most of them were well acquainted with clinical trial, and knew that it is the processes to identify the safety and efficacy with the patients and it has been done in the big hospitals like university hospitals. As the results of surveying the cognition on the processes of clinical trials, most of them were known well but something was not recognized like the patients’ right to see their medical history records. While the expectation which can be obtained by participating in clinical trials was not so big, the biggest one was to get more advantageous benefits (efficacy) from clinical trial. With regard to the cognition on the informed consent, it was well understood its basic concept and procedures. The responders who participated in clinical trials before answered they regard that to conduct the clinical trial is more ethic and the mandatory process to develop the new drugs rather than what those that did not participated in the clinical trials, by 2.0 and 2.7 times, respectively. From the points of general relations considering the participation in clinical trials, the persons with diseases show more experience to participate in it, by 5.8 times, rather than those without diseases, and the persons with medication have 4.8 times more experience in participate in clinical trials than those who do not take the drugs. In addition, the persons who have participated in clinical trials showed more willingness to participate in clinical trials than those who have not participated in it. Conclusion: From the survey results by the questionnaire, considering the current circumstances that the numbers of clinical trials has been rapidly increasing, it was found and is recommended that the persons participating in clinical trials should continuously give the patients and their family members more correct and useful knowledge and information on clinical trials and at the same time that the patients should make their efforts to acquire the adequate information and their duties on clinical trials and make decision of their participation in clinical trials by themselves.

임상시험 관련 법제의 문제점과 개선방안

이은영 전북대학교 동북아법연구소 2020 동북아법연구 Vol.13 No.3

Today, formal and informal clinical trials have become part of our lives. Aside from the underlying questions and concerns about the nature of clinical trials that test drugs or devices for which human safety has not been confirmed, it is doubtful whether the various clinical trials that are widely conducted today are fair and transparent. Recently, KolonTissuegean's Invossa, which received a license from the Food and Drug Administration due to the submission of false data in Korea, clearly proves this. However, in Japan, a medically advanced country, the inadequacy of clinical trials of Novartis's anti-hypertensive drug Diovan was debated many years ago. Representative laws governing clinical trials include the Bioethics and Safety Act and the Pharmacy Act. Because both laws contain individual content about clinical research, a wide range of legal gaps arise in the area of ​​legal system governing clinical research. In the case of clinical trials involving economic interests with pharmaceutical companies, there is an urgent need to improve the legal system. Regarding the legal rules for clinical trials, a clinical research method to prevent cheating in clinical trials has recently been enacted in Japan, which is considered more passive than Korea, and has been in effect since April 1, 2018. The medical incidents related to clinical trials over the past several years have shifted to active institutional interventions in the medical and pharmaceutical fields, which were previously recognized as the autonomous domain of experts and had minimal restrictions. In Korea, it is time to deepen the concern about improving the overall legal system for clinical trials. Korea's current legislation on clinical trials, referred to as the “gold standard” of medical health research, is not systematic and decentralized. Unnecessary and inefficient related systems need to be drastically abolished or revised. However, the question of how to obtain results that are beneficial to patients and society while securing the safety of participants or patients in clinical trials is an issue that should be constantly considered when seeking ways to improve legislation on clinical trials. 오늘날 임상시험의 일상화, 나아가 임상시험의 국제화 및 산업화로 인하여 파생되는 각종 문제에 대응하기 위한 법제도의 정비는 비단 우리만의 문제는 아닐 것이다. 우리나라에서는 이제 첨단재생의료법의 시행과 맞물려 임상시험에 관한 전반적인 법제도의 정비에 대한 고민이 깊어지는 시점이다. 임상시험에 대한 법적 규율과 관련해서는 우리나라보다 소극적이라고 평가받는 일본에서도 최근 임상시험의 부정행위를 방지하기 위한 임상연구법이 제정되어 이미 2018년 4월 1일 부터 시행되고 있다. 지난 수년간 임상시험과 관련한 사회적인 사건들이 잇따르면서 기존에 전문가의 자율영역으로 인정되어 최소한의 규제만 가해졌던 의·약학 분야에 적극적인 제도적 개입으로 방향이 전환된 것이다. 우리나라에서 임상시험을 규율하는 대표적인 법률로는 생명윤리 및 안전에 관한 법률과 약사법이 있다. 두 법률 모두 임상연구에 관해 개별적인 내용만을 담고 있기 때문에 임상연구를 규율하는 전체 법제도의 영역에서는 광범위한 법적 공백이 발생한다. 특히 제약회사와의 경제적 이해관계가 얽혀 있는 임상시험의 경우 이를 규율할 법적 장치가 없다는 점에서 법제도의 개선이 시급하다. 의학보건 연구의 ‘최적표준(gold standard)’으로 일컬어지는 임상시험에 관한 우리나라의 현행 법제는 체계적이지 못하고 분산되어 있다. 물론 임상시험에 관한 법제도를 정비한다고 하여 모든 문제가 해결되는 것은 아닐 것이다. 병원이나 제약회사에서 관련 법령에서 규정하는 방법과 절차에 따라 공정하고 투명하게 임상시험을 진행하는 것이 중요하다. 잘 설계되고 수행되는 임상시험은 연구 참여자의 복지를 침해하지 않고 보건의료의 문제에 대한 해답을 제시할 수 있다. 그럼에도 불구하고 임상시험에 대한 체계적인 규제를 통하여 임상시험의 공정성 및 투명성을 제고할 수 있는 기초를 마련한다는 점을 감안하면 임상시험에 대한 법제의 정비는 더 이상 미룰 수 없는 시급한 과제가 아닐 수 없다.

