• Journal of the Society of Disaster Information
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• v.17 no.4
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• pp.778-785
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• 2021

Purpose: The study is to analyze the current status of international clinical trial information services related to COVID-19 and to find out the impact of disclosing activities of clinical trial registration on the medical and pharmaceutical industry. Method: To achieve the purpose of the study, this study analyzed the current status of 780 registered clinical trials for COVID-19 during March of 2020 by using regression analysis. Result: The analysis of clinical trial research registration information showed and proved its usefulness for the development of related new drugs, treatments, vaccines, predictive and prognostic diagnostic kits and treatments related to the COVID-19 (Corona 19) in the world. Conclusion: The study concludes and urges all medical and pharmaceutical companies to register their trials on CRIS and recommends utilizing this registered data to develop advanced drug to benefits all patients related to COVID-19.

• Journal of Oriental Neuropsychiatry
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• v.34 no.3
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• pp.213-234
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• 2023

Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.3
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

• The Journal of Pediatrics of Korean Medicine
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• v.38 no.1
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• pp.55-77
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• 2024

Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

• The Journal of Pediatrics of Korean Medicine
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• v.36 no.3
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• pp.1-18
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• 2022

Objectives The purpose of this study was to investigate the current status of interventional clinical trial registration for children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean medicine treatment of precocious puberty. Methods The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search terms, 'Precocious puberty', 'child'. All clinical trials which were registered as of June 2022 were used. Results For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in 41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8% of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were also reported. Conclusions In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine treatment of precocious puberty.

• The Journal of Internal Korean Medicine
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• v.41 no.3
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• pp.350-361
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• 2020

Objective: This study aimed to report the therapeutic effect of acupuncture on chemotherapy-induced peripheral neuropathy (CIPN). Methods: The articles were sourced from databases including PubMed, EMBASE, Cochrane Library, CNKI, CiNii, WHO ICTRP, JSOM, KMBASE, KISS, NDSL, and OASIS as of July 2019. The main search keywords were peripheral neuropathy and acupuncture, and only randomized controlled trials using acupuncture for therapeutic purposes were included. Cochrane's risk of bias was used to assess the risk of bias, and the Review Manager 5.3 program was used for meta-analysis. Results: Six studies with a total 394 participants were included. When combined treatment of acupuncture and usual care was compared with usual care alone, quality of life improved more significantly in the combination treatment group (SMD=-2.71, 95% CI: -5.01 to -0.41, P=0.02, I²=97%). The CIPN pain score was lower among the combination treatment group, but not to a significant degree (SMD=-2.55, 95% CI: -5.14 to 0.04, P<0.05, I²=98%). There were no severe side effects in any studies. Conclusion: Acupuncture combined with usual care may be considered to safely relieve CIPN pain and improve quality of life for cancer patients. However, as there are few randomized controlled trials studying the effect of acupuncture on CIPN, further well-designed research is needed.

• Proceedings of the Korean Society for Information Management Conference
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• 2017.08a
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• pp.104-104
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• 2017

연구 데이터란 과학적 연구에서 사용된 일차 자료와 연구자에 의해 직접 작성된 연구의 결과로서 수치, 문자, 이미지, 음성 등의 사실적 기록을 의미한다. 이 연구의 주제 분야인 의학은 잠재적 가치와 활용 가능성이 높고 공익적 성격을 가지고 있는 학문 분야로 의학 연구 데이터의 종류와 관리의 필요성을 통해서 그 가치와 공유 의미를 찾아보고자 한다. 또한 연구 데이터의 대표적인 임상 시험 기록과 연구 논문의 발표와 공유 현황에 대해서도 살펴보고 그 안에서 도서관의 역할이 어떤 것인가를 짚어보고자 한다. 의학 연구 데이터는 환자 진료기록, 건강 검진 기록, 임상 기록, 사망 기록, 임상 시험 기록, 유전체 정보, 연구 논문 등 그 종류와 형태가 다양하며 대용량인 경우가 많다. 의학 연구는 개인 정보보호와 윤리적인 문제 등 연구 수행 과정에서 어려운 점이 많은 성격을 가지고 있으나 질병 치료나 예방 나아가 인류의 건강과 직접적으로 관련된 학문 분야로 의학 연구 데이터의 보존과 공개, 공유를 위한 관리는 큰 의미가 있다. 의학 연구 데이터관리는 새로운 연구의 밑받침이 될 뿐만 아니라 중 저개발 국가의 연구자들에게도 큰 기회를 부여하여 세계적인 의학 발전에 기여할 수 있다. 또한 임상 시험 결과에 대한 은폐와 거짓 연구 방지에도 의미가 있어 미국뿐만 아니라 전세계적으로 학술 연구 논문 발표에 사용된 데이터는 등록하도록 규정하고 있다. 임상 시험 등록으로 공인된 사이트는 NIH의 ClinicalTrials.gov, ICTRP의 Primary Registry 등이 있으며, 우리나라에도 질병관리본부 국립보건연구원에서 관리하는 CRIS 등이 있다. 의학 연구자들은 연구의 시작부터 연구 데이터를 수집, 사용, 보존, 공유의 문제를 고려해야 하나 시간적 물리적인 문제 등으로 어려움을 겪고 있으며, 이를 지원하는 서비스는 도서관에서도 관심이 높아지고 있는 분야로 Virginia Commonwealth 대학 도서관과 Emory 대학 도서관 등에서 시도되고 있다. 이 서비스는 연구 과정에서 사서의 지원이 가능한 새로운 기회로 연구자의 데이터관리를 위한 단계별 스토리를 조직하고 DMP 작성 지원 및 교육 등을 통해서 학술 커뮤니케이션에서 새로운 역할자로 자리잡을 수 있을 것이다.