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.

의약품 임상시험에서 피험자 보호

위계찬 대한의료법학회 2012 의료법학 Vol.13 No.2

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.

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.

웹 기반 임상시험의 윤리적 고찰

김영옥(Kim, Young Ok),최병인(Choe, Byung In) 가톨릭생명윤리연구소 2018 인격주의 생명윤리 Vol.8 No.1

웹(web) 기반 임상시험은 임상시험 대상자가 임상시험 실시기관을 방문하지 않고 온라인으로 임상시험에 참여하는 것으로 임상시험의 전 과정이 모바일 기기, 컴퓨터 장치, 인터넷과 같은 전자 기술 (e-technology)을 최대한 활용하여 이루어진다. 이러한 방법은 최소한의 임상시험 기반시설을 바탕으로 대규모 잠재적 임상시험 대상자의 연구 참여를 간소화하고, 효율적인 데이터 수집과 분석을 통해 임상시험에 소요되는 시간을 단축시키며 비용을 절감하는 하나의 혁신적인 방법으로 평가된다. 그러나 웹 기반 임상시험은 우리 생활 속에 깊숙이 관여하고 있는 인터넷과 개인 기반의 전자 기술을 사용하는 고유한 특성 때문에 순기능(順機能)과 함께 기존의 임상시험 실시기관을 방문하는 임상시험에서는 볼 수 없었던 새로운 임상시험 관련 문제와 윤리적 문제들을 가지고 있을 수 있다. 2011년 미국의 제약회사 화이자(Pfizer)가 실시한 최초의 웹 기반 의약품 임상시험은 대상자 모집과 사전 선별과정, 대상자 전자동의, 대상자의 데이터 직접 보고 등 임상시험의 전 과정이 온라인으로 이루어져 전자 기술을 이용한 원격(remote) 임상시험의 응용과 발전에 도화선(導 火線)이 되었다. 하지만 웹 기반 임상시험은 임상시험 대상자의 웹 접근성과 기술 선호도 차이, 시험자와 임상시험 대상자의 상호작용이 부족한 전자동의 과정, 임상시험용 의약품 관리 및 이상반응 대응, 데이터의 신뢰성 보장 및 개인정보 보호 등 해결해야 할 과제를 가지고 있다고 하겠다. 따라서 모바일 기술과 컴퓨터 장치, 사물 인터넷(Internet of Things, IoT)과 같은 전자 기술은 계속해서 발전하고 이를 임상시험에 다양하게 적용하려는 시도가 이루어지고 있는 상황에서 웹 기반 임상시험에 대한 이해와 함께 해결해야 할 임상시험 관련 문제 및 윤리적인 문제를 깊이 있게 연구할 필요가 있다. Web-based or online clinical trials in which patients participate in clinical trials online without visiting clinical trial institutions take full advantage of information technologies, such as mobile devices, computer, internet of things(IOT) and etc. This new emerging methodology is applied from study start-up through execution to follow-up. The method is evaluated as one innovative way to reduce overall clinical trial costs through simplified procedures and to invite participation in larger and more geographically diversified prospective subjects. This also able to collect and analyze data with minimal trial infrastructure. Online clinical trials may have some positive effects but, at the same time, it brings new clinical trial-related and ethical issues that were not seen in the site-based clinical trials due to inherent characteristics of using internet and personal-based electronic technologies that are already integrated into our lives. In 2011, Pfizer conducted the first all-electronic, home-based clinical trial for a drug trial which performed pre-screening, recruiting participants, electronic informed consent, self-reported data by subjects through the study’s online website. It had introduced an opportunity to increase application and development of clinical trials to be done remotely. But there may be challenges at the same time, including the difference of accessibility to internet among the prospective subjects and technology preference between subjects, the process of electronic informed consent, lack of interaction between subjects and investigator, the management of investigational products and adverse event, the assurance for data reliability, privacy and confidentiality. Therefore, there is a need to study in depth for the ethical issues and clinical trial-related issues that need to be addressed as electronic technologies including mobile technology, computer devices, and internet of things(IOT) continue to grow and to apply them to clinical trials.

신약개발과 임상시험에 대한 미국 식품의약품청의 규제 법령에 관한 고찰

박수헌(Park, Soo-Hun) 한양법학회 2010 漢陽法學 Vol.30 No.-

Usually, it takes at least 8 years to develop new drugs. Especially, the clinical trials are required to spend about 5 years. In America, the whole steps for new drug development are provided thoroughly in statutes and regulations of FDA. Most of all, in this paper, I explored FDA’s regulations on the preclinical trials, Good Laboratory Practices, and FDA’s laws & regulations on the clinical trials that are the essential aspects in the new drug development. In order to protect the rights, safeties and welfares of the human research subjects in the clinical trials, FDA established very detailed provisions in the Code of Federal Regulations delegated by the relevant statutes. As mentioned earlier, FDA has exerted itself in recent years to ensure the safety as well as the speedy development of new drugs. The latter has been achieved by enacting PDUFA in 1992(now PDUFA IV from 2008 till 2012), the former is achieved by the thorough FDA regulations on the clinical trials. This paper consists of four chapters. Chapter Ⅰ describes the power of FDA on regulating the whole procedures of new drug development, the history of FDA’s laws and regulations on new drug development, and the purpose of this paper. Chapter Ⅱ examines the purpose, function, and contents of the preclinical trials and Good Laboratory Practices(GLPs). In addition, the methods of sanctions are explored when the clinical sponsor cannot comply with the GLPs. Chapter Ⅲ reveals the details relating to the clinical trials. It includes the contents of Investigational New Drug Application(IND), Informed Consent, IRB, the phases of the clinical trials, sponsor’s collaboration with FDA regarding clinical trials, obligations of clinical sponsors and investigators, expanded access to investigational drugs, clinical hold, IND termination and suspension. Chapter Ⅳ summaries the above mentioned contents in the first half. In the second half, I suggest that the status of KFDA’s guidances is required to be enhanced to the status of C.F.R. in America because they are related to the protection of the rights, safeties and welfares of the human research subjects in clinical trials.

Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development

Park, Yu Rang,Yoon, Young Jo,Koo, HaYeong,Yoo, Soyoung,Choi, Chang-Min,Beck, Sung-Ho,Kim, Tae Won JMIR Publications 2018 Journal of medical Internet research Vol.20 No.4

<P><B>Background</B></P><P>Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations.</P><P><B>Objective</B></P><P>The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations.</P><P><B>Methods</B></P><P>This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations.</P><P><B>Results</B></P><P>In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects.</P><P><B>Conclusions</B></P><P>The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.</P>

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.

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.

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.

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.