• Translational and Clinical Pharmacology
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• 제26권4호
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• pp.172-176
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• 2018

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 2007년도 추계학술대회
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• pp.88-88
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• 2007

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• 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.

• 한국임상약학회지
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• 제34권2호
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• pp.134-139
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• 2024

Background: Increasing numbers of studies and research about artificial intelligence (AI) and machine learning (ML) have led to their application in clinical trials. The purpose of this study is to analyze computer-based new technologies (AI/ML) applied on clinical trials registered on ClinicalTrials.gov to elucidate current usage of these technologies. Methods: As of March 1st, 2023, protocols listed on ClinicalTrials.gov that claimed to use AI/ML and included at least one of the following interventions-Drug, Biological, Dietary Supplement, or Combination Product-were selected. The selected protocols were classified according to their context of use: 1) drug discovery; 2) toxicity prediction; 3) enrichment; 4) risk stratification/management; 5) dose selection/optimization; 6) adherence; 7) synthetic control; 8) endpoint assessment; 9) postmarketing surveillance; and 10) drug selection. Results: The applications of AI/ML were explored in 131 clinical trial protocols. The areas where AI/ML was most frequently utilized in clinical trials included endpoint assessment (n=80), followed by dose selection/optimization (n=15), risk stratification/management (n=13), drug discovery (n=4), adherence (n=4), drug selection (n=1) and enrichment (n=1). Conclusion: The most frequent application of AI/ML in clinical trials is in the fields of endpoint assessment, where the utilization is primarily focuses on the diagnosis of disease by imaging or video analyses. The number of clinical trials using artificial intelligence will increase as the technology continues to develop rapidly, making it necessary for regulatory associates to establish proper regulations for these clinical trials.

• 한국의료질향상학회지
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• 제27권1호
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• pp.20-25
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• 2021

Purpose: The ability to access clinical trials for cancer treatment is important. This study investigated whether regional differences exist in oncologic clinical trial protocols conducted in South Korea. Methods: Records of all approved oncologic clinical trials conducted in 2019 were downloaded from the Republic of Korea Ministry of Food and Drug Safety. The study covered Seoul, the capital area, other metropolitan cities, and provincial areas. Descriptive statistics summarized the distribution patterns of clinical trials by region. Results: A total of 202 oncologic clinical trials were conducted in 63 institutions in 2019. Of these protocols, 186 (92%) were available in Seoul, 120 (59%) in the capital area, 64 (32%) in metropolitan cities, and 66 (33%) in provincial areas. More regional differences in protocol availability were observed in domestic trials, investigator-initiated trials, phase 1 and 2 trials, and smaller-scale trials. Conclusion: Most oncologic clinical trials were conducted in medical institutions located in Seoul, with the rest conducted in the capital area, metropolitan cities, and provincial areas. The findings reveal clear differences in protocol availability between Seoul and the other regions. Measures designed to improve geographical access to oncologic clinical trials may be needed given their growing importance in cancer treatment.

• 대한한방내과학회지
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• 제41권6호
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• pp.959-966
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• 2020

Objectives: To examine the fundamental characteristics of interventional clinical trials registered in the CRIS (Clinical Research Information Service) database. Methods: We systematically analyzed the status of Korean medical interventions using the search function of the CRIS database. Results: From 2010 to January 2020, 267 Korean medicine-related clinical trials were registered with CRIS. The studies, which included many randomized trials (80.14%), focused primarily on demonstrating the effectiveness and safety of acupuncture and Korean herbal remedies. Most of these studies were government-sponsored and researcher-led clinical trials, but a few were company-sponsored trials. All trials were small and need improvement. Conclusion: This study reviews the current status of clinical trials in the field of Korean medicine and the basic data that can be used to create evidence-based Korean medicine.

• 동의신경정신과학회지
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• 제24권3호
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• pp.201-210
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• 2013

Objectives : To review the recent trend of randomized controlled clinical trials on insomnia and to provide information for future clinical trials. Methods : A total of 667 pieces of literature were searched using the key words 'insomnia' and 'randomized controlled trial' and using the title 'insomnia' with the topic 'trial or trials', published from 2008 to 2012 through Web of Science. Studies including randomized controlled clinical trials were sorted from the search result and finally 104 pieces of the literature were selected and examined. Results : Besides 104 clinical trials, 14 trials related to CAM (Complementary and Alternative Medicine) were also reviewed. On average, 20 trials were annually conducted and they showed a growing trend. Participants were between 31 and 90 (34.6%), and were observed for less than 30 days (28.8%) in most trials. As intervention methods for clinical trials, non-pharmaceutical methods were used in 59 studies (56.7%), pharmaceutical drug in 43 studies (41.3%) and combinations in 2 studies (1.9%). In 60 studies, only insomnia without any underlying diseases was examined and other 44 studies involved other diseases. As diagnosis assessment tools, Sleep diary and Polysomnography were used. Conclusions : Randomized controlled trials relevant to insomnia were on the increase, but only a small number of clinical trials on Oriental Medicine have been performed. Larger scientific and well-founded randomized controlled trials are required for developing Oriental Medicine and establishing high-quality guideline going forward.

• Translational and Clinical Pharmacology
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• 제26권3호
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• pp.101-102
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• 2018

• 한국임상약학회지
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• 제5권2호
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

• Restorative Dentistry and Endodontics
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• 제49권1호
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• pp.5.1-5.11
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• 2024

Objectives: This study aimed to present the results and analyses of clinical trials, including updates on the different functions of root canal sealers. Materials and Methods: In June 2023, we performed a comprehensive search of ClinicalTrials.gov to identify interventional clinical trials pertaining to root canal sealers. In total, 23 clinical trials conducted up to June 2023 were included in this study. Results: Approximately half of the trials (11 out of 23) were completed, while none were terminated or withdrawn. Each included trial had a minimum of 10 participants, with 11 trials having more than 100 participants. None of the assessed trials provided outcomes, and the majority (17 out of 23) lacked associated publications. In terms of geographic distribution, the USA and Canada did not contribute to any root canal sealer trials. Conclusions: This study highlights the lack of diversity in trial locations, the absence of reported results, and a scarcity of clinical trials examining the physicochemical properties of different sealers. Most published trials primarily focused on assessing the post-operative pain effect of these sealers, but no significant difference was found regarding post-operative pain control.