종이기반 임상시험의 문제와 개선을 위한 정보기술

김옥구,김선하,김주한,배균섭,김화정,박병주,Kim, Ok-Gu,Kim, Seon-Ha,Kim, Ju-Han,Bae, Kyun-Seop,Kim, Hwa-Jung,Park, Byung-Joo 대한임상약리학회 2003 Translational and Clinical Pharmacology Vol.11 No.2

Despite the importance of clinical trials in developing a new drug, paper based clinical trial is still costly and time-consuming. The process of a clinical trial has not kept up with available information technologies. We identify two major problems in paper based clinical trial. They are time delay and poor error control. To solve the problems information technologies are used in certain areas of clinical trial, but it is still restricted and partially helpful. This paper first explains the two problems in the process of paper based clinical trial and introduces four available information technologies that can help clinical trial in implementing electronic clinical trial (ECT), where information technologies are used in the whole process of clinical trial.

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.

Adaptive design clinical trials: current status by disease and trial phase in various perspectives

Hyunjoon Lee,Sejung Hwang,In-Jin Jang,Jae-Yong Chung,Jaeseong Oh 대한임상약리학회 2023 Translational and Clinical Pharmacology Vol.31 No.4

An adaptive design is a clinical trial design that allows for modification of a structured plan in a clinical trial based on data accumulated during pre-planned interim analyses. This flexible approach to clinical trial design improves the success rate of clinical trials while reducing time, cost, and sample size compared to conventional methods. The purpose of this study is to identify the current status of adaptive design and present key considerations for planning an appropriate adaptive design based on specific circumstances. We searched for clinical trials conducted between January 2006 to July 2021 in the Clinical Trials Registry (ClinicalTrials.gov) using keywords specified in the Food and Drug Administration Adaptive Design Clinical Trial Guidelines. In order to analyze the adaptive designs used in selected cases, we classified the results according to the phase of the clinical trial, type of indication, and the specific adaptation method employed. A total of 267 clinical trials were identified on ClinicalTrials.gov. Among them, 236 clinical trials actually applied adaptive designs and were classified according to phase, indication types, and adaptation methods. Adaptive designs were most frequently used in phase 2 clinical trials and oncology research. The most commonly used adaptation method was the adaptive treatment selection design. In the case of coronavirus disease 2019, the most frequently used designs were adaptive platform design and seamless design. Through this study, we expect to provide valuable insights and considerations for the implementation of adaptive design clinical trials in different diseases and stages.

암환자의 항암제 임상시험에 대한 인식과 만족도

전주경,김정혜 대한종양간호학회 2019 Asian Oncology Nursing Vol.19 No.1

Purpose: The purpose of this study was to investigate the perception and satisfaction of cancer patients participating in clinical trials ofanticancer drugs and the factors affecting their satisfaction. Methods: The participants were cancer patients who participated in morethan two cycles of clinical trials at a tertiary hospital in Seoul, Korea. Questionnaires were used to assess the perception and satisfactionof clinical trials of anticancer drugs. Results: A total of 106 patients participated. The average perception and satisfaction regarding clinicaltrials among patients on a 5 point scale was 3.99±0.45 and 4.09±0.55 respectively. There was a significant difference in the correlationamong participants’ perception and their satisfaction (r =.67, p<.001). Regression analysis revealed that satisfaction was explained by, perception of clinical trials (β =.67, p<.001), participation period 30~59 days (β =.21, p=.009), and participation period over 60 days(β=.20, p=.013). These variables explained 48.7% of the variance of clinical trial satisfaction. Conclusion: The results of this study suggestthat changes in perceptions of clinical trials are needed to improve satisfaction of anticancer drug clinical trials. This can be used asa basis for improving the quality of clinical trials and education programs for cancer patients participating in clinical trials. Purpose: The purpose of this study was to investigate the perception and satisfaction of cancer patients participating in clinical trials ofanticancer drugs and the factors affecting their satisfaction. Methods: The participants were cancer patients who participated in morethan two cycles of clinical trials at a tertiary hospital in Seoul, Korea. Questionnaires were used to assess the perception and satisfactionof clinical trials of anticancer drugs. Results: A total of 106 patients participated. The average perception and satisfaction regarding clinicaltrials among patients on a 5 point scale was 3.99±0.45 and 4.09±0.55 respectively. There was a significant difference in the correlationamong participants’ perception and their satisfaction (r =.67, p<.001). Regression analysis revealed that satisfaction was explainedby, perception of clinical trials (β =.67, p<.001), participation period 30~59 days (β =.21, p=.009), and participation period over 60 days(β=.20, p=.013). These variables explained 48.7% of the variance of clinical trial satisfaction. Conclusion: The results of this study suggestthat changes in perceptions of clinical trials are needed to improve satisfaction of anticancer drug clinical trials. This can be used asa basis for improving the quality of clinical trials and education programs for cancer patients participating in clinical trials.

임상시험정보시스템 현황분석과 적용방안 모색

정순옥,권수경,최인영 대한임상약리학회 2008 Translational and Clinical Pharmacology Vol.16 No.2

Background: Over the past decade, pharmaceutical companies have introduced a number of initiatives to boost the productivity of clinical trials. In clinical trials, this can take to reduce costs and durations of that are being considered in applying information technology. One of these initiatives has been the rollout of electronic data capture (EDC) systems, which allow patients and researcher to enter their trial information directly, either in electronic diaries or online systems. The utilization rate of the EDC in the United States is 41.5%, and similar trends can be seen in 40.5% in Japan. Objectives: Currently, the adoption of EDC in Korea is also getting increased, so the current status of EDC application should be assessed in clinical trials. The aim of this study was identified in present status of EDC system and to improvements to develop it. Method: The survey of participants has been accomplishment in a clinical research coordinator workshop and e-CRF System workshop, which was held in a University Hospital, located in Seoul. The main questionnaire items were 14 including the career of EDC system. Totally, 109 responses were classified by fields of clinical trials study, and comparison analyzed each questionnaire items. Result: The survey of participants has been separated pharmaceutical company participants (39.4%), contract research organization or clinical research associate participants (26%), investigator (research coordinator) (24%), and other participants (10.6%). Current EDC System applied Phase III(40.0%) and will plan to use of system Phase I(34.5%), Phase II(16.7%) Conclusion: EDC systems are increasingly applied for clinical trials and current status of EDC system was assessed in this study. To increase the adoption of the EDCs, the related regulations should be developed, and also decision makers need to understand the importance of information technology in clinical trials. Background: Over the past decade, pharmaceutical companies have introduced a number of initiatives to boost the productivity of clinical trials. In clinical trials, this can take to reduce costs and durations of that are being considered in applying information technology. One of these initiatives has been the rollout of electronic data capture (EDC) systems, which allow patients and researcher to enter their trial information directly, either in electronic diaries or online systems. The utilization rate of the EDC in the United States is 41.5%, and similar trends can be seen in 40.5% in Japan. Objectives: Currently, the adoption of EDC in Korea is also getting increased, so the current status of EDC application should be assessed in clinical trials. The aim of this study was identified in present status of EDC system and to improvements to develop it. Method: The survey of participants has been accomplishment in a clinical research coordinator workshop and e-CRF System workshop, which was held in a University Hospital, located in Seoul. The main questionnaire items were 14 including the career of EDC system. Totally, 109 responses were classified by fields of clinical trials study, and comparison analyzed each questionnaire items. Result: The survey of participants has been separated pharmaceutical company participants (39.4%), contract research organization or clinical research associate participants (26%), investigator (research coordinator) (24%), and other participants (10.6%). Current EDC System applied Phase III(40.0%) and will plan to use of system Phase I(34.5%), Phase II(16.7%) Conclusion: EDC systems are increasingly applied for clinical trials and current status of EDC system was assessed in this study. To increase the adoption of the EDCs, the related regulations should be developed, and also decision makers need to understand the importance of information technology in clinical trials.

Regulation and status of herbal medicine clinical trials in Korea: a narrative review

이보람,Yujin Choi,Pyung-Wha Kim,Chang-Sop Yang,이명수 한국한의학연구원 2021 Integrative Medicine Research Vol.10 No.2

Background: Herbal medicine has been used frequently in Korean medicine. We aimed to summarize the relevant regulations for herbal medicine clinical trials and to analyze their current status in the Republic of Korea. Methods: We searched for legislation to find regulations on herbal medicine clinical trials. Additionally, the websites of the Korean Ministry of Food and Drug Safety (KMFDS) and Clinical Research Information Service (CRIS) were searched to investigate the current status of them. Results: To conduct herbal medicine clinical trials for new drugs or previously approved drugs outside of indications, investigational new drug (IND) approval should be obtained from the KMFDS. For clinical trials of herbal medicines that have been used for more than 3 years with 200 cases at the clinical trial institution, nonclinical data can be exempted from IND approval. Total 95 and 108 herbal medicine clinical trials from the KMFDS and CRIS websites were analyzed. The number of clinical trials showed an increasing trend each year, as did KMFDS-regulated clinical trials. Recently, three clinical trials targeting new herbal formulations frequently used in Korean medicine institutions have been approved based on relevant regulations. Conclusion: We confirmed that herbal medicine clinical trials are managed through strict regulations, which can ensure the safe and effective use of herbal medicine. Despite strict regulations, attempts to accumulate evidence through clinical trials for herbal medicine are increasing. High-quality clinical trials should be conducted to develop new drugs that reflect the clinical setting using relevant regulations, evaluate the efficacy and safety of the drugs, and strengthen insurance coverage